search
Back to results

Overcoming Endocrine Resistance in Metastatic Breast Cancer (OVER)

Primary Purpose

Metastatic Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Fulvestrant
Lapatinib
Aromatase Inhibitors
Placebo Lapatinib
Sponsored by
Consorzio Oncotech
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer focused on measuring Fulvestrant, Lapatinib, Aromatase Inhibitor, metastatic breast cancer

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  1. Provision of written informed consent
  2. Histological/cytological confirmation of breast cancer
  3. Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters
  4. Postmenopausal women
  5. Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors
  6. Patients demonstrating prior response to AI therapy
  7. Patients with measurable disease as per RECIST criteria /Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria.
  8. May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry;
  9. Life expectancy of at least 8 months
  10. WHO performance status 0, 1 or 2
  11. Patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence.
  12. Are able to swallow and retain oral medication;
  13. Are able to complete all screening assessments as outlined in the protocol;
  14. Patients must have normal organ and marrow function
  15. Left ventricular ejection fraction (LVEF) within the institutional normal range

Exclusion Criteria:

  1. Previous therapy with Fulvestrant and/or Lapatinib;
  2. Patients with HER 2 overexpressing, either IHC 3+ or FISH +;
  3. Concurrent non study anti-cancer therapy (
  4. Have unresolved or unstable, serious toxicity from prior administration
  5. Have malabsorption syndrome,
  6. Have a concurrent disease or condition that would make the patient inappropriate for study participation,
  7. Have an active or uncontrolled infection;
  8. Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent;
  9. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;
  10. Receive concurrent treatment with an investigational agent or participate in another clinical trial;
  11. Receive concurrent treatment with prohibited medications
  12. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication;
  13. Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.

Sites / Locations

  • A.S.U.R. Zona Territoriale 6 Fabriano U.O. Oncologia MedicaRecruiting
  • Azienda Ospedaliera Treviglio-Caravaggio U.O. Oncologia MedicaRecruiting
  • Ospedale Civile Renzetti U.O. Oncologia MedicaRecruiting
  • Ospedale S. Francesco da Paola U.O. Oncologia Medica
  • IRCCS - 'Casa Sollievo della Sofferenza' U.O. Oncologia MedicaRecruiting
  • Ospedale 'SS. Trinità' U.O. Oncologia MedicaRecruiting
  • Ospedale Unico Versilia U.O. Oncologia MedicaRecruiting
  • Ospedale Civico San Vincenzo U.O. Oncologia MedicaRecruiting
  • Ospedale 'Felice Lotti' - Azienda USL 5 di Pisa U.O. di Oncologia MedicaRecruiting
  • Centro di Riferimento Oncologico S.O.C. di Oncologia Medica CRecruiting
  • Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia MedicaRecruiting
  • Ospedale San Sebastiano Day Hospital Oncologico - Divisione Medicina AcutiRecruiting
  • Azienda Ospedaliera - Ospedale Umberto I U.O. di Medicina e OncoematologiaRecruiting
  • Presidio Ospedaliero di Vallo della Lucania U.O. Oncologia MedicaRecruiting
  • AOVV - Ospedale E. Morelli S.O.C. Medicina Interna - D.H. Oncologico-Ematologico-InternisticoRecruiting
  • Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.) Direzione di Oncologia MedicaRecruiting
  • Ospedale 'S. Antonio Abate' U.O. Oncologia
  • Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero Saronno S.C. Oncologia MedicaRecruiting
  • Ospedale Sacro Cuore - Don Calabria U.O.C. Oncologia MedicaRecruiting
  • Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico U.O. Oncologia Medica e SperimentaleRecruiting
  • Azienda Ospedaliera G. Rummo U.O. di Oncologia MedicaRecruiting
  • Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' U.O. OncologiaRecruiting
  • Presidio Ospedaliero 'Antonio Perrino' U.O.C. di OncologiaRecruiting
  • dazione di Ricerca e Cura 'Giovanni Paolo II' U.O. di Ginecologia OncologiaRecruiting
  • Ospedale Civile di Campobasso - A. Cardarelli U.O.C. Oncologia MedicaRecruiting
  • Azienda Ospedaliera 'Sant'Anna e San Sebastiano' U.O.C. di OncologiaRecruiting
  • Presidio Ospedaliero Garibaldi - Nesima S.C. di Oncologia MedicaRecruiting
  • A.O.U. Ospedale Vittorio Emanuele e Ferrarotto U.O. di Oncologia MedicaRecruiting
  • Humanitas Centro Catanese di Oncologia U.O. Oncologia MedicaRecruiting
  • Azienda Ospedaliera S. Anna U.O. di Oncologia MedicaRecruiting
  • Arcispedaliera S. Anna di Ferrara U.O. Oncologia ClinicaRecruiting
  • I.R.C.C.S. A.O.U. San Martino - I.S.T. S.C. Oncologia Medica ARecruiting
  • ASRM - Ospedale F. Veneziale - Zona di Isernia U.O. OncologiaRecruiting
  • A.S.L. LT - Ospedale Santa Maria Goretti U.O.C. di Oncologia MedicaRecruiting
  • Ospedale Vito Fazzi U.O. di OncologiaRecruiting
  • Istituto Europeo di Oncologia (IRCCS) Dipartimento di Medicina - Unità Cure MedicheRecruiting
  • Azienda Ospedaliera Cardarelli Divisione Di OncologiaRecruiting
  • Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica SenologicaRecruiting
  • Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - OncologiaRecruiting
  • A.O.U. 'Maggiore della Carità' S.C. OncologiaRecruiting
  • Istituto Oncologico Veneto - I.R.C.C.S. U.O. di Oncologia Medica IIRecruiting
  • A.O.U.P. 'Paolo Giaccone' U.O.C. di Oncologia MedicaRecruiting
  • A.R.N.A.S - Ospedale Civico e Benfratelli G. Di Cristina e M. Ascoli Divisione di Oncologia MedicaRecruiting
  • Fondazione S. Maugeri IRCCS U.O. Oncologia Medica IIRecruiting
  • IRCCS Policlinico S. Matteo S.C. di Oncologia Medica
  • Ospedale S. Maria della Misericordia S.C. Oncologia MedicaRecruiting
  • AUSL di Piacenza - Ospedale U.O. Oncologia MedicaRecruiting
  • Azienda Ospedaliera Santa Maria degli Angeli U.O. Oncolgia MedicaRecruiting
  • Azienda Ospedaliera Bianchi - Melacrino - Morelli U.O. di Oncologia MedicaRecruiting
  • Arcispedale S.Maria Nuova Servizio di OncologiaRecruiting
  • Istituto Regina Elena per lo studio e la cura dei tumori S.C. Oncologia Medica ARecruiting
  • Azienda Ospedaliera San Camillo - Forlanini Day Hospital Oncologia MammellaRecruiting
  • Policlinico Universitario 'Agostino Gemelli' U.O.C. Ginecologia OncologicaRecruiting
  • Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina U.O. OncologiaRecruiting
  • Azienda Ospedaliera S. Andrea - Università La Sapienza U.O.C. OncologiaRecruiting
  • Ospedale San Pietro Fatebenefratelli Dipartimento di Oncologia - Day Hospital OncologicoRecruiting
  • Ospedale G. Da Procida - ASL SA U.O. di OncologiaRecruiting
  • Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di OncologiaRecruiting
  • Azienda Ospedaliera n. 1 - Annunziata Oncologia MedicaRecruiting
  • Università di Sassari U.O. di Oncologia MedicaRecruiting
  • Ospedale Civile di Sondrio - Azienda Ospedaliera Valtellina e Valchiavenna S.C. Oncologia MedicaRecruiting
  • Ospedale Evangelico Valdese - ASL TO1 U.O. di Oncologia MedicaRecruiting
  • Presidio San Lazzaro - A.O.U. San Giovanni Battista di Torino (Molinette) S.C. Oncologia Medica IIRecruiting
  • Università degli Studi di Torino - Ospedale S. Anna U.O. di Oncologia MedicaRecruiting
  • Ospedale Mauriziano Umberto I S.C.D.U. Ginecologia e OstetriciaRecruiting
  • Centro Oncologico A.S.S. N°1 Triestina Centro Sociale Oncologico
  • A.O.U. ´S. Maria della Misericordia´ Dipartimento di OncologiaRecruiting
  • Azienda Ospedaliera Circolo e Fondazione Macchi U.O. di Oncologia MedicaRecruiting
  • Presidio Ospedaliero 'Belcolle' U.O.C. Oncologia MedicaRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Experimental

Arm Label

ARM 1

ARM 2

ARM 3

ARM 4

Arm Description

Fulvestrant + Placebo Lapatinib

Fulvestrant + Aromatase Inhibitors + Placebo Lapatinib

Fulvestrant + Lapatinib

Fulvestrant + Lapatinib + Aromatase Inhibitors

Outcomes

Primary Outcome Measures

Progression Free Survival
Progression free survival (PFS): it is defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first.

Secondary Outcome Measures

Time To Progression
Time to Progression (TTP): it is defined as the time between the first study dose administration and the date of progression of the disease or cancer-related death, whichever occurs first.
Overall Survival
Overall survival. (OS): it is defined as the time between the first study dose administration and the date death from any cause.
Response Rate:
Response Rate: It will be classified according to the RECIST criteria.
Clinical Benefit Rate
Clinical Benefit Rate: it is defined as the sum of rates of PR, CR and SD lasting ≥ 6 months.
Safety as measured by expected and Non-expected toxicity events
To evaluate expected and Non-expected toxicity events that occur in more than 5% of patients in any of the study group, as reported by the CTC.
Safety assessed by number of Participants with Adverse Events
Withdrawals from the treatment plan (causes of withdrawals will be compared per each study group).

Full Information

First Posted
December 16, 2014
Last Updated
June 14, 2016
Sponsor
Consorzio Oncotech
search

1. Study Identification

Unique Protocol Identification Number
NCT02394496
Brief Title
Overcoming Endocrine Resistance in Metastatic Breast Cancer
Acronym
OVER
Official Title
A Randomized Trial With Factorial Design Comparing Fulvestrant ± Lapatinib ± Aromatase Inhibitor in Metastatic Breast Cancer Progressing After Aromatase Inhibitor Therapy
Study Type
Interventional

2. Study Status

Record Verification Date
June 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2007 (undefined)
Primary Completion Date
December 2016 (Anticipated)
Study Completion Date
January 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Consorzio Oncotech

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Based on these results it can be envisioned that the majority of endocrine-responsive post-menopausal breast cancer patients will be treated with an AI as adjuvant therapy (front-line, switching or extending) and/or as first-line management of metastatic breast cancer.
Detailed Description
In presence of ER hypersensitivity even a small amount of ER may be sufficient for sustained growth signalling. On the other hand, ER disruption operated by fulvestrant is not complete, particularly in the initial phase of treatment. From phase III trials, indeed, The invertigators know that with the standard 250mg monthly dose the steady state of circulating drug is reached only after 5-6 injections. This may play a role since, as long as ER downregulation is concerned, a clear dose-response relationship has been reported. In such a situation, fulvestrant efficacy may be partial, particularly because the concomitant AI discharge yields a restoration of physiologic postmenopausal levels of circulating oestrogens. New dosing schedule are currently under investigation both to accelerate the achievement of the steady state (loading dose) and to achieve higher circulating drug levels (high dose) (86). In this trial the investigators will be using the so-called 'loading dose'. Further potential strategies to improve fulvestrant efficacy in this setting are: A) avoid the restoration of circulating oestrogens; B) interfere with molecular mechanisms that produce ER hypersensitivity by targeting the EGFR/ERBB2/ERB3 system. A) avoid the restoration of circulating oestrogens: this should be achieved by holding the AI treatment. Because some cases of progression upon AIs may be related to an inefficient inhibition of the aromatase it is a logical step to test whether changing AI class (from type I, steroidal, to type II, non steroidal, and vice-versa) (87), may improve fulvestrant efficay. In this view, pts in this trial will be randomized to receive fulvestrant (loading dose) with or without the alternate class AI treatment. Circulating oestrogens levels will be tracked to verify inhibition of aromatase for pts assigned to concurrent AI treatment. B) Interfere with growth factors-mediated ER hypersensitivity: although fulvestrant is able to overcome the ER hypersensitivity of LTED (88) and produce a growth arrest, this activity may not be complete because of incomplete ER disruption, but also because of a direct stimulation of growth by the hyperactivated EGFR/ERBB2/ERB3 system. Laboratory evidence support this hypothesis. Indeed, breast cancer cell lines exposed to long-term treatment with fulvestrant became insensitive to the drug and restore growth (89). This growth does not appear, however, related to the development of direct resistance to the drug, since ER mediated signalling continue to be efficiently suppressed in these cells; rather it may be driven by the use of alternative growth-stimulating pathway, including the EGFR system. Indeed, it can be abrogated by the EGFR-tyrosine Kinase inhibitor Gefitinib (IRESSA™) and by an MAPK-inhibitor (90). Lapatinib (GW572016) is an orally active small molecule that reversibly inhibits ErbB1 and ErbB2 tyrosine kinases, which in turn blocks phosphorylation and activation of Erk1/2 (p-Erk1/2) and Akt (p-Akt) in ErbB1- and/ or ErbB2-expressing tumor cell lines and xenografts (91-94). Lapatinib elicits cytostatic or cytotoxic antitumor effects depending on the cell type (95;96). Because ErbB2-containing heterodimers exert potent mitogenic signals, simultaneously interrupting both ErbB1 and ErbB2 signaling is an appealing therapeutic approach. Moreover, ErbB3 signaling is also involved in lapatinib action. Indeed ErbB3 is kinase-dead and relies on ErbB2 for transactivation: ErbB2-ErbB3 heterodimers are potent activators of the PI3K-Akt survival pathway (97;98), which can, in turn, inhibited by lapatinib. Based on its molecular mechanism of action, on its fair toxicity profile and on its promising, although preliminary, activity data, Lapatinib appears an ideal candidate to combine with Fulvestrant in the attempt to improve its efficacy in patients progressing on AIs.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer
Keywords
Fulvestrant, Lapatinib, Aromatase Inhibitor, metastatic breast cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Crossover Assignment
Masking
ParticipantCare ProviderInvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
396 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM 1
Arm Type
Experimental
Arm Description
Fulvestrant + Placebo Lapatinib
Arm Title
ARM 2
Arm Type
Experimental
Arm Description
Fulvestrant + Aromatase Inhibitors + Placebo Lapatinib
Arm Title
ARM 3
Arm Type
Experimental
Arm Description
Fulvestrant + Lapatinib
Arm Title
ARM 4
Arm Type
Experimental
Arm Description
Fulvestrant + Lapatinib + Aromatase Inhibitors
Intervention Type
Drug
Intervention Name(s)
Fulvestrant
Other Intervention Name(s)
Faslodex
Intervention Description
Fulvestrant 500mg (2 x 5ml) im injections as a loading dose on Day 0, followed by 500mg (2x5ml) on Day 14 (+/- 3 days) , Day 28 (+/- 3 days) and every 28 Days (+/- 3 days) thereafter.
Intervention Type
Drug
Intervention Name(s)
Lapatinib
Intervention Description
1500mg (TBD) O.S. qd
Intervention Type
Drug
Intervention Name(s)
Aromatase Inhibitors
Other Intervention Name(s)
Aromatase Inhibitor
Intervention Description
as indicated in the Summary Product Characteristic
Intervention Type
Drug
Intervention Name(s)
Placebo Lapatinib
Other Intervention Name(s)
Placebo
Intervention Description
1500mg (TBD) O.S. qd
Primary Outcome Measure Information:
Title
Progression Free Survival
Description
Progression free survival (PFS): it is defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first.
Time Frame
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Secondary Outcome Measure Information:
Title
Time To Progression
Description
Time to Progression (TTP): it is defined as the time between the first study dose administration and the date of progression of the disease or cancer-related death, whichever occurs first.
Time Frame
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Title
Overall Survival
Description
Overall survival. (OS): it is defined as the time between the first study dose administration and the date death from any cause.
Time Frame
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Title
Response Rate:
Description
Response Rate: It will be classified according to the RECIST criteria.
Time Frame
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Title
Clinical Benefit Rate
Description
Clinical Benefit Rate: it is defined as the sum of rates of PR, CR and SD lasting ≥ 6 months.
Time Frame
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 6 months
Title
Safety as measured by expected and Non-expected toxicity events
Description
To evaluate expected and Non-expected toxicity events that occur in more than 5% of patients in any of the study group, as reported by the CTC.
Time Frame
Defined as the time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months
Title
Safety assessed by number of Participants with Adverse Events
Description
Withdrawals from the treatment plan (causes of withdrawals will be compared per each study group).
Time Frame
time between the first study dose administration and the date of progression of the disease or death from any cause, whichever occurs first assessed up to 12 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Provision of written informed consent Histological/cytological confirmation of breast cancer Documented positive hormone receptor status (ER+ve and/or PgR+ve) of primary or metastaic tumor issue, according to the local laboratory parameters Postmenopausal women Confirmed progression of disease after an adjuvant therapy or a therapy for metastatic disease with an aromatase inhibitors Patients demonstrating prior response to AI therapy Patients with measurable disease as per RECIST criteria /Patients with bone lesions, lytic or mixed (lytic + sclerotic), in the absence of measurable disease as defined by RECIST criteria. May have received prior radiotherapy as treatment for primary or metastatic tumour; however, is not required for study entry; Life expectancy of at least 8 months WHO performance status 0, 1 or 2 Patients with a history of other malignancies are eligible if they have been disease-free for at least 5 years and are deemed by the investigator to be at low risk for recurrence. Are able to swallow and retain oral medication; Are able to complete all screening assessments as outlined in the protocol; Patients must have normal organ and marrow function Left ventricular ejection fraction (LVEF) within the institutional normal range Exclusion Criteria: Previous therapy with Fulvestrant and/or Lapatinib; Patients with HER 2 overexpressing, either IHC 3+ or FISH +; Concurrent non study anti-cancer therapy ( Have unresolved or unstable, serious toxicity from prior administration Have malabsorption syndrome, Have a concurrent disease or condition that would make the patient inappropriate for study participation, Have an active or uncontrolled infection; Have dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent; Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF; Receive concurrent treatment with an investigational agent or participate in another clinical trial; Receive concurrent treatment with prohibited medications Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of study medication; Have a known immediate or delayed hypersensitivity reaction or idiosyncrasy to drugs chemically related to fulvestrant, aromatase inhibitors or lapatinib or excipients.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Clinical Research Technology
Phone
0039089301545
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Sabino De Placido, MD
Organizational Affiliation
Dipartimento di Medicina Clinica e Chirurgia Oncologia Università degli Studi di Napoli "Federico II"
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Michelino De Laurentiis, MD
Organizational Affiliation
Istituto Nazionale dei Tumori - Fondazione G. Pascale
Official's Role
Study Chair
Facility Information:
Facility Name
A.S.U.R. Zona Territoriale 6 Fabriano U.O. Oncologia Medica
City
Fabriano
State/Province
Ancona
ZIP/Postal Code
60044
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROSA RITA SILVA, Md
Facility Name
Azienda Ospedaliera Treviglio-Caravaggio U.O. Oncologia Medica
City
Treviglio
State/Province
Bergamo
ZIP/Postal Code
24047
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandro Barni, Md
Facility Name
Ospedale Civile Renzetti U.O. Oncologia Medica
City
Lanciano
State/Province
Chieti
ZIP/Postal Code
66034
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO NUZZO, Md
Facility Name
Ospedale S. Francesco da Paola U.O. Oncologia Medica
City
Paola
State/Province
Cosenza
ZIP/Postal Code
87027
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
IRCCS - 'Casa Sollievo della Sofferenza' U.O. Oncologia Medica
City
San Giovanni Rotondo
State/Province
Foggia
ZIP/Postal Code
71013
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
EVARISTO MAIELLO, Md
Facility Name
Ospedale 'SS. Trinità' U.O. Oncologia Medica
City
Sora
State/Province
Frosinone
ZIP/Postal Code
03039
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
TERESA GAMUCCI, Md
Facility Name
Ospedale Unico Versilia U.O. Oncologia Medica
City
Lido Di Camaiore
State/Province
Lucca
ZIP/Postal Code
55041
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Domenico Amoroso, Md
Facility Name
Ospedale Civico San Vincenzo U.O. Oncologia Medica
City
Taormina
State/Province
Messina
ZIP/Postal Code
98039
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCESCO FERRAÙ, Md
Facility Name
Ospedale 'Felice Lotti' - Azienda USL 5 di Pisa U.O. di Oncologia Medica
City
Pontedera
State/Province
Pisa
ZIP/Postal Code
56025
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Giacomo Allegrini, MD
Facility Name
Centro di Riferimento Oncologico S.O.C. di Oncologia Medica C
City
Aviano
State/Province
Pordenone
ZIP/Postal Code
33081
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SIMON SPAZZAPAN, Md
Facility Name
Ospedale Oncologico Regionale - Centro di Riferimento Oncologico di Basilicata U.O. di Oncologia Medica
City
Rionero in vulture
State/Province
Potenza
ZIP/Postal Code
85028
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Michele Aieta, MD
Facility Name
Ospedale San Sebastiano Day Hospital Oncologico - Divisione Medicina Acuti
City
Correggio
State/Province
Reggio Emilia
ZIP/Postal Code
42015
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALESSANDRA ZOBOLI, Md
Facility Name
Azienda Ospedaliera - Ospedale Umberto I U.O. di Medicina e Oncoematologia
City
Nocera Inferiore
State/Province
Salerno
ZIP/Postal Code
84014
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALFONSO MARIA D'ARCO, Md
Facility Name
Presidio Ospedaliero di Vallo della Lucania U.O. Oncologia Medica
City
Vallo Della Lucania
State/Province
Salerno
ZIP/Postal Code
84078
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PIETRO MASULLO, Md
Facility Name
AOVV - Ospedale E. Morelli S.O.C. Medicina Interna - D.H. Oncologico-Ematologico-Internistico
City
Sondalo
State/Province
Sondrio
ZIP/Postal Code
23035
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GIUSEPPE VALMADRE, Md
Facility Name
Fondazione del Piemonte per l'Oncologia - Istituto di Ricovero e Cura a Carattere Scientifico (I.R.C.C.S.) Direzione di Oncologia Medica
City
Candiolo
State/Province
Torino
ZIP/Postal Code
10060
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Massimo Aglietta, MD
First Name & Middle Initial & Last Name & Degree
Massimo Aglietta, MD
Facility Name
Ospedale 'S. Antonio Abate' U.O. Oncologia
City
Gallarate
State/Province
Varese
ZIP/Postal Code
21013
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Azienda Ospedaliera Busto Arsizio - Presidio Ospedaliero Saronno S.C. Oncologia Medica
City
Saronno
State/Province
Varese
ZIP/Postal Code
21047
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CLAUDIO VERUSIO, Md
Facility Name
Ospedale Sacro Cuore - Don Calabria U.O.C. Oncologia Medica
City
Negrar
State/Province
Verona
ZIP/Postal Code
37024
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
STEFANIA GORI, Md
Facility Name
Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico U.O. Oncologia Medica e Sperimentale
City
Bari
ZIP/Postal Code
70124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GIUSEPPE COLUCCI, Md
Facility Name
Azienda Ospedaliera G. Rummo U.O. di Oncologia Medica
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
BRUNO DANIELE, Md
Facility Name
Ospedale Fatebenefratelli 'Sacro Cuore di Gesù' U.O. Oncologia
City
Benevento
ZIP/Postal Code
82100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO FEBBRARO, Md
Facility Name
Presidio Ospedaliero 'Antonio Perrino' U.O.C. di Oncologia
City
Brindisi
ZIP/Postal Code
72100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SAVERIO CINIERI, Md
Facility Name
dazione di Ricerca e Cura 'Giovanni Paolo II' U.O. di Ginecologia Oncologia
City
Campobasso
ZIP/Postal Code
86100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GABRIELLA MARIA FERRANDINA, Md
Facility Name
Ospedale Civile di Campobasso - A. Cardarelli U.O.C. Oncologia Medica
City
Campobasso
ZIP/Postal Code
86100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCESCO CARROZZA, Md
Facility Name
Azienda Ospedaliera 'Sant'Anna e San Sebastiano' U.O.C. di Oncologia
City
Caserta
ZIP/Postal Code
81100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LUIGI DE LUCIA, Md
Facility Name
Presidio Ospedaliero Garibaldi - Nesima S.C. di Oncologia Medica
City
Catania
ZIP/Postal Code
95122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROBERTO BORDONARO, Md
Facility Name
A.O.U. Ospedale Vittorio Emanuele e Ferrarotto U.O. di Oncologia Medica
City
Catania
ZIP/Postal Code
95124
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CALOGERO BUSCARINO, Md
Facility Name
Humanitas Centro Catanese di Oncologia U.O. Oncologia Medica
City
Catania
ZIP/Postal Code
95126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MICHELE CARUSO, Md
Facility Name
Azienda Ospedaliera S. Anna U.O. di Oncologia Medica
City
Como
ZIP/Postal Code
22100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MONICA GIORDANO, Md
Facility Name
Arcispedaliera S. Anna di Ferrara U.O. Oncologia Clinica
City
Ferrara
ZIP/Postal Code
44121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MONICA INDELLI, Md
Facility Name
I.R.C.C.S. A.O.U. San Martino - I.S.T. S.C. Oncologia Medica A
City
Genova
ZIP/Postal Code
16132
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LUCIA DEL MASTRO, Md
Facility Name
ASRM - Ospedale F. Veneziale - Zona di Isernia U.O. Oncologia
City
Isernia
ZIP/Postal Code
86170
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LIBERATO DI LULLO, Md
Facility Name
A.S.L. LT - Ospedale Santa Maria Goretti U.O.C. di Oncologia Medica
City
Latina
ZIP/Postal Code
04100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ENZO VELTRI, Md
Facility Name
Ospedale Vito Fazzi U.O. di Oncologia
City
Lecce
ZIP/Postal Code
73100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ROSACHIARA FORCIGNANÒ, Md
Facility Name
Istituto Europeo di Oncologia (IRCCS) Dipartimento di Medicina - Unità Cure Mediche
City
Milano
ZIP/Postal Code
20141
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCO NOLÈ, Md
Facility Name
Azienda Ospedaliera Cardarelli Divisione Di Oncologia
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GIACOMO CARTENÌ, Md
Facility Name
Istituto Nazionale dei Tumori - Fondazione G. Pascale U.O. Oncologia Medica Senologica
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MICHELINO DE LAURENTIIS, Md
Facility Name
Università di Napoli Federico II - Facoltà di Medicina Dipartimento di Medicina Clinica e Chirurgia - Oncologia
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SABINO DE PLACIDO, Md
Facility Name
A.O.U. 'Maggiore della Carità' S.C. Oncologia
City
Novara
ZIP/Postal Code
28100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Oscar Alabisio, MD
Facility Name
Istituto Oncologico Veneto - I.R.C.C.S. U.O. di Oncologia Medica II
City
Padova
ZIP/Postal Code
35128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO JIRILLO, Md
Facility Name
A.O.U.P. 'Paolo Giaccone' U.O.C. di Oncologia Medica
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO RUSSO, Md
Facility Name
A.R.N.A.S - Ospedale Civico e Benfratelli G. Di Cristina e M. Ascoli Divisione di Oncologia Medica
City
Palermo
ZIP/Postal Code
90127
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
VITA LEONARDI, Md
Facility Name
Fondazione S. Maugeri IRCCS U.O. Oncologia Medica II
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO BERNARDO, Md
Facility Name
IRCCS Policlinico S. Matteo S.C. di Oncologia Medica
City
Pavia
ZIP/Postal Code
27100
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
Ospedale S. Maria della Misericordia S.C. Oncologia Medica
City
Perugia
ZIP/Postal Code
06122
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CARLO BASURTO, Md
Facility Name
AUSL di Piacenza - Ospedale U.O. Oncologia Medica
City
Piacenza
ZIP/Postal Code
29121
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LUIGI CAVANNA, Md
Facility Name
Azienda Ospedaliera Santa Maria degli Angeli U.O. Oncolgia Medica
City
Pordenone
ZIP/Postal Code
33170
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
SILVANA SARACCHINI, Md
Facility Name
Azienda Ospedaliera Bianchi - Melacrino - Morelli U.O. di Oncologia Medica
City
Reggio Calabria
ZIP/Postal Code
89125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIO NARDI, Md
Facility Name
Arcispedale S.Maria Nuova Servizio di Oncologia
City
Reggio Emilia
ZIP/Postal Code
42123
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CORRADO BONI, Md
Facility Name
Istituto Regina Elena per lo studio e la cura dei tumori S.C. Oncologia Medica A
City
Roma
ZIP/Postal Code
00144
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FRANCESCO COGNETTI, mD
Facility Name
Azienda Ospedaliera San Camillo - Forlanini Day Hospital Oncologia Mammella
City
Roma
ZIP/Postal Code
00149
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANNA MARIA PARISI, Md
Facility Name
Policlinico Universitario 'Agostino Gemelli' U.O.C. Ginecologia Oncologica
City
Roma
ZIP/Postal Code
00168
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GIOVANNI SCAMBIA, Md
Facility Name
Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina U.O. Oncologia
City
Roma
ZIP/Postal Code
00186
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANGELO FEDELE SCINTO, Md
Facility Name
Azienda Ospedaliera S. Andrea - Università La Sapienza U.O.C. Oncologia
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
PAOLO MARCHETTI, Md
Facility Name
Ospedale San Pietro Fatebenefratelli Dipartimento di Oncologia - Day Hospital Oncologico
City
Roma
ZIP/Postal Code
00189
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
IDA PAVESE, Md
Facility Name
Ospedale G. Da Procida - ASL SA U.O. di Oncologia
City
Salerno
ZIP/Postal Code
84126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIA LUISA BARZELLONI, Md
Facility Name
Azienda Ospedaliera 'San Giovanni di Dio e Ruggi D'Aragona' Struttura Complessa di Oncologia
City
Salerno
ZIP/Postal Code
84131
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
CLEMENTINA SAVASTANO, Md
Facility Name
Azienda Ospedaliera n. 1 - Annunziata Oncologia Medica
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO CONTU, Md
Facility Name
Università di Sassari U.O. di Oncologia Medica
City
Sassari
ZIP/Postal Code
07100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
MARIA GIUSEPPA SAROBBA, Md
Facility Name
Ospedale Civile di Sondrio - Azienda Ospedaliera Valtellina e Valchiavenna S.C. Oncologia Medica
City
Sondrio
ZIP/Postal Code
23100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ALESSANDRO BERTOLINI, Md
Facility Name
Ospedale Evangelico Valdese - ASL TO1 U.O. di Oncologia Medica
City
Torino
ZIP/Postal Code
10125
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANNA TURLETTI, Md
Facility Name
Presidio San Lazzaro - A.O.U. San Giovanni Battista di Torino (Molinette) S.C. Oncologia Medica II
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mario Airoldi, MD
Facility Name
Università degli Studi di Torino - Ospedale S. Anna U.O. di Oncologia Medica
City
Torino
ZIP/Postal Code
10126
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
ANTONIO DURANDO, Md
Facility Name
Ospedale Mauriziano Umberto I S.C.D.U. Ginecologia e Ostetricia
City
Torino
ZIP/Postal Code
10128
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
NICOLETTA BIGLIA, Md
Facility Name
Centro Oncologico A.S.S. N°1 Triestina Centro Sociale Oncologico
City
Trieste
ZIP/Postal Code
34147
Country
Italy
Individual Site Status
Active, not recruiting
Facility Name
A.O.U. ´S. Maria della Misericordia´ Dipartimento di Oncologia
City
Udine
ZIP/Postal Code
33100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
FABIO PUGLISI, Md
Facility Name
Azienda Ospedaliera Circolo e Fondazione Macchi U.O. di Oncologia Medica
City
Varese
ZIP/Postal Code
21100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
GRAZIELLA PINOTTI, Md
Facility Name
Presidio Ospedaliero 'Belcolle' U.O.C. Oncologia Medica
City
Viterbo
ZIP/Postal Code
01100
Country
Italy
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
LUCA MOSCETTI, Md

12. IPD Sharing Statement

Citations:
PubMed Identifier
10977847
Citation
McPherson K, Steel CM, Dixon JM. ABC of breast diseases. Breast cancer-epidemiology, risk factors, and genetics. BMJ. 2000 Sep 9;321(7261):624-8. doi: 10.1136/bmj.321.7261.624. No abstract available.
Results Reference
background
PubMed Identifier
11181655
Citation
Fisher B, Anderson S, Tan-Chiu E, Wolmark N, Wickerham DL, Fisher ER, Dimitrov NV, Atkins JN, Abramson N, Merajver S, Romond EH, Kardinal CG, Shibata HR, Margolese RG, Farrar WB. Tamoxifen and chemotherapy for axillary node-negative, estrogen receptor-negative breast cancer: findings from National Surgical Adjuvant Breast and Bowel Project B-23. J Clin Oncol. 2001 Feb 15;19(4):931-42. doi: 10.1200/JCO.2001.19.4.931.
Results Reference
background
PubMed Identifier
11949754
Citation
Meric F, Hung MC, Hortobagyi GN, Hunt KK. HER2/neu in the management of invasive breast cancer. J Am Coll Surg. 2002 Apr;194(4):488-501. doi: 10.1016/s1072-7515(02)01121-3. No abstract available.
Results Reference
background
PubMed Identifier
11248153
Citation
Slamon DJ, Leyland-Jones B, Shak S, Fuchs H, Paton V, Bajamonde A, Fleming T, Eiermann W, Wolter J, Pegram M, Baselga J, Norton L. Use of chemotherapy plus a monoclonal antibody against HER2 for metastatic breast cancer that overexpresses HER2. N Engl J Med. 2001 Mar 15;344(11):783-92. doi: 10.1056/NEJM200103153441101.
Results Reference
background
PubMed Identifier
11597399
Citation
Nicholson RI, Gee JM, Harper ME. EGFR and cancer prognosis. Eur J Cancer. 2001 Sep;37 Suppl 4:S9-15. doi: 10.1016/s0959-8049(01)00231-3.
Results Reference
background
PubMed Identifier
11252954
Citation
Yarden Y, Sliwkowski MX. Untangling the ErbB signalling network. Nat Rev Mol Cell Biol. 2001 Feb;2(2):127-37. doi: 10.1038/35052073.
Results Reference
background
PubMed Identifier
16236735
Citation
Burstein HJ. The distinctive nature of HER2-positive breast cancers. N Engl J Med. 2005 Oct 20;353(16):1652-4. doi: 10.1056/NEJMp058197. No abstract available.
Results Reference
background
PubMed Identifier
11752009
Citation
Lu Y, Zi X, Zhao Y, Mascarenhas D, Pollak M. Insulin-like growth factor-I receptor signaling and resistance to trastuzumab (Herceptin). J Natl Cancer Inst. 2001 Dec 19;93(24):1852-7. doi: 10.1093/jnci/93.24.1852.
Results Reference
background
PubMed Identifier
14737100
Citation
Xia W, Liu LH, Ho P, Spector NL. Truncated ErbB2 receptor (p95ErbB2) is regulated by heregulin through heterodimer formation with ErbB3 yet remains sensitive to the dual EGFR/ErbB2 kinase inhibitor GW572016. Oncogene. 2004 Jan 22;23(3):646-53. doi: 10.1038/sj.onc.1207166.
Results Reference
background
PubMed Identifier
12087404
Citation
Gerber HP, Malik AK, Solar GP, Sherman D, Liang XH, Meng G, Hong K, Marsters JC, Ferrara N. VEGF regulates haematopoietic stem cell survival by an internal autocrine loop mechanism. Nature. 2002 Jun 27;417(6892):954-8. doi: 10.1038/nature00821.
Results Reference
background
PubMed Identifier
11522647
Citation
Albanell J, Codony-Servat J, Rojo F, Del Campo JM, Sauleda S, Anido J, Raspall G, Giralt J, Rosello J, Nicholson RI, Mendelsohn J, Baselga J. Activated extracellular signal-regulated kinases: association with epidermal growth factor receptor/transforming growth factor alpha expression in head and neck squamous carcinoma and inhibition by anti-epidermal growth factor receptor treatments. Cancer Res. 2001 Sep 1;61(17):6500-10.
Results Reference
background
PubMed Identifier
9625170
Citation
Rubin Grandis J, Melhem MF, Gooding WE, Day R, Holst VA, Wagener MM, Drenning SD, Tweardy DJ. Levels of TGF-alpha and EGFR protein in head and neck squamous cell carcinoma and patient survival. J Natl Cancer Inst. 1998 Jun 3;90(11):824-32. doi: 10.1093/jnci/90.11.824.
Results Reference
background
PubMed Identifier
9535913
Citation
Howell GM, Humphrey LE, Awwad RA, Wang D, Koterba A, Periyasamy B, Yang J, Li W, Willson JK, Ziober BL, Coleman K, Carboni J, Lynch M, Brattain MG. Aberrant regulation of transforming growth factor-alpha during the establishment of growth arrest and quiescence of growth factor independent cells. J Biol Chem. 1998 Apr 10;273(15):9214-23. doi: 10.1074/jbc.273.15.9214.
Results Reference
background
PubMed Identifier
9813060
Citation
Jiang D, Yang H, Willson JK, Liang J, Humphrey LE, Zborowska E, Wang D, Foster J, Fan R, Brattain MG. Autocrine transforming growth factor alpha provides a growth advantage to malignant cells by facilitating re-entry into the cell cycle from suboptimal growth states. J Biol Chem. 1998 Nov 20;273(47):31471-9. doi: 10.1074/jbc.273.47.31471.
Results Reference
background
PubMed Identifier
11585755
Citation
Rusnak DW, Affleck K, Cockerill SG, Stubberfield C, Harris R, Page M, Smith KJ, Guntrip SB, Carter MC, Shaw RJ, Jowett A, Stables J, Topley P, Wood ER, Brignola PS, Kadwell SH, Reep BR, Mullin RJ, Alligood KJ, Keith BR, Crosby RM, Murray DM, Knight WB, Gilmer TM, Lackey K. The characterization of novel, dual ErbB-2/EGFR, tyrosine kinase inhibitors: potential therapy for cancer. Cancer Res. 2001 Oct 1;61(19):7196-203.
Results Reference
background
PubMed Identifier
11821453
Citation
Vogel CL, Cobleigh MA, Tripathy D, Gutheil JC, Harris LN, Fehrenbacher L, Slamon DJ, Murphy M, Novotny WF, Burchmore M, Shak S, Stewart SJ, Press M. Efficacy and safety of trastuzumab as a single agent in first-line treatment of HER2-overexpressing metastatic breast cancer. J Clin Oncol. 2002 Feb 1;20(3):719-26. doi: 10.1200/JCO.2002.20.3.719.
Results Reference
background
PubMed Identifier
14654531
Citation
Grossi PM, Ochiai H, Archer GE, McLendon RE, Zalutsky MR, Friedman AH, Friedman HS, Bigner DD, Sampson JH. Efficacy of intracerebral microinfusion of trastuzumab in an athymic rat model of intracerebral metastatic breast cancer. Clin Cancer Res. 2003 Nov 15;9(15):5514-20.
Results Reference
background
PubMed Identifier
10829059
Citation
Pestalozzi BC, Brignoli S. Trastuzumab in CSF. J Clin Oncol. 2000 Jun;18(11):2349-51. doi: 10.1200/JCO.2000.18.11.2349. No abstract available.
Results Reference
background
PubMed Identifier
10561337
Citation
Cobleigh MA, Vogel CL, Tripathy D, Robert NJ, Scholl S, Fehrenbacher L, Wolter JM, Paton V, Shak S, Lieberman G, Slamon DJ. Multinational study of the efficacy and safety of humanized anti-HER2 monoclonal antibody in women who have HER2-overexpressing metastatic breast cancer that has progressed after chemotherapy for metastatic disease. J Clin Oncol. 1999 Sep;17(9):2639-48. doi: 10.1200/JCO.1999.17.9.2639.
Results Reference
background
PubMed Identifier
11352965
Citation
Burstein HJ, Kuter I, Campos SM, Gelman RS, Tribou L, Parker LM, Manola J, Younger J, Matulonis U, Bunnell CA, Partridge AH, Richardson PG, Clarke K, Shulman LN, Winer EP. Clinical activity of trastuzumab and vinorelbine in women with HER2-overexpressing metastatic breast cancer. J Clin Oncol. 2001 May 15;19(10):2722-30. doi: 10.1200/JCO.2001.19.10.2722.
Results Reference
background
PubMed Identifier
12784331
Citation
Bendell JC, Domchek SM, Burstein HJ, Harris L, Younger J, Kuter I, Bunnell C, Rue M, Gelman R, Winer E. Central nervous system metastases in women who receive trastuzumab-based therapy for metastatic breast carcinoma. Cancer. 2003 Jun 15;97(12):2972-7. doi: 10.1002/cncr.11436.
Results Reference
background
PubMed Identifier
15266327
Citation
Clayton AJ, Danson S, Jolly S, Ryder WD, Burt PA, Stewart AL, Wilkinson PM, Welch RS, Magee B, Wilson G, Howell A, Wardley AM. Incidence of cerebral metastases in patients treated with trastuzumab for metastatic breast cancer. Br J Cancer. 2004 Aug 16;91(4):639-43. doi: 10.1038/sj.bjc.6601970.
Results Reference
background
PubMed Identifier
9747868
Citation
Fisher B, Costantino JP, Wickerham DL, Redmond CK, Kavanah M, Cronin WM, Vogel V, Robidoux A, Dimitrov N, Atkins J, Daly M, Wieand S, Tan-Chiu E, Ford L, Wolmark N. Tamoxifen for prevention of breast cancer: report of the National Surgical Adjuvant Breast and Bowel Project P-1 Study. J Natl Cancer Inst. 1998 Sep 16;90(18):1371-88. doi: 10.1093/jnci/90.18.1371.
Results Reference
background
PubMed Identifier
8251648
Citation
Encarnacion CA, Ciocca DR, McGuire WL, Clark GM, Fuqua SA, Osborne CK. Measurement of steroid hormone receptors in breast cancer patients on tamoxifen. Breast Cancer Res Treat. 1993;26(3):237-46. doi: 10.1007/BF00665801.
Results Reference
background
PubMed Identifier
6847780
Citation
Hull DF 3rd, Clark GM, Osborne CK, Chamness GC, Knight WA 3rd, McGuire WL. Multiple estrogen receptor assays in human breast cancer. Cancer Res. 1983 Jan;43(1):413-6.
Results Reference
background
PubMed Identifier
9740079
Citation
Buzdar AU, Jonat W, Howell A, Jones SE, Blomqvist CP, Vogel CL, Eiermann W, Wolter JM, Steinberg M, Webster A, Lee D. Anastrozole versus megestrol acetate in the treatment of postmenopausal women with advanced breast carcinoma: results of a survival update based on a combined analysis of data from two mature phase III trials. Arimidex Study Group. Cancer. 1998 Sep 15;83(6):1142-52. Erratum In: Cancer 1999 Feb 15;85(4):1010.
Results Reference
background
PubMed Identifier
11454883
Citation
Buzdar A, Douma J, Davidson N, Elledge R, Morgan M, Smith R, Porter L, Nabholtz J, Xiang X, Brady C. Phase III, multicenter, double-blind, randomized study of letrozole, an aromatase inhibitor, for advanced breast cancer versus megestrol acetate. J Clin Oncol. 2001 Jul 15;19(14):3357-66. doi: 10.1200/JCO.2001.19.14.3357.
Results Reference
background
PubMed Identifier
9469328
Citation
Dombernowsky P, Smith I, Falkson G, Leonard R, Panasci L, Bellmunt J, Bezwoda W, Gardin G, Gudgeon A, Morgan M, Fornasiero A, Hoffmann W, Michel J, Hatschek T, Tjabbes T, Chaudri HA, Hornberger U, Trunet PF. Letrozole, a new oral aromatase inhibitor for advanced breast cancer: double-blind randomized trial showing a dose effect and improved efficacy and tolerability compared with megestrol acetate. J Clin Oncol. 1998 Feb;16(2):453-61. doi: 10.1200/JCO.1998.16.2.453.
Results Reference
background
PubMed Identifier
11745278
Citation
Bonneterre J, Buzdar A, Nabholtz JM, Robertson JF, Thurlimann B, von Euler M, Sahmoud T, Webster A, Steinberg M; Arimidex Writing Committee; Investigators Committee Members. Anastrozole is superior to tamoxifen as first-line therapy in hormone receptor positive advanced breast carcinoma. Cancer. 2001 Nov 1;92(9):2247-58. doi: 10.1002/1097-0142(20011101)92:93.0.co;2-y.
Results Reference
background
PubMed Identifier
11352951
Citation
Mouridsen H, Gershanovich M, Sun Y, Perez-Carrion R, Boni C, Monnier A, Apffelstaedt J, Smith R, Sleeboom HP, Janicke F, Pluzanska A, Dank M, Becquart D, Bapsy PP, Salminen E, Snyder R, Lassus M, Verbeek JA, Staffler B, Chaudri-Ross HA, Dugan M. Superior efficacy of letrozole versus tamoxifen as first-line therapy for postmenopausal women with advanced breast cancer: results of a phase III study of the International Letrozole Breast Cancer Group. J Clin Oncol. 2001 May 15;19(10):2596-606. doi: 10.1200/JCO.2001.19.10.2596. Erratum In: J Clin Oncol 2001 Jul 1;19(13):3302.
Results Reference
background
PubMed Identifier
12177099
Citation
Howell A, Robertson JF, Quaresma Albano J, Aschermannova A, Mauriac L, Kleeberg UR, Vergote I, Erikstein B, Webster A, Morris C. Fulvestrant, formerly ICI 182,780, is as effective as anastrozole in postmenopausal women with advanced breast cancer progressing after prior endocrine treatment. J Clin Oncol. 2002 Aug 15;20(16):3396-403. doi: 10.1200/JCO.2002.10.057.
Results Reference
background
PubMed Identifier
12177098
Citation
Osborne CK, Pippen J, Jones SE, Parker LM, Ellis M, Come S, Gertler SZ, May JT, Burton G, Dimery I, Webster A, Morris C, Elledge R, Buzdar A. Double-blind, randomized trial comparing the efficacy and tolerability of fulvestrant versus anastrozole in postmenopausal women with advanced breast cancer progressing on prior endocrine therapy: results of a North American trial. J Clin Oncol. 2002 Aug 15;20(16):3386-95. doi: 10.1200/JCO.2002.10.058.
Results Reference
background
PubMed Identifier
10951345
Citation
Howell A, Osborne CK, Morris C, Wakeling AE. ICI 182,780 (Faslodex): development of a novel, "pure" antiestrogen. Cancer. 2000 Aug 15;89(4):817-25. doi: 10.1002/1097-0142(20000815)89:43.0.co;2-6. Erratum In: Cancer 2001 Jan 15;91(2):455.
Results Reference
background
PubMed Identifier
11559545
Citation
Robertson JF, Nicholson RI, Bundred NJ, Anderson E, Rayter Z, Dowsett M, Fox JN, Gee JM, Webster A, Wakeling AE, Morris C, Dixon M. Comparison of the short-term biological effects of 7alpha-[9-(4,4,5,5,5-pentafluoropentylsulfinyl)-nonyl]estra-1,3,5, (10)-triene-3,17beta-diol (Faslodex) versus tamoxifen in postmenopausal women with primary breast cancer. Cancer Res. 2001 Sep 15;61(18):6739-46.
Results Reference
background
PubMed Identifier
1855205
Citation
Wakeling AE, Dukes M, Bowler J. A potent specific pure antiestrogen with clinical potential. Cancer Res. 1991 Aug 1;51(15):3867-73.
Results Reference
background
PubMed Identifier
12763210
Citation
Mauriac L, Pippen JE, Quaresma Albano J, Gertler SZ, Osborne CK. Fulvestrant (Faslodex) versus anastrozole for the second-line treatment of advanced breast cancer in subgroups of postmenopausal women with visceral and non-visceral metastases: combined results from two multicentre trials. Eur J Cancer. 2003 Jun;39(9):1228-33. doi: 10.1016/s0959-8049(03)00199-0.
Results Reference
background
PubMed Identifier
12454761
Citation
Addo S, Yates RA, Laight A. A phase I trial to assess the pharmacology of the new oestrogen receptor antagonist fulvestrant on the endometrium in healthy postmenopausal volunteers. Br J Cancer. 2002 Dec 2;87(12):1354-9. doi: 10.1038/sj.bjc.6600644.
Results Reference
background
PubMed Identifier
8054267
Citation
DeFriend DJ, Anderson E, Bell J, Wilks DP, West CM, Mansel RE, Howell A. Effects of 4-hydroxytamoxifen and a novel pure antioestrogen (ICI 182780) on the clonogenic growth of human breast cancer cells in vitro. Br J Cancer. 1994 Aug;70(2):204-11. doi: 10.1038/bjc.1994.281.
Results Reference
background
PubMed Identifier
15814851
Citation
Brueggemeier RW, Hackett JC, Diaz-Cruz ES. Aromatase inhibitors in the treatment of breast cancer. Endocr Rev. 2005 May;26(3):331-45. doi: 10.1210/er.2004-0015. Epub 2005 Apr 6.
Results Reference
background
PubMed Identifier
14551341
Citation
Goss PE, Ingle JN, Martino S, Robert NJ, Muss HB, Piccart MJ, Castiglione M, Tu D, Shepherd LE, Pritchard KI, Livingston RB, Davidson NE, Norton L, Perez EA, Abrams JS, Therasse P, Palmer MJ, Pater JL. A randomized trial of letrozole in postmenopausal women after five years of tamoxifen therapy for early-stage breast cancer. N Engl J Med. 2003 Nov 6;349(19):1793-802. doi: 10.1056/NEJMoa032312. Epub 2003 Oct 9.
Results Reference
background
PubMed Identifier
15014181
Citation
Coombes RC, Hall E, Gibson LJ, Paridaens R, Jassem J, Delozier T, Jones SE, Alvarez I, Bertelli G, Ortmann O, Coates AS, Bajetta E, Dodwell D, Coleman RE, Fallowfield LJ, Mickiewicz E, Andersen J, Lonning PE, Cocconi G, Stewart A, Stuart N, Snowdon CF, Carpentieri M, Massimini G, Bliss JM, van de Velde C; Intergroup Exemestane Study. A randomized trial of exemestane after two to three years of tamoxifen therapy in postmenopausal women with primary breast cancer. N Engl J Med. 2004 Mar 11;350(11):1081-92. doi: 10.1056/NEJMoa040331. Erratum In: N Engl J Med. 2004 Dec 2;351(23):2461. N Engl J Med. 2006 Oct 19;355(16):1746. van de Velde, Cornelius [added].
Results Reference
background
PubMed Identifier
15639680
Citation
Howell A, Cuzick J, Baum M, Buzdar A, Dowsett M, Forbes JF, Hoctin-Boes G, Houghton J, Locker GY, Tobias JS; ATAC Trialists' Group. Results of the ATAC (Arimidex, Tamoxifen, Alone or in Combination) trial after completion of 5 years' adjuvant treatment for breast cancer. Lancet. 2005 Jan 1-7;365(9453):60-2. doi: 10.1016/S0140-6736(04)17666-6.
Results Reference
background
PubMed Identifier
8758911
Citation
Kao YC, Cam LL, Laughton CA, Zhou D, Chen S. Binding characteristics of seven inhibitors of human aromatase: a site-directed mutagenesis study. Cancer Res. 1996 Aug 1;56(15):3451-60.
Results Reference
background
PubMed Identifier
14668813
Citation
Johnston SR, Dowsett M. Aromatase inhibitors for breast cancer: lessons from the laboratory. Nat Rev Cancer. 2003 Nov;3(11):821-31. doi: 10.1038/nrc1211. No abstract available.
Results Reference
background
PubMed Identifier
7893351
Citation
Sourdaine P, Parker MG, Telford J, Miller WR. Analysis of the aromatase cytochrome P450 gene in human breast cancers. J Mol Endocrinol. 1994 Dec;13(3):331-7. doi: 10.1677/jme.0.0130331.
Results Reference
background
PubMed Identifier
14687595
Citation
Miller WR. Biological rationale for endocrine therapy in breast cancer. Best Pract Res Clin Endocrinol Metab. 2004 Mar;18(1):1-32. doi: 10.1016/s1521-690x(03)00044-7.
Results Reference
background
PubMed Identifier
9751496
Citation
Jeng MH, Shupnik MA, Bender TP, Westin EH, Bandyopadhyay D, Kumar R, Masamura S, Santen RJ. Estrogen receptor expression and function in long-term estrogen-deprived human breast cancer cells. Endocrinology. 1998 Oct;139(10):4164-74. doi: 10.1210/endo.139.10.6229.
Results Reference
background
PubMed Identifier
10614662
Citation
Shim WS, Conaway M, Masamura S, Yue W, Wang JP, Kmar R, Santen RJ. Estradiol hypersensitivity and mitogen-activated protein kinase expression in long-term estrogen deprived human breast cancer cells in vivo. Endocrinology. 2000 Jan;141(1):396-405. doi: 10.1210/endo.141.1.7270.
Results Reference
background
PubMed Identifier
12361723
Citation
Chan CM, Martin LA, Johnston SR, Ali S, Dowsett M. Molecular changes associated with the acquisition of oestrogen hypersensitivity in MCF-7 breast cancer cells on long-term oestrogen deprivation. J Steroid Biochem Mol Biol. 2002 Aug;81(4-5):333-41. doi: 10.1016/s0960-0760(02)00074-2.
Results Reference
background
PubMed Identifier
12775708
Citation
Martin LA, Farmer I, Johnston SR, Ali S, Marshall C, Dowsett M. Enhanced estrogen receptor (ER) alpha, ERBB2, and MAPK signal transduction pathways operate during the adaptation of MCF-7 cells to long term estrogen deprivation. J Biol Chem. 2003 Aug 15;278(33):30458-68. doi: 10.1074/jbc.M305226200. Epub 2003 May 29.
Results Reference
background
PubMed Identifier
16024245
Citation
Santen RJ, Song RX, Zhang Z, Kumar R, Jeng MH, Masamura S, Lawrence J Jr, MacMahon LP, Yue W, Berstein L. Adaptive hypersensitivity to estrogen: mechanisms and clinical relevance to aromatase inhibitor therapy in breast cancer treatment. J Steroid Biochem Mol Biol. 2005 May;95(1-5):155-65. doi: 10.1016/j.jsbmb.2005.04.025.
Results Reference
background
PubMed Identifier
8645630
Citation
Borras M, Laios I, el Khissiin A, Seo HS, Lempereur F, Legros N, Leclercq G. Estrogenic and antiestrogenic regulation of the half-life of covalently labeled estrogen receptor in MCF-7 breast cancer cells. J Steroid Biochem Mol Biol. 1996 Feb;57(3-4):203-13. doi: 10.1016/0960-0760(95)00272-3.
Results Reference
background
PubMed Identifier
8126115
Citation
Dauvois S, White R, Parker MG. The antiestrogen ICI 182780 disrupts estrogen receptor nucleocytoplasmic shuttling. J Cell Sci. 1993 Dec;106 ( Pt 4):1377-88. doi: 10.1242/jcs.106.4.1377.
Results Reference
background
PubMed Identifier
16505423
Citation
Ingle JN, Suman VJ, Rowland KM, Mirchandani D, Bernath AM, Camoriano JK, Fishkin PA, Nikcevich DA, Perez EA; North Central Cancer Treatment Group Trial N0032. Fulvestrant in women with advanced breast cancer after progression on prior aromatase inhibitor therapy: North Central Cancer Treatment Group Trial N0032. J Clin Oncol. 2006 Mar 1;24(7):1052-6. doi: 10.1200/JCO.2005.04.1053.
Results Reference
background
PubMed Identifier
17030543
Citation
Perey L, Paridaens R, Hawle H, Zaman K, Nole F, Wildiers H, Fiche M, Dietrich D, Clement P, Koberle D, Goldhirsch A, Thurlimann B. Clinical benefit of fulvestrant in postmenopausal women with advanced breast cancer and primary or acquired resistance to aromatase inhibitors: final results of phase II Swiss Group for Clinical Cancer Research Trial (SAKK 21/00). Ann Oncol. 2007 Jan;18(1):64-69. doi: 10.1093/annonc/mdl341. Epub 2006 Oct 9.
Results Reference
background
PubMed Identifier
15865847
Citation
Gradishar WJ, Sahmoud T. Current and future perspectives on fulvestrant. Clin Breast Cancer. 2005 Apr;6 Suppl 1:S23-9. doi: 10.3816/cbc.2005.s.011.
Results Reference
background
PubMed Identifier
11415996
Citation
McClelland RA, Barrow D, Madden TA, Dutkowski CM, Pamment J, Knowlden JM, Gee JM, Nicholson RI. Enhanced epidermal growth factor receptor signaling in MCF7 breast cancer cells after long-term culture in the presence of the pure antiestrogen ICI 182,780 (Faslodex). Endocrinology. 2001 Jul;142(7):2776-88. doi: 10.1210/endo.142.7.8259.
Results Reference
background
PubMed Identifier
11378364
Citation
Cockerill S, Stubberfield C, Stables J, Carter M, Guntrip S, Smith K, McKeown S, Shaw R, Topley P, Thomsen L, Affleck K, Jowett A, Hayes D, Willson M, Woollard P, Spalding D. Indazolylamino quinazolines and pyridopyrimidines as inhibitors of the EGFr and C-erbB-2. Bioorg Med Chem Lett. 2001 Jun 4;11(11):1401-5. doi: 10.1016/s0960-894x(01)00219-0.
Results Reference
background
PubMed Identifier
12214266
Citation
Xia W, Mullin RJ, Keith BR, Liu LH, Ma H, Rusnak DW, Owens G, Alligood KJ, Spector NL. Anti-tumor activity of GW572016: a dual tyrosine kinase inhibitor blocks EGF activation of EGFR/erbB2 and downstream Erk1/2 and AKT pathways. Oncogene. 2002 Sep 12;21(41):6255-63. doi: 10.1038/sj.onc.1205794.
Results Reference
background
PubMed Identifier
12467226
Citation
Rusnak DW, Lackey K, Affleck K, Wood ER, Alligood KJ, Rhodes N, Keith BR, Murray DM, Knight WB, Mullin RJ, Gilmer TM. The effects of the novel, reversible epidermal growth factor receptor/ErbB-2 tyrosine kinase inhibitor, GW2016, on the growth of human normal and tumor-derived cell lines in vitro and in vivo. Mol Cancer Ther. 2001 Dec;1(2):85-94.
Results Reference
background
PubMed Identifier
12853564
Citation
Holbro T, Beerli RR, Maurer F, Koziczak M, Barbas CF 3rd, Hynes NE. The ErbB2/ErbB3 heterodimer functions as an oncogenic unit: ErbB2 requires ErbB3 to drive breast tumor cell proliferation. Proc Natl Acad Sci U S A. 2003 Jul 22;100(15):8933-8. doi: 10.1073/pnas.1537685100. Epub 2003 Jul 9.
Results Reference
background

Learn more about this trial

Overcoming Endocrine Resistance in Metastatic Breast Cancer

We'll reach out to this number within 24 hrs