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CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer (GIM10-CONSENT)

Primary Purpose

Breast Cancer

Status
Active
Phase
Phase 3
Locations
Italy
Study Type
Interventional
Intervention
Anastrozole or Letrozole or Exemestane
Anastrozole or Letrozole or Exemestane
Sponsored by
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring sequential administration chemiotherapy, early breast cancer, breast cancer, aromatase inhibitor, adjuvant, post menopausal

Eligibility Criteria

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

Inclusion Criteria:

  • Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N.

  • Postmenopausal status defined by at least one of the following conditions:

    1. Aged ≥ 60

    2. Aged 45-59 and satisfying one or more of the following criteria:

      • amenorrhea for ≥12 months and intact uterus;

      • amenorrhea for <12 months and follicle-stimulating hormone (FSH) within the postmenopausal range, including:

        • pts with hysterectomy
        • pts who have received hormone replacement therapy (HRT)
        • pts with chemotherapy-induced amenorrhea
    3. bilateral oophorectomy at any age >18 years.
  • Primary tumor positive for Estrogen Receptors (ER) and/or Progesteron receptors (PgR) (≥1% tumor cells positive by immunohistochemistry or ≥ 10 fmol/mg cytosol protein by ligand binding assay).
  • Patients who are prescribed 5 years of endocrine therapy with an aromatase inhibitors (AI)
  • Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed trastuzumab according to registered schedule.
  • Signed informed consent.

Exclusion Criteria:

  • HRT currently assumed or during the month before randomization
  • Recurrent or metastatic disease
  • HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible
  • Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy
  • Patients who have received Tamoxifen as part of any breast cancer prevention trial
  • Previous history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied
  • Concomitant severe disease which would place the patient at unusual risk
  • Concurrent treatment with experimental drugs
  • Patients treated with systemic investigational drugs within the past 30 days

Sites / Locations

  • Ospedale Santo SpiritoH
  • Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2
  • A.O. San Giuseppe Moscati
  • Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico
  • ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
  • Azienda Ospedaliera Treviglio-Caravaggio
  • Azienda Ospedaliera G. Rummo
  • Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'
  • Presidio Ospedaliero 'Antonio Perrino'
  • ASST Spedali Civili - P.O. Spedali Civili
  • Ospedale Civile di Campobasso - A. Cardarelli
  • Ospedale Vietri
  • Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio'
  • Ospedale Civile Renzetti
  • Ospedale Civile 'Gaetano Bernabeo'
  • Azienda Ospedaliera S. Croce e Carle
  • ASST Lariana - Ospedale S. Anna
  • Humanitas Centro Catanese di Oncologia
  • IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
  • Arcispedale S. Anna - A.O.U. di Ferrara
  • IRCCS 'Casa Sollievo della Sofferenza'
  • A.O.U. Careggi
  • AUSL di Frosinone - Ospedale Fabrizio Spaziani
  • AUSL di Frosinone - Ospedale SS. Trinità
  • IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
  • E.O. Ospedali Galliera
  • Azienda U.S.L. N. 9 - Ospedale Misericordia
  • Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia
  • Ospedale Vito Fazzi
  • A.S.L. LT - Ospedale Santa Maria Goretti
  • Ospedale Unico Versilia
  • Ospedale San Luca
  • ASST Monza - Ospedale San Gerardo
  • Ospedale di Macerata
  • ASST Melegnano e della Martesana - Ospedale Serbelloni
  • ASST Ovest Milanese - Ospedale Nuovo di Legnano
  • ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico
  • Istituto Europeo di Oncologia (IRCCS)
  • Azienda Ospedaliera Carlo Poma
  • A.O.U. Policlinico Modena
  • A.O.U. Policlinico 'Paolo Giaccone'
  • Ospedale 'Guglielmo da Saliceto'
  • Istituto Oncologico Veneto - I.R.C.C.S.
  • Ospedale Civile 'San Massimo'
  • Ospedale Civile di Città di Castello - A.S.L. n. 1
  • Ospedale S. Maria della Misericordia
  • A.O.U. Pisana - Ospedale Santa Chiara
  • Ospedale Felice Lotti - Azienda USL 5 di Pisa
  • Policlinico Umberto I
  • Azienda Ospedaliera Universitaria di Parma
  • Ospedale Santa Croce - A.O. Ospedali Riuniti Marche Nord
  • Fondazione S. Maugeri IRCCS
  • Azienda Ospedaliera S. Carlo
  • Ospedale per gli Infermi
  • Ospedale Umberto I
  • Azienda Ospedaliera Bianchi - Melacrino - Morelli
  • Ospedale San Sebastiano
  • Ospedale Civile di Guastalla
  • IRCCS A.O. S.Maria Nuova
  • Istituto Regina Elena per lo studio e la cura dei tumori
  • Ospedale S. Eugenio
  • Azienda Ospedaliera San Camillo - Forlanini
  • Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina
  • A.O. S. Andrea - Università 'La Sapienza' - II Facoltà di Medicina e Chirurgia
  • Azienda Ospedaliera n. 1 - Annunziata
  • Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
  • Ospedale S. Anna - A.O.U. Città della Salute e della Scienza
  • Ospedale S. Anna - Città della salute
  • ASST della Valle Olona - Ospedale di Saronno
  • Ospedale Sacro Cuore Don Calabria
  • Ospedale Belcolle - AUSL di Viterbo
  • A.O.U. Federico II
  • Azienda Ospedaliera 'A. Cardarelli' (AORN)
  • Istituto Nazionale dei Tumori - Fondazione G.Pascale

Arms of the Study

Arm 1

Arm 2

Arm Type

Sham Comparator

Experimental

Arm Label

ARM A

ARM B

Arm Description

Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)

Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)

Outcomes

Primary Outcome Measures

Disease- free Survival (DFS)
the primary outcome indicator will be the so called DFS, defined as time elapsing between the date of randomization and the date of one of the following events, whichever occurs first, assessed up to 15 years: Local Recurrence of disease Regional recurrence of disease Distant recurrence of disease Contralateral invasive or intraductal breast cancer Second primary malignancy other than breast Death for any cause

Secondary Outcome Measures

Overall Survival (OS)
Translational Study: genomic analysis
Expression of genes associated with ER and Ki67 expression will be analyzed by Real Time polymerase chain reaction (PCR) on RNA extracted from formalin-fixed paraffin embedded (FFPE) sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive) and will be correlated with disease free survival.
Translational Study: epigenetic analysis
miRNA expression analysis by real time PCR and DNA methylation analysis by pyrosequencing will be assessed on FFPE sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive)
Translational Study: proteomic analysis
The different proteomic profiles identified in FFPE sections of hormone receptors positive G2 tumors will be correlated with DFS

Full Information

First Posted
September 16, 2016
Last Updated
May 17, 2022
Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborators
Clinical Research Technology S.r.l.
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1. Study Identification

Unique Protocol Identification Number
NCT02918084
Brief Title
CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer
Acronym
GIM10-CONSENT
Official Title
A Phase III Study Comparing the Concurrent Versus the Sequential Administration of Chemotherapy and Aromatase Inhibitors, as Adjuvant Treatment of Post-menopausal Patients With Endocrine-responsive Early Breast Cancer.
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
June 2013 (undefined)
Primary Completion Date
June 2028 (Anticipated)
Study Completion Date
June 2028 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Collaborators
Clinical Research Technology S.r.l.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Breast cancer is the most common form of cancer among women. For patients candidated for adjuvant chemotherapy and endocrine therapy the optimal timing for their has not been clearly defined yet.
Detailed Description
Breast cancer is the most common form of cancer among women in North America, Europe and Latin America. Because nearly 80% of breast cancers are endocrine-responsive tumors, the majority of patients candidates for adjuvant chemotherapy (CT) are also candidates for endocrine therapy (ET). The optimal timing (i.e. concomitant vs sequential administration) for the integration of these two treatments has not been clearly defined yet. In patients with hormone receptor positive early stage breast cancer who are candidates to adjuvant chemotherapy and endocrine therapy, the optimal timing for the integration of these two treatment modalities has not been clearly defined yet.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
sequential administration chemiotherapy, early breast cancer, breast cancer, aromatase inhibitor, adjuvant, post menopausal

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1000 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
ARM A
Arm Type
Sham Comparator
Arm Description
Adjuvant chemotherapy → Aromatase inhibitors x 5 yrs (sequential arm)
Arm Title
ARM B
Arm Type
Experimental
Arm Description
Adjuvant chemotherapy + Aromatase inhibitors x 5 yrs (concurrent arm)
Intervention Type
Drug
Intervention Name(s)
Anastrozole or Letrozole or Exemestane
Other Intervention Name(s)
Clinical Practice
Intervention Description
Adjuvant chemotherapy → Anastrozole or Letrozole or Exemestane once a day for 5 years (sequential arm)
Intervention Type
Drug
Intervention Name(s)
Anastrozole or Letrozole or Exemestane
Other Intervention Name(s)
Experimental arm
Intervention Description
Adjuvant chemotherapy + Anastrozole or Letrozole or Exemestane once a day for 5 years (concurrent arm)
Primary Outcome Measure Information:
Title
Disease- free Survival (DFS)
Description
the primary outcome indicator will be the so called DFS, defined as time elapsing between the date of randomization and the date of one of the following events, whichever occurs first, assessed up to 15 years: Local Recurrence of disease Regional recurrence of disease Distant recurrence of disease Contralateral invasive or intraductal breast cancer Second primary malignancy other than breast Death for any cause
Time Frame
up to 15 years
Secondary Outcome Measure Information:
Title
Overall Survival (OS)
Time Frame
time between the date of randomization up to the date of death for any cause, assessed up to 15 years.
Title
Translational Study: genomic analysis
Description
Expression of genes associated with ER and Ki67 expression will be analyzed by Real Time polymerase chain reaction (PCR) on RNA extracted from formalin-fixed paraffin embedded (FFPE) sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive) and will be correlated with disease free survival.
Time Frame
up to 15 years
Title
Translational Study: epigenetic analysis
Description
miRNA expression analysis by real time PCR and DNA methylation analysis by pyrosequencing will be assessed on FFPE sections of tumors classified as intermediate risk by clinical and pathological variables (stage I-II, G2, hormone receptors positive)
Time Frame
up to 15 years
Title
Translational Study: proteomic analysis
Description
The different proteomic profiles identified in FFPE sections of hormone receptors positive G2 tumors will be correlated with DFS
Time Frame
up to 15 years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Women with histological diagnosis of invasive breast cancer completely removed by surgery, any T, any N. Postmenopausal status defined by at least one of the following conditions: Aged ≥ 60 Aged 45-59 and satisfying one or more of the following criteria: amenorrhea for ≥12 months and intact uterus; amenorrhea for <12 months and follicle-stimulating hormone (FSH) within the postmenopausal range, including: pts with hysterectomy pts who have received hormone replacement therapy (HRT) pts with chemotherapy-induced amenorrhea bilateral oophorectomy at any age >18 years. Primary tumor positive for Estrogen Receptors (ER) and/or Progesteron receptors (PgR) (≥1% tumor cells positive by immunohistochemistry or ≥ 10 fmol/mg cytosol protein by ligand binding assay). Patients who are prescribed 5 years of endocrine therapy with an aromatase inhibitors (AI) Indication for adjuvant chemotherapy- Patients with HER-2 positive tumors are eligible provided that they are prescribed trastuzumab according to registered schedule. Signed informed consent. Exclusion Criteria: HRT currently assumed or during the month before randomization Recurrent or metastatic disease HER-2 positive tumors if treatment with trastuzumab is considered not appropriate/feasible Concurrent illness that contraindicate adjuvant endocrine treatment and/or chemotherapy Patients who have received Tamoxifen as part of any breast cancer prevention trial Previous history of invasive breast cancer or other invasive malignancy within the previous 10 years, other than squamous or basal cell carcinoma of the skin or carcinoma in situ of the cervix, adequately cone biopsied Concomitant severe disease which would place the patient at unusual risk Concurrent treatment with experimental drugs Patients treated with systemic investigational drugs within the past 30 days
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Lucia Del Mastro, MD
Organizational Affiliation
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
Official's Role
Principal Investigator
Facility Information:
Facility Name
Ospedale Santo SpiritoH
City
Casale Monferrato
State/Province
AL
ZIP/Postal Code
15033
Country
Italy
Facility Name
Ospedale di Rete 'Engles Profili' - A.S.U.R. Area Vasta 2
City
Fabriano
State/Province
AN
ZIP/Postal Code
60044
Country
Italy
Facility Name
A.O. San Giuseppe Moscati
City
Avellino
State/Province
AV
ZIP/Postal Code
83100
Country
Italy
Facility Name
Istituto Tumori 'Giovanni Paolo II' - IRCCS Ospedale Oncologico
City
Bari
State/Province
BA
ZIP/Postal Code
70124
Country
Italy
Facility Name
ASST Papa Giovanni XXIII - Ospedale Papa Giovanni XXIII
City
Bergamo
State/Province
BG
ZIP/Postal Code
24127
Country
Italy
Facility Name
Azienda Ospedaliera Treviglio-Caravaggio
City
Treviglio
State/Province
BG
ZIP/Postal Code
24047
Country
Italy
Facility Name
Azienda Ospedaliera G. Rummo
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Ospedale Fatebenefratelli 'Sacro Cuore di Gesù'
City
Benevento
State/Province
BN
ZIP/Postal Code
82100
Country
Italy
Facility Name
Presidio Ospedaliero 'Antonio Perrino'
City
Brindisi
State/Province
BR
ZIP/Postal Code
72100
Country
Italy
Facility Name
ASST Spedali Civili - P.O. Spedali Civili
City
Brescia
State/Province
BS
ZIP/Postal Code
25123
Country
Italy
Facility Name
Ospedale Civile di Campobasso - A. Cardarelli
City
Campobasso
State/Province
CB
ZIP/Postal Code
86100
Country
Italy
Facility Name
Ospedale Vietri
City
Larino
State/Province
CB
ZIP/Postal Code
80035
Country
Italy
Facility Name
Ospedale Clinicizzato 'S. Annunziata' - Università degli Studi 'G. d'Annunzio'
City
Chieti
State/Province
CH
ZIP/Postal Code
66100
Country
Italy
Facility Name
Ospedale Civile Renzetti
City
Lanciano
State/Province
CH
ZIP/Postal Code
66034
Country
Italy
Facility Name
Ospedale Civile 'Gaetano Bernabeo'
City
Ortona
State/Province
CH
ZIP/Postal Code
66026
Country
Italy
Facility Name
Azienda Ospedaliera S. Croce e Carle
City
Cuneo
State/Province
CN
ZIP/Postal Code
12100
Country
Italy
Facility Name
ASST Lariana - Ospedale S. Anna
City
Como
State/Province
CO
ZIP/Postal Code
22100
Country
Italy
Facility Name
Humanitas Centro Catanese di Oncologia
City
Catania
State/Province
CT
ZIP/Postal Code
95126
Country
Italy
Facility Name
IRCCS Istituto Scientifico Romagnolo per lo Studio e la Cura dei Tumori (I.R.S.T.)
City
Meldola
State/Province
FC
ZIP/Postal Code
47014
Country
Italy
Facility Name
Arcispedale S. Anna - A.O.U. di Ferrara
City
Cona
State/Province
FE
ZIP/Postal Code
44124
Country
Italy
Facility Name
IRCCS 'Casa Sollievo della Sofferenza'
City
San Giovanni Rotondo
State/Province
FG
ZIP/Postal Code
71013
Country
Italy
Facility Name
A.O.U. Careggi
City
Firenze
State/Province
FI
ZIP/Postal Code
50134
Country
Italy
Facility Name
AUSL di Frosinone - Ospedale Fabrizio Spaziani
City
Frosinone
State/Province
FR
ZIP/Postal Code
03100
Country
Italy
Facility Name
AUSL di Frosinone - Ospedale SS. Trinità
City
Sora
State/Province
FR
ZIP/Postal Code
03039
Country
Italy
Facility Name
IRCCS Azienda Ospedaliera Universitaria San Martino - IST Istituto Nazionale per la Ricerca sul Cancro, Genoa, Italy
City
Genoa
State/Province
GE
ZIP/Postal Code
16132
Country
Italy
Facility Name
E.O. Ospedali Galliera
City
Genova
State/Province
GE
ZIP/Postal Code
16128
Country
Italy
Facility Name
Azienda U.S.L. N. 9 - Ospedale Misericordia
City
Grosseto
State/Province
GR
ZIP/Postal Code
58100
Country
Italy
Facility Name
Azienda Sanitaria Regionale Molise - Ospedale F. Veneziale - Zona di Isernia
City
Isernia
State/Province
IS
ZIP/Postal Code
86170
Country
Italy
Facility Name
Ospedale Vito Fazzi
City
Lecce
State/Province
LE
ZIP/Postal Code
73100
Country
Italy
Facility Name
A.S.L. LT - Ospedale Santa Maria Goretti
City
Latina
State/Province
LT
ZIP/Postal Code
04100
Country
Italy
Facility Name
Ospedale Unico Versilia
City
Lido di Camaiore
State/Province
LU
ZIP/Postal Code
55041
Country
Italy
Facility Name
Ospedale San Luca
City
Lucca
State/Province
LU
ZIP/Postal Code
55100
Country
Italy
Facility Name
ASST Monza - Ospedale San Gerardo
City
Monza
State/Province
MB
ZIP/Postal Code
20052
Country
Italy
Facility Name
Ospedale di Macerata
City
Macerata
State/Province
MC
ZIP/Postal Code
62100
Country
Italy
Facility Name
ASST Melegnano e della Martesana - Ospedale Serbelloni
City
Gorgonzola
State/Province
MI
ZIP/Postal Code
20064
Country
Italy
Facility Name
ASST Ovest Milanese - Ospedale Nuovo di Legnano
City
Legnano
State/Province
MI
ZIP/Postal Code
20025
Country
Italy
Facility Name
ASST Fatebenefratelli Sacco - Ospedale Fatebenefratelli e Oftalmico
City
Milano
State/Province
MI
ZIP/Postal Code
20121
Country
Italy
Facility Name
Istituto Europeo di Oncologia (IRCCS)
City
Milano
State/Province
MI
ZIP/Postal Code
20141
Country
Italy
Facility Name
Azienda Ospedaliera Carlo Poma
City
Mantova
State/Province
MN
ZIP/Postal Code
46100
Country
Italy
Facility Name
A.O.U. Policlinico Modena
City
Modena
State/Province
MO
ZIP/Postal Code
41124
Country
Italy
Facility Name
A.O.U. Policlinico 'Paolo Giaccone'
City
Palermo
State/Province
PA
ZIP/Postal Code
90129
Country
Italy
Facility Name
Ospedale 'Guglielmo da Saliceto'
City
Piacenza
State/Province
PC
ZIP/Postal Code
29121
Country
Italy
Facility Name
Istituto Oncologico Veneto - I.R.C.C.S.
City
Padova
State/Province
PD
ZIP/Postal Code
35128
Country
Italy
Facility Name
Ospedale Civile 'San Massimo'
City
Penne
State/Province
PE
ZIP/Postal Code
65017
Country
Italy
Facility Name
Ospedale Civile di Città di Castello - A.S.L. n. 1
City
Città di Castello
State/Province
PG
ZIP/Postal Code
06012
Country
Italy
Facility Name
Ospedale S. Maria della Misericordia
City
Perugia
State/Province
PG
ZIP/Postal Code
06132
Country
Italy
Facility Name
A.O.U. Pisana - Ospedale Santa Chiara
City
Pisa
State/Province
PI
ZIP/Postal Code
56126
Country
Italy
Facility Name
Ospedale Felice Lotti - Azienda USL 5 di Pisa
City
Pontedera
State/Province
PI
ZIP/Postal Code
56025
Country
Italy
Facility Name
Policlinico Umberto I
City
Roma
State/Province
PM
ZIP/Postal Code
00186
Country
Italy
Facility Name
Azienda Ospedaliera Universitaria di Parma
City
Parma
State/Province
PR
ZIP/Postal Code
43100
Country
Italy
Facility Name
Ospedale Santa Croce - A.O. Ospedali Riuniti Marche Nord
City
Fano
State/Province
PS
ZIP/Postal Code
61032
Country
Italy
Facility Name
Fondazione S. Maugeri IRCCS
City
Pavia
State/Province
PV
ZIP/Postal Code
27100
Country
Italy
Facility Name
Azienda Ospedaliera S. Carlo
City
Potenza
State/Province
PZ
ZIP/Postal Code
85100
Country
Italy
Facility Name
Ospedale per gli Infermi
City
Faenza
State/Province
RA
ZIP/Postal Code
48018
Country
Italy
Facility Name
Ospedale Umberto I
City
Lugo
State/Province
RA
ZIP/Postal Code
48022
Country
Italy
Facility Name
Azienda Ospedaliera Bianchi - Melacrino - Morelli
City
Reggio Calabria
State/Province
RC
ZIP/Postal Code
89125
Country
Italy
Facility Name
Ospedale San Sebastiano
City
Correggio
State/Province
RE
ZIP/Postal Code
42015
Country
Italy
Facility Name
Ospedale Civile di Guastalla
City
Guastalla
State/Province
RE
ZIP/Postal Code
42016
Country
Italy
Facility Name
IRCCS A.O. S.Maria Nuova
City
Reggio Emilia
State/Province
RE
ZIP/Postal Code
42123
Country
Italy
Facility Name
Istituto Regina Elena per lo studio e la cura dei tumori
City
Roma
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Facility Name
Ospedale S. Eugenio
City
Roma
State/Province
RM
ZIP/Postal Code
00144
Country
Italy
Facility Name
Azienda Ospedaliera San Camillo - Forlanini
City
Roma
State/Province
RM
ZIP/Postal Code
00149
Country
Italy
Facility Name
Ospedale Fatebenefratelli San Giovanni Calibita - Isola Tiberina
City
Roma
State/Province
RM
ZIP/Postal Code
00186
Country
Italy
Facility Name
A.O. S. Andrea - Università 'La Sapienza' - II Facoltà di Medicina e Chirurgia
City
Roma
State/Province
RM
ZIP/Postal Code
00189
Country
Italy
Facility Name
Azienda Ospedaliera n. 1 - Annunziata
City
Sassari
State/Province
SS
ZIP/Postal Code
07100
Country
Italy
Facility Name
Fondazione del Piemonte per l'Oncologia - IRCC di Candiolo
City
Candiolo
State/Province
TO
ZIP/Postal Code
10060
Country
Italy
Facility Name
Ospedale S. Anna - A.O.U. Città della Salute e della Scienza
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
Ospedale S. Anna - Città della salute
City
Torino
State/Province
TO
ZIP/Postal Code
10126
Country
Italy
Facility Name
ASST della Valle Olona - Ospedale di Saronno
City
Saronno
State/Province
VA
ZIP/Postal Code
21047
Country
Italy
Facility Name
Ospedale Sacro Cuore Don Calabria
City
Negrar
State/Province
VE
ZIP/Postal Code
37024
Country
Italy
Facility Name
Ospedale Belcolle - AUSL di Viterbo
City
Viterbo
State/Province
VT
ZIP/Postal Code
01100
Country
Italy
Facility Name
A.O.U. Federico II
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Azienda Ospedaliera 'A. Cardarelli' (AORN)
City
Napoli
ZIP/Postal Code
80131
Country
Italy
Facility Name
Istituto Nazionale dei Tumori - Fondazione G.Pascale
City
Napoli
ZIP/Postal Code
80131
Country
Italy

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

CONcurrent vs SEqueNTial Adjuvant Treatments in Early Breast Cancer

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