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Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer (InTTercePT)

Primary Purpose

Metastatic Breast Cancer With a Isolated Brain Progression

Status
Recruiting
Phase
Phase 2
Locations
France
Study Type
Interventional
Intervention
Tucatinib
Pertuzumab
Trastuzumab
Hormone therapy
Pertuzumab/ Trastuzumab
Sponsored by
UNICANCER
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metastatic Breast Cancer With a Isolated Brain Progression

Eligibility Criteria

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

Inclusion Criteria:

  1. Male or female, Age ≥18;
  2. Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1;
  3. Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology;
  4. Documented isolated brain progression (defined as new or progressive brain metastases with stable or responding systemic disease) under pertuzumab and trastuzumab treatment (with or without taxane) for metastatic disease (There is no limit to the number and size of brain metastasis);
  5. Complete local treatment of brain progression (Surgery and/or radiation therapy) should have been completed no more than 12 weeks before inclusion and there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator;
  6. Able to undergo MRI scanning of the brain;
  7. Normal renal function: creatinine <1.5 x upper limit of normal (ULN);
  8. Adequate liver function: total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN (≤5 ULN in the presence of liver metastases);
  9. Normal hematological function: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; and hemoglobin ≥9.0 g/dL;
  10. Adequate cardiac functions, including:

    • 12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention
    • QT/Corrected QT interval (QTc) ≤470 msec for woman and ≤450 msec for men (mean of replicate values, correction per institutional standard) on the ECG at the screening visit and a normal kalemia
    • Left ventricular ejection fraction (LVEF) ≥50%
    • No history of Torsades de Pointes or other symptomatic QTc abnormality
  11. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 5.0 Grade 1 or to baseline (except alopecia or others toxicities not considered a safety risk for the patient at investigator's discretion);
  12. Stable dose of steroids at the time of enrolment;
  13. Women of childbearing potential must have a negative pregnancy test (blood or urine test) within 14 days prior to inclusion;
  14. Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment/therapy (association of trastuzumab, pertuzumab +/- tucatinib). Hormonal contraceptives such as birth control pills, patches, implants, or injections are not allowed in patients who are hormone receptor positive;
  15. Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent;
  16. Patients affiliated to the social security system (or equivalent);
  17. Patient must be willing and able to comply with the protocol for the duration of the trial including scheduled visits, treatment plan, laboratory tests, and examinations including follow-up.

Exclusion Criteria:

  1. Radiologic extra-cranial progression under pertuzumab and trastuzumab treatment, at the time of enrolment. The systemic disease must be stable or responding at the time of enrolment;
  2. Proven leptomeningeal disease;
  3. Any progressive brain lesion between the brain local treatment completion and the enrolment;
  4. Poorly controlled seizures (more than 1/week);
  5. Clinically significant cardiopulmonary disease;
  6. Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. Use of sensitive CYP3A substrates should be avoided one week before enrollment and during study treatment
  7. Previous treatment with a tyrosine kinase inhibitor;
  8. Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease;
  9. Positive for human immunodeficiency virus (HIV);
  10. Known prior severe hypersensitivity to tucatinib or compounds chemically or/and biologically similar or any component in its formulation;
  11. History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless the patient has been in remission and off all other cancer therapy for at least 3 years;
  12. Pregnant women or women who are breast-feeding;
  13. Inability to swallow tablets or significant gastrointestinal disease which would preclude the adequate oral absorption of medications;
  14. Person deprived of their liberty or under protective custody or guardianship or unable to give informed consent;
  15. Participation in another therapeutic trial within the 30 days prior to tucatinib treatment initiation.

Sites / Locations

  • Institut de Cancérologie de l'Ouest - Site Paul PapinRecruiting
  • Institut Sainte CatherineRecruiting
  • Centre Hospitalier Universitaire de BesanconRecruiting
  • Institut BergoniéRecruiting
  • Centre Francois BaclesseRecruiting
  • Centre Hospitalier René DubosRecruiting
  • Centre Jean PerrinRecruiting
  • Centre Georges François LeclercRecruiting
  • Centre hospitallier de ChartresRecruiting
  • Clinique Victor Hugo
  • Centre Hospitalier Universitaire de LimogesRecruiting
  • Polyclinique de Limoges
  • Centre Leon BerardRecruiting
  • Hôpital privé Jean MermozRecruiting
  • Hôpital Européen de MarseilleRecruiting
  • Centre de Cancerologie du Grand Montpellier
  • CRLC Val d'AurelleRecruiting
  • Polyclinique de GentillyRecruiting
  • Hopital Privé du ConfluentRecruiting
  • Centre Antoine LacassagneRecruiting
  • Groupe Hospitalier les Diaconesses Croix Saint Simon
  • Institut Curie
  • Institut Universitaire de Cancérologie AP-HP. Sorbonne Université, Hôpital TenonRecruiting
  • Centre Hospitalier de PauRecruiting
  • CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et OncologiRecruiting
  • Centre Hospitalier Annecy GenevoisRecruiting
  • Institut Jean GodinotRecruiting
  • Centre Eugène Marquis
  • Centre Henri BecquerelRecruiting
  • CHU Saint-Etienne
  • Institut Claudius RegaudRecruiting
  • Centre Hospitalier Universitaire de ToursRecruiting
  • Institut de Cancérologie de LorraineRecruiting
  • Gustave RoussyRecruiting

Arms of the Study

Arm 1

Arm Type

Experimental

Arm Label

Tucatinib plus systemic treatment with or without hormone therapy

Arm Description

Addition of tucatinib to the systemic treatment (pertuzumab and trastuzumab) with or without hormone therapy.

Outcomes

Primary Outcome Measures

Progression-Free Survival
The progression-free survival is defined as the proportion of patients with an objective tumor progression by imaging, or death from any cause, whichever occurs first at 6 months from inclusion. Progression will be determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in case of lesions identified at baseline. For patients without any evidence of evidence at inclusion, the progression will be defined as an appearance of a new lesion (measurable or not measurable).

Secondary Outcome Measures

Overall Survival
Overall Survival is defined as the time interval between the date of inclusion in the study and the date of death (all causes). Patients not known to have died at the time of analysis will be censored at the last recorded date on which the patient was known to be alive
Brain Progression-Free Survival
Brain Progression-Free Survival is defined as the time interval between the date of inclusion in the study and the date of documented progression of the brain metastases. Tumor progression will be evaluated according to RECIST v1.1, as determined by investigator assessment, or as the appearance of a lesion for patients in complete response (CR) at the brain level at the inclusion. Patients who have not progressed at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
Overall brain metastasis response
In patients who are not in CR at the brain level after local treatment: Overall brain metastasis response is defined as the best overall response of the brain metastases during the study. Brain metastases response will be evaluated according to RECIST v1.1, as determined by investigator assessment.
Incidence of treatment-emergent Adverse Events
Adverse Events will be graded according to National Cancer Institute-common terminology criteria for adverse events (NCI-CTCAE) v5.0

Full Information

First Posted
September 3, 2021
Last Updated
September 21, 2023
Sponsor
UNICANCER
Collaborators
Seagen Inc., ARCAGY/ GINECO GROUP
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1. Study Identification

Unique Protocol Identification Number
NCT05041842
Brief Title
Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer
Acronym
InTTercePT
Official Title
Treatment With Tucatinib in Addition to Pertuzumab and Trastuzumab in Patients With HER2-positive Metastatic Breast Cancer After Local Therapy of Isolated Brain Progression
Study Type
Interventional

2. Study Status

Record Verification Date
September 2023
Overall Recruitment Status
Recruiting
Study Start Date
December 17, 2021 (Actual)
Primary Completion Date
March 30, 2025 (Anticipated)
Study Completion Date
March 30, 2026 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
UNICANCER
Collaborators
Seagen Inc., ARCAGY/ GINECO GROUP

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with human epidermal growth factor 2 (HER2)-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group. These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease. The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.
Detailed Description
The overall survival of patients with metastatic breast cancer has steadily improved over the past decades, mainly due to advances in systemic treatment. Despite these advances, the development of brain metastases remains a serious and devastating complication that decreases quality of life and increases morbidity and mortality. More than a third of patients with HER2-positive breast cancer develop brain metastases during the course of the disease. For patients with isolated brain progression, local treatment is recommended whenever possible (stereotaxic radiosurgery and / or surgery) as well as the continuation of systemic treatment previously initiated even if the evidence of a benefit is weak. After local treatment these patients will have a higher risk of progression (cerebral and systemic). Therefore, the question of whether systemic treatment should be continued or changed remains an open question. In a pooled analysis of two phase 1b studies, patients who continued systemic treatment with tucatinib (in combination with T-DM1 or with trastuzumab and capecitabine) after treatment directed to the central nervous system demonstrated a better prognosis than that of patients who stopped tucatinib. The HER2CLIMB randomized study demonstrated that adding the investigational drug tucatinib to the standard treatment trastuzumab and capecitabine improved both progression-free survival and overall survival in people diagnosed with HER2-positive metastatic breast cancer, previously treated with trastuzumab, pertuzumab, and T-DM1. In patients with brain metastases, the 1-year progression-free survival was 25% in the tucatinib group and 0% in the placebo group. These results suggest that tucatinib may be a new standard treatment for HER2-positive metastatic disease. We anticipate that adding tucatinib to the trastuzumab / pertuzumab regimen will control brain metastases, prolong progression-free survival, and improve patient quality of life. The aim of the non-randomized phase II study, InTTercePT, is to evaluate the effectiveness of adding tucatinib to trastuzumab and pertuzumab in the event of cerebral progression, after the end of local treatment.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Metastatic Breast Cancer With a Isolated Brain Progression

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Model Description
Patients treated with pertuzumab and trastuzumab for metastatic breast cancer who will develop an isolated brain relapse treated with local treatment will receive tucatinib in addition to pertuzumab and trastuzumab. Tucatinib will be taken orally 300 mg twice a day, pertuzumab (420 mg) and trastuzumab (6 mg/kg) will be taken every 3 weeks.
Masking
None (Open Label)
Allocation
N/A
Enrollment
55 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Tucatinib plus systemic treatment with or without hormone therapy
Arm Type
Experimental
Arm Description
Addition of tucatinib to the systemic treatment (pertuzumab and trastuzumab) with or without hormone therapy.
Intervention Type
Drug
Intervention Name(s)
Tucatinib
Intervention Description
300 mg orally twice daily
Intervention Type
Drug
Intervention Name(s)
Pertuzumab
Other Intervention Name(s)
Perjeta®
Intervention Description
Initial loading: 840 mg Maintenance: 420 mg, 3-weekly
Intervention Type
Drug
Intervention Name(s)
Trastuzumab
Other Intervention Name(s)
Herceptin® or Biosimilar
Intervention Description
Intravenous formulation : Initial loading: 8 mg/kg Maintenance: 6 mg/kg, 3-weekly Subcutaneous formulation: 600 mg (fixed dose regardless of patient's body weight), 3-weekly
Intervention Type
Drug
Intervention Name(s)
Hormone therapy
Intervention Description
Anastrozole (1 mg/day) or letrozole (2.5 mg/day) or fulvestrant (2x250 mg at day 1 and day 15 then every 4 weeks after the first injection)
Intervention Type
Drug
Intervention Name(s)
Pertuzumab/ Trastuzumab
Other Intervention Name(s)
Phesgo®
Intervention Description
Initial loading: 1200 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight) Maintenance: 600 mg Pertuzumab / 600 mg Trastuzumab (regardless of body weight), 3-weekly
Primary Outcome Measure Information:
Title
Progression-Free Survival
Description
The progression-free survival is defined as the proportion of patients with an objective tumor progression by imaging, or death from any cause, whichever occurs first at 6 months from inclusion. Progression will be determined locally by the investigator through the use of Response Evaluation Criteria in Solid Tumors version 1.1 (RECIST v1.1) in case of lesions identified at baseline. For patients without any evidence of evidence at inclusion, the progression will be defined as an appearance of a new lesion (measurable or not measurable).
Time Frame
6 months
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival is defined as the time interval between the date of inclusion in the study and the date of death (all causes). Patients not known to have died at the time of analysis will be censored at the last recorded date on which the patient was known to be alive
Time Frame
Throughout study completion, up to 18 months
Title
Brain Progression-Free Survival
Description
Brain Progression-Free Survival is defined as the time interval between the date of inclusion in the study and the date of documented progression of the brain metastases. Tumor progression will be evaluated according to RECIST v1.1, as determined by investigator assessment, or as the appearance of a lesion for patients in complete response (CR) at the brain level at the inclusion. Patients who have not progressed at the time of analysis will be censored at the time of the latest date of assessment from their last evaluable RECIST assessment.
Time Frame
Throughout study completion, up to 18 months
Title
Overall brain metastasis response
Description
In patients who are not in CR at the brain level after local treatment: Overall brain metastasis response is defined as the best overall response of the brain metastases during the study. Brain metastases response will be evaluated according to RECIST v1.1, as determined by investigator assessment.
Time Frame
Throughout study completion, up to 18 months
Title
Incidence of treatment-emergent Adverse Events
Description
Adverse Events will be graded according to National Cancer Institute-common terminology criteria for adverse events (NCI-CTCAE) v5.0
Time Frame
Throughout study completion, up to 18 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Male or female, Age ≥18; Eastern Cooperative Oncology Group Performance Status (ECOG PS) 0-1; Histologically confirmed HER2 positive breast cancer, with HER2 positive defined by in situ hybridization (ISH), immunohistochemistry (IHC), or fluorescence in situ hybridization (FISH) methodology; Documented isolated brain progression (defined as new or progressive brain metastases with stable or responding systemic disease) under pertuzumab and trastuzumab treatment (with or without taxane) for metastatic disease (There is no limit to the number and size of brain metastasis); Complete local treatment of brain progression (Surgery and/or radiation therapy) should have been completed no more than 12 weeks before inclusion and there is no clinical indication for immediate re-treatment with local therapy in the opinion of the investigator; Able to undergo MRI scanning of the brain; Normal renal function: creatinine <1.5 x upper limit of normal (ULN); Adequate liver function: total bilirubin ≤1.5 ULN (unless documented Gilbert's syndrome); aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤2.5 ULN (≤5 ULN in the presence of liver metastases); Normal hematological function: Absolute neutrophil count (ANC) ≥1.5 x 10⁹/L; platelets count ≥100 x 10⁹/L; and hemoglobin ≥9.0 g/dL; Adequate cardiac functions, including: 12 Lead electrocardiograms (ECG) with normal tracing or non-clinically significant changes that do not require medical intervention QT/Corrected QT interval (QTcF) ≤470 msec for woman and ≤450 msec for men (mean of replicate values, correction per institutional standard) on the ECG at the screening visit and a normal kalemia Left ventricular ejection fraction (LVEF) ≥50% No history of Torsades de Pointes or other symptomatic QTc abnormality Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 5.0 Grade 1 or to baseline (except alopecia or others toxicities not considered a safety risk for the patient at investigator's discretion); Stable dose of steroids at the time of enrolment; Women of childbearing potential must have a negative pregnancy test (blood or urine test) within 14 days prior to inclusion; Woman of childbearing potential and male patients must agree to use adequate contraception for the duration of trial participation and up to 7 months after completing treatment/therapy (association of trastuzumab, pertuzumab +/- tucatinib). Hormonal contraceptives such as birth control pills, patches, implants, or injections are not allowed in patients who are hormone receptor positive; Patient must have signed a written informed consent form prior to any trial specific procedures. When the patient is physically unable to give their written consent, a trusted person of their choice, independent from the investigator or the sponsor, can confirm in writing the patient's consent; Patients affiliated to the social security system (or equivalent); Patient must be willing and able to comply with the protocol for the duration of the trial including scheduled visits, treatment plan, laboratory tests, and examinations including follow-up. Exclusion Criteria: Radiologic extra-cranial progression under pertuzumab and trastuzumab treatment, at the time of enrolment. The systemic disease must be stable or responding at the time of enrolment; Proven leptomeningeal disease; Any progressive brain lesion between the brain local treatment completion and the enrolment; Poorly controlled seizures (more than 1/week); Clinically significant cardiopulmonary disease; Used of a strong cytochrome P450 (CYP)2C8 inhibitor within 5 half-lives of the inhibitor, or use of a strong CYP3A4 or CYP2C8 inducer within 5 days prior to first dose of study treatment. Use of sensitive CYP3A substrates should be avoided one week before enrollment and during study treatment Previous treatment with a tyrosine kinase inhibitor; Carriers of Hepatitis B or Hepatitis C or have other known chronic liver disease; Positive for human immunodeficiency virus (HIV); Known prior severe hypersensitivity to tucatinib or compounds chemically or/and biologically similar or any component in its formulation; History of any other cancer (except non-melanoma skin cancer or carcinoma in-situ of the cervix) unless the patient has been in remission and off all other cancer therapy for at least 3 years; Pregnant women or women who are breast-feeding; Inability to swallow tablets or significant gastrointestinal disease which would preclude the adequate oral absorption of medications; Person deprived of their liberty or under protective custody or guardianship or unable to give informed consent; Participation in another therapeutic trial within the 30 days prior to tucatinib treatment initiation.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sandrine Marques
Phone
+33 (0) 1 73 79 73 03
Email
s-marques@unicancer.fr
First Name & Middle Initial & Last Name or Official Title & Degree
Jérôme Lemonnier, Ph
Phone
+33 (0) 1 71 93 67 02
Email
j-lemonnier@unicancer.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Thomas Bachelot, MD
Organizational Affiliation
Centre Leon Berard
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Anne-Claire Hardy-Bessard, MD
Organizational Affiliation
Centre Armoricain d'Oncologie
Official's Role
Principal Investigator
Facility Information:
Facility Name
Institut de Cancérologie de l'Ouest - Site Paul Papin
City
Angers
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Paule AUGEREAU
Facility Name
Institut Sainte Catherine
City
Avignon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Julien GRENIER
Facility Name
Centre Hospitalier Universitaire de Besancon
City
Besancon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Guillaume MEYNARD
Facility Name
Institut Bergonié
City
Bordeaux
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laura HAIK
Facility Name
Centre Francois Baclesse
City
Caen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Ioana HRAB
Facility Name
Centre Hospitalier René Dubos
City
Cergy - Pontoise
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Rolande NGUEFACK
Facility Name
Centre Jean Perrin
City
Clermont-ferrand
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Xavier DURANDO
Facility Name
Centre Georges François Leclerc
City
Dijon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Isabelle DESMOULINS
Facility Name
Centre hospitallier de Chartres
City
Le Coudray
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Chloe GENET
Facility Name
Clinique Victor Hugo
City
Le Mans
ZIP/Postal Code
72000
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hugues BOURGEOIS
Facility Name
Centre Hospitalier Universitaire de Limoges
City
Limoges
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Elise DELUCHE
Facility Name
Polyclinique de Limoges
City
Limoges
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Leon Berard
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Thomas Bachelot
Facility Name
Hôpital privé Jean Mermoz
City
Lyon
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Olfa DERBEL
Facility Name
Hôpital Européen de Marseille
City
Marseille
ZIP/Postal Code
13003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Véronique Brunel
Facility Name
Centre de Cancerologie du Grand Montpellier
City
Montpellier
Country
France
Individual Site Status
Withdrawn
Facility Name
CRLC Val d'Aurelle
City
Montpellier
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
William JACOT
Facility Name
Polyclinique de Gentilly
City
Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laurene GAVOILLE
Facility Name
Hopital Privé du Confluent
City
Nantes
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Dorothée CHOCTEAU-BOUJU
Facility Name
Centre Antoine Lacassagne
City
Nice
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Caroline BAILLEUX
Facility Name
Groupe Hospitalier les Diaconesses Croix Saint Simon
City
Paris
ZIP/Postal Code
75020
Country
France
Individual Site Status
Not yet recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Catherine Delbaldo
Facility Name
Institut Curie
City
Paris
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut Universitaire de Cancérologie AP-HP. Sorbonne Université, Hôpital Tenon
City
Paris
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Joseph GLIGOROV
Facility Name
Centre Hospitalier de Pau
City
PAU
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Kévin BOURCIER
Facility Name
CARIO - Centre Armoricain Radiothérapie Imagerie Médicale et Oncologi
City
Plerin
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Anne-Claire HARDY-BESSARD
Facility Name
Centre Hospitalier Annecy Genevois
City
Pringy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Laetitia STEFANI
Facility Name
Institut Jean Godinot
City
Reims
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Christelle JOUANNAUD
Facility Name
Centre Eugène Marquis
City
Rennes
Country
France
Individual Site Status
Withdrawn
Facility Name
Centre Henri Becquerel
City
Rouen
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Camille PETRAU
Facility Name
CHU Saint-Etienne
City
Saint-etienne
Country
France
Individual Site Status
Not yet recruiting
Facility Name
Institut Claudius Regaud
City
Toulouse
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Mony Ung
Facility Name
Centre Hospitalier Universitaire de Tours
City
Tours
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Hélène Vegas
Facility Name
Institut de Cancérologie de Lorraine
City
Vandœuvre-lès-Nancy
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Jean-Baptiste AISENFARB
Facility Name
Gustave Roussy
City
Villejuif
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Benjamin Verret

12. IPD Sharing Statement

Plan to Share IPD
No
IPD Sharing Plan Description
Individual Participant Data will not be shared at an individual level. Those data will be part of the study database including all enrolled patients.

Learn more about this trial

Treatment With Tucatinib in Patients With an Isolated Brain Progression of a Metastatic Breast Cancer

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