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A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients (BRAVO)

Primary Purpose

Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast

Status
Terminated
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
niraparib
Physician's choice
Sponsored by
Tesaro, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Neoplasms, Breast focused on measuring Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation, BRCA2 Gene Mutation, PARP Inhibitor, BRCA

Eligibility Criteria

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

Inclusion Criteria:

  1. Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation.
  2. Histologically or cytologically confirmed HER2-negative metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent.
  3. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer; patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic therapy.

  4. Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting.

    a. Hormone receptor positive patients must also have hormone resistant disease; either relapsed while on adjuvant endocrine treatment, or within one year of completing adjuvant endocrine treatment, or progression on at least one line of endocrine treatment for advanced cancer.

  5. ECOG performance status 0-2
  6. Adequate bone marrow, kidney and liver function

Exclusion Criteria:

  1. Patients with platinum resistant cancer
  2. Symptomatic uncontrolled brain metastases
  3. Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval
  4. Known hypersensitivity to the components of niraparib
  5. Invasive cancer other than breast cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated)
  6. Pregnant or breast feeding patients
  7. Immunocompromised patients
  8. Known active Hepatitis B or C
  9. Prior treatment with a PARP inhibitor
  10. Known history of myelodysplastic syndrome (MDS).
  11. known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer treatment.

Sites / Locations

  • GSK Investigational Site
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  • GSK Investigational Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Physician's choice

niraparib

Arm Description

Physician may select from 4 active comparators

Patients will be randomized 2:1 to receive niraparib 300 mg (3x100 mg capsules) once daily for 21 continuous days

Outcomes

Primary Outcome Measures

Progression Free Survival (PFS) - Central Review Assessment
The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of participants with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCA mutation breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine). PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by central review assessment. Progressive Disease is defined as at least a 20 percent (%) increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of >= 5 millimeter (mm).

Secondary Outcome Measures

Overall Survival
Overall Survival (OS) was defined as the time from randomization to the date of death of any causes.
Number of Participants With Central BRCA Mutation Status
Blood samples were collected to evaluate central BRCA mutation status of participants. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Number of participants with central BRCA mutation status as BRCA1 positive only, BRCA2 positive only, Rearrangement only, BRCA1 and BRCA2 positive, BRCA1 positive and rearrangement, and BRCA2 positive and rearrangement were reported.
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE)
An adverse event (AE) is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence or effect in a participant, whether or not considered related to the protocol treatment, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing participant hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an medically important event or reaction as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
Progression Free Survival (PFS) - Investigator Assessment
PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per RECIST version 1.1 as determined by Investigator assessment. Progressive Disease is defined as at least a 20 % increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of >= 5 mm.
Time to Treatment Failure
Time to treatment failure was defined from the date of randomization to progression or discontinuation of treatment for any reason, including but not restricted to disease progression, treatment toxicity and death.
Overall Response Rate (ORR)
ORR was defined as the percentage of the participants who achieved a complete response (CR) or partial response (PR) to treatment evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR)=disappearance of all target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Partial Response (PR)= at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Percentage values are rounded off up to 1 decimal.
Duration of Response (DOR)
Duration of response was defined as the time from first documentation of response (confirmed CR or PR) until the time of first documentation of disease progression by RECIST v1.1 or death by any cause.
Number of Participants With Serious Adverse Events Related to New Malignancy
The number of participants with serious adverse events related to new malignancy were reported.
Number of Participants With Subsequent Anticancer Therapies
The number of participants with subsequent anticancer therapies were evaluated. Data has been reported as per following categories: any new anitumoral therapy, any chemotherapy, any radiotherapy, any surgery, any hormonal therapy, any targeted agents, and any other treatment. Participants may have received more than one subsequent therapies.

Full Information

First Posted
July 18, 2013
Last Updated
October 21, 2022
Sponsor
Tesaro, Inc.
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC, Breast International Group, Myriad Genetic Laboratories, Inc., US Oncology Research, Sarah Cannon, Facing Our Risk of Cancer Empowered
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1. Study Identification

Unique Protocol Identification Number
NCT01905592
Brief Title
A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Acronym
BRAVO
Official Title
A Phase III, Randomized, Open Label, Multicenter, Controlled Trial of Niraparib Versus Physician's Choice in Previously-treated, HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients
Study Type
Interventional

2. Study Status

Record Verification Date
October 2022
Overall Recruitment Status
Terminated
Why Stopped
The study was terminated due to futility.
Study Start Date
February 25, 2014 (Actual)
Primary Completion Date
May 23, 2018 (Actual)
Study Completion Date
October 26, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Tesaro, Inc.
Collaborators
European Organisation for Research and Treatment of Cancer - EORTC, Breast International Group, Myriad Genetic Laboratories, Inc., US Oncology Research, Sarah Cannon, Facing Our Risk of Cancer Empowered

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Data Monitoring Committee
Yes

5. Study Description

Brief Summary
The purpose of this study is to compare progression-free survival (PFS) in patients with advanced/metastatic breast cancer who have a BRCA mutation when treated with niraparib as compared to those treated with physician's choice
Detailed Description
This is a phase III, randomized, open label, multicenter, controlled trial of niraparib versus physician's choice in previously-treated, HER2 negative, germline BRCA mutation-positive breast cancer patients. Niraparib is an orally active PARP inhibitor. Niraparib (in a 2:1 ratio) will be administered once daily continuously during a 21-day cycle. Physician's choice will be administered on a 21-day cycle. Health-related quality of life will be measured. The safety and tolerability will be assessed by clinical review of adverse events (AEs), physical examinations, electrocardiograms (ECGs), and safety laboratory values.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Neoplasms, Breast, Carcinoma of Breast, Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation, BRCA2 Gene Mutation, Ovarian Neoplasms
Keywords
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast, BRCA1 Gene Mutation, BRCA2 Gene Mutation, PARP Inhibitor, BRCA

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Model Description
Randomization will be 2:1 (treatment:control) in at least 215 patients with germline BRCA mutations.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
216 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Physician's choice
Arm Type
Active Comparator
Arm Description
Physician may select from 4 active comparators
Arm Title
niraparib
Arm Type
Experimental
Arm Description
Patients will be randomized 2:1 to receive niraparib 300 mg (3x100 mg capsules) once daily for 21 continuous days
Intervention Type
Drug
Intervention Name(s)
niraparib
Other Intervention Name(s)
formerly MK-4827
Intervention Description
300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
Intervention Type
Drug
Intervention Name(s)
Physician's choice
Intervention Description
Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops
Primary Outcome Measure Information:
Title
Progression Free Survival (PFS) - Central Review Assessment
Description
The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of participants with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCA mutation breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards (eribulin, vinorelbine, gemcitabine or capecitabine). PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per Response evaluation criteria in solid tumors (RECIST) version (v)1.1 as determined by central review assessment. Progressive Disease is defined as at least a 20 percent (%) increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of >= 5 millimeter (mm).
Time Frame
From the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier, up to 4 years
Secondary Outcome Measure Information:
Title
Overall Survival
Description
Overall Survival (OS) was defined as the time from randomization to the date of death of any causes.
Time Frame
From treatment randomization to date of death of any cause, up to 4 years
Title
Number of Participants With Central BRCA Mutation Status
Description
Blood samples were collected to evaluate central BRCA mutation status of participants. Baseline was defined as the most recent non-missing measurement prior to or on the first administration of study drug. Number of participants with central BRCA mutation status as BRCA1 positive only, BRCA2 positive only, Rearrangement only, BRCA1 and BRCA2 positive, BRCA1 positive and rearrangement, and BRCA2 positive and rearrangement were reported.
Time Frame
At Baseline (Cycle 1 Day1) (Cycle duration was 21 days)
Title
Number of Participants With Serious Adverse Events (SAE) and Non-serious Adverse Events (Non-SAE)
Description
An adverse event (AE) is any untoward medical occurrence that occurs in a participant or clinical investigation participant administered a pharmaceutical product, and which does not necessarily have to have a causal relationship with this treatment. An SAE is defined as any untoward medical occurrence or effect in a participant, whether or not considered related to the protocol treatment, at any dose that results in death, is life-threatening, requires inpatient hospitalization or prolongation of existing participant hospitalization, results in persistent or significant disability or incapacity, is a congenital anomaly or birth defect, is an medically important event or reaction as per medical and scientific judgment. Adverse events which were not serious adverse events were considered as non serious adverse events.
Time Frame
Up to 7 years
Title
Progression Free Survival (PFS) - Investigator Assessment
Description
PFS is defined as the date of randomization to the date of disease progression or death due to any cause, whichever occurs earlier as per RECIST version 1.1 as determined by Investigator assessment. Progressive Disease is defined as at least a 20 % increase in the sum of diameters of measured lesions taking as references the smallest sum of diameters recorded on study (including Baseline) and an absolute increase of >= 5 mm.
Time Frame
Assessed up to 4 years
Title
Time to Treatment Failure
Description
Time to treatment failure was defined from the date of randomization to progression or discontinuation of treatment for any reason, including but not restricted to disease progression, treatment toxicity and death.
Time Frame
Date of randomization to discontinuation of treatment for any reason, up to 4 years
Title
Overall Response Rate (ORR)
Description
ORR was defined as the percentage of the participants who achieved a complete response (CR) or partial response (PR) to treatment evaluated using Response Evaluation Criteria in Solid Tumors (RECIST) v1.1. Complete Response (CR)=disappearance of all target and non-target lesions and normalization of tumor markers. Pathological lymph nodes must have short axis measures <10 mm. Partial Response (PR)= at least a 30% decrease in the sum of measures (longest diameter for tumor lesions and short axis measure for nodes) of target lesions, taking as reference the Baseline sum of diameters. Percentage values are rounded off up to 1 decimal.
Time Frame
Up to 4 years
Title
Duration of Response (DOR)
Description
Duration of response was defined as the time from first documentation of response (confirmed CR or PR) until the time of first documentation of disease progression by RECIST v1.1 or death by any cause.
Time Frame
Up to 4 years
Title
Number of Participants With Serious Adverse Events Related to New Malignancy
Description
The number of participants with serious adverse events related to new malignancy were reported.
Time Frame
Up to 7 years
Title
Number of Participants With Subsequent Anticancer Therapies
Description
The number of participants with subsequent anticancer therapies were evaluated. Data has been reported as per following categories: any new anitumoral therapy, any chemotherapy, any radiotherapy, any surgery, any hormonal therapy, any targeted agents, and any other treatment. Participants may have received more than one subsequent therapies.
Time Frame
Up to 7 years
Other Pre-specified Outcome Measures:
Title
Number of Participants With Minimally Clinically Important Difference (MCID) Status in European Organization for Research and Treatment of Cancer-Quality of Life Questionnaire-C30 (EORTC-QLQ-C30)
Description
The number of participants with MCID status in EORTC-QLQ-C30 was planned to be evaluated.The EORTC- QLQ-C30 includes 30-items with single and multi-item scales. These include five functional scales (physical functioning, role functioning cognitive functioning, emotional functioning and social functioning), three symptom scales (fatigue, pain and nausea/vomiting), a global health status (GHS)/ Quality-of-Life (QoL) scale, and six single items (constipation, diarrhea, insomnia, dyspnea, appetite loss and financial difficulties). Response options are 1 to 4. The average score can be transformed to 0 to 100, a high score for functional scales/ GHS/QoL represents better functioning ability or health-related quality-of-life (HRQoL), whereas a high score for symptom scales/ single items represents significant symptomatology.
Time Frame
Up to 7 years
Title
Number of Participants With Euroqol 5 Dimension 5 Level (EQ-5D-5L) Dimension Scores by Visit
Description
The number of participants with EQ-5D-5L scores by visit were planned to be evaluated. EQ-5D-5L is self-assessment questionnaire, consisting of 5 items covering 5 dimensions (mobility,self care, usual activities, pain/discomfort and anxiety/depression). Each dimension is measured by 5-point Likert scale(no problems, slight problems, moderate problems, severe problems and extreme problems). Responses for 5 dimensions together formed a 5-figure description of health state (e.g.11111 indicates no problems in all 5 dimensions). Each of these 5 figure health states were to be converted to a single index score. Range for EQ-5D-5L index score is 0 (worst health) to 100 (best health), higher the score better the health status.
Time Frame
Up to 7 years
Title
Number of Participants With Any Subsequent Therapies Post Discontinuation of Study Treatment and Association With Potential Survival Related Outcomes
Description
The number of participants with any subsequent therapies post-discontinuation of study treatment and association with potential survival related outcomes were planned to be evaluated.
Time Frame
Up to 7 years
Title
Number of Participants With Presence of Genetic and Non-genetic Biomarkers
Description
Biomarkers include germline and tumor mutations including somatic BRCA1 and 2 mutations, reversion mutations, loss of heterozygosity as well as genome landscape and transcriptional or functional measures of homologous recombination (HR) deficiency were planned to be evaluated.
Time Frame
Up to 7 years
Title
Number of Participants With Germline BRCA1 and BRCA2 Mutation Status in Association With Survival Related Outcomes
Description
Participants with germline BRCA1 and BRCA2 mutation status in association with survival related outcomes were planned to be evaluated.
Time Frame
Up to 7 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: Germline BRCA1 or BRCA2 mutation; patients with unknown BRCA status who meet NCCN BRCA screening criteria will be screened for BRCA mutation. Histologically or cytologically confirmed HER2-negative metastatic or locally advanced disease that is not amenable to resection or radiation with curative intent. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer; patients with no prior cytotoxic regimens for advanced or metastatic disease will only be allowed if they relapsed during or within 12 months of (neo-) adjuvant cytotoxic therapy. Prior therapy should have included a taxane and/or anthracycline (unless contraindication to those) in the neoadjuvant, adjuvant, or advanced/metastatic setting. a. Hormone receptor positive patients must also have hormone resistant disease; either relapsed while on adjuvant endocrine treatment, or within one year of completing adjuvant endocrine treatment, or progression on at least one line of endocrine treatment for advanced cancer. ECOG performance status 0-2 Adequate bone marrow, kidney and liver function Exclusion Criteria: Patients with platinum resistant cancer Symptomatic uncontrolled brain metastases Prior diagnosis of Stage IV ovarian cancer; Stage III ovarian cancer must have a 5-year disease-free interval; Stage II ovarian cancer must have a 2-year disease-free interval Known hypersensitivity to the components of niraparib Invasive cancer other than breast cancer within 2 years (except basal or squamous cell carcinoma of the skin that has been definitely treated) Pregnant or breast feeding patients Immunocompromised patients Known active Hepatitis B or C Prior treatment with a PARP inhibitor Known history of myelodysplastic syndrome (MDS). known and persistent (>4 weeks) >/= grade 3 toxicity or fatigue from prior cancer treatment.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
GSK Clinical Trials
Organizational Affiliation
GlaxoSmithKline
Official's Role
Study Director
Facility Information:
Facility Name
GSK Investigational Site
City
Tucson
State/Province
Arizona
ZIP/Postal Code
85710
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90033
Country
United States
Facility Name
GSK Investigational Site
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
GSK Investigational Site
City
Fort Myers
State/Province
Florida
ZIP/Postal Code
33901
Country
United States
Facility Name
GSK Investigational Site
City
Miami
State/Province
Florida
ZIP/Postal Code
33176
Country
United States
Facility Name
GSK Investigational Site
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02111
Country
United States
Facility Name
GSK Investigational Site
City
Omaha
State/Province
Nebraska
ZIP/Postal Code
68114
Country
United States
Facility Name
GSK Investigational Site
City
Henderson
State/Province
Nevada
ZIP/Postal Code
89074
Country
United States
Facility Name
GSK Investigational Site
City
Clifton Park
State/Province
New York
ZIP/Postal Code
12065
Country
United States
Facility Name
GSK Investigational Site
City
Lake Success
State/Province
New York
ZIP/Postal Code
11042
Country
United States
Facility Name
GSK Investigational Site
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44195
Country
United States
Facility Name
GSK Investigational Site
City
Eugene
State/Province
Oregon
ZIP/Postal Code
97401
Country
United States
Facility Name
GSK Investigational Site
City
Portland
State/Province
Oregon
ZIP/Postal Code
97225
Country
United States
Facility Name
GSK Investigational Site
City
Philadelphia
State/Province
Pennsylvania
ZIP/Postal Code
19111
Country
United States
Facility Name
GSK Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37203
Country
United States
Facility Name
GSK Investigational Site
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
GSK Investigational Site
City
Dallas
State/Province
Texas
ZIP/Postal Code
75237
Country
United States
Facility Name
GSK Investigational Site
City
Fort Worth
State/Province
Texas
ZIP/Postal Code
76104
Country
United States
Facility Name
GSK Investigational Site
City
San Antonio
State/Province
Texas
ZIP/Postal Code
78217
Country
United States
Facility Name
GSK Investigational Site
City
Webster
State/Province
Texas
ZIP/Postal Code
77598
Country
United States
Facility Name
GSK Investigational Site
City
Weslaco
State/Province
Texas
ZIP/Postal Code
78596
Country
United States
Facility Name
GSK Investigational Site
City
Low Moor
State/Province
Virginia
ZIP/Postal Code
24457
Country
United States
Facility Name
GSK Investigational Site
City
Everett
State/Province
Washington
ZIP/Postal Code
98201
Country
United States
Facility Name
GSK Investigational Site
City
Seattle
State/Province
Washington
ZIP/Postal Code
98111
Country
United States
Facility Name
GSK Investigational Site
City
Green Bay
State/Province
Wisconsin
ZIP/Postal Code
54311
Country
United States
Facility Name
GSK Investigational Site
City
Aalst
ZIP/Postal Code
9300
Country
Belgium
Facility Name
GSK Investigational Site
City
Brussels
ZIP/Postal Code
1200
Country
Belgium
Facility Name
GSK Investigational Site
City
Bruxelles
ZIP/Postal Code
1000
Country
Belgium
Facility Name
GSK Investigational Site
City
Edegem
ZIP/Postal Code
2650
Country
Belgium
Facility Name
GSK Investigational Site
City
Liège
ZIP/Postal Code
4000
Country
Belgium
Facility Name
GSK Investigational Site
City
Namur
ZIP/Postal Code
5000
Country
Belgium
Facility Name
GSK Investigational Site
City
Calgary
State/Province
Alberta
ZIP/Postal Code
T2N 4N2
Country
Canada
Facility Name
GSK Investigational Site
City
Kelowna
State/Province
British Columbia
ZIP/Postal Code
V1Y 5L3
Country
Canada
Facility Name
GSK Investigational Site
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2M9
Country
Canada
Facility Name
GSK Investigational Site
City
Montreal
State/Province
Quebec
ZIP/Postal Code
H2L 4M1
Country
Canada
Facility Name
GSK Investigational Site
City
Bordeaux
ZIP/Postal Code
33076
Country
France
Facility Name
GSK Investigational Site
City
Dijon Cedex
ZIP/Postal Code
21079
Country
France
Facility Name
GSK Investigational Site
City
Lille Cedex
ZIP/Postal Code
59020
Country
France
Facility Name
GSK Investigational Site
City
Lyon Cedex 08
ZIP/Postal Code
69373
Country
France
Facility Name
GSK Investigational Site
City
Montpellier
ZIP/Postal Code
34298
Country
France
Facility Name
GSK Investigational Site
City
Nantes cedex
ZIP/Postal Code
44202
Country
France
Facility Name
GSK Investigational Site
City
Paris Cedex 5
ZIP/Postal Code
75248
Country
France
Facility Name
GSK Investigational Site
City
Saint-Cloud
ZIP/Postal Code
92210
Country
France
Facility Name
GSK Investigational Site
City
Heraklion,Crete
ZIP/Postal Code
71110
Country
Greece
Facility Name
GSK Investigational Site
City
Maroussi
ZIP/Postal Code
15123
Country
Greece
Facility Name
GSK Investigational Site
City
Nea Kifissia
ZIP/Postal Code
14564
Country
Greece
Facility Name
GSK Investigational Site
City
Neo Faliro
ZIP/Postal Code
18547
Country
Greece
Facility Name
GSK Investigational Site
City
Thessaloniki
ZIP/Postal Code
57001
Country
Greece
Facility Name
GSK Investigational Site
City
Budapest
ZIP/Postal Code
1122
Country
Hungary
Facility Name
GSK Investigational Site
City
Debrecen
ZIP/Postal Code
4032
Country
Hungary
Facility Name
GSK Investigational Site
City
Miskolc
ZIP/Postal Code
3501
Country
Hungary
Facility Name
GSK Investigational Site
City
Nyiregyhaza
ZIP/Postal Code
4400
Country
Hungary
Facility Name
GSK Investigational Site
City
Pécs
ZIP/Postal Code
7624
Country
Hungary
Facility Name
GSK Investigational Site
City
Szeged
ZIP/Postal Code
6720
Country
Hungary
Facility Name
GSK Investigational Site
City
Reykjavik
ZIP/Postal Code
IS-101
Country
Iceland
Facility Name
GSK Investigational Site
City
Haifa
ZIP/Postal Code
3109601
Country
Israel
Facility Name
GSK Investigational Site
City
Holon
ZIP/Postal Code
58100
Country
Israel
Facility Name
GSK Investigational Site
City
Kfar-Saba
ZIP/Postal Code
44281
Country
Israel
Facility Name
GSK Investigational Site
City
Rehovot
ZIP/Postal Code
76100
Country
Israel
Facility Name
GSK Investigational Site
City
Tel Aviv
ZIP/Postal Code
6423906
Country
Israel
Facility Name
GSK Investigational Site
City
Tel Hashomer
ZIP/Postal Code
52621
Country
Israel
Facility Name
GSK Investigational Site
City
Meldola (FC)
State/Province
Emilia-Romagna
ZIP/Postal Code
47014
Country
Italy
Facility Name
GSK Investigational Site
City
Parma
State/Province
Emilia-Romagna
ZIP/Postal Code
43100
Country
Italy
Facility Name
GSK Investigational Site
City
Rimini
State/Province
Emilia-Romagna
ZIP/Postal Code
47900
Country
Italy
Facility Name
GSK Investigational Site
City
Viterbo
State/Province
Lazio
ZIP/Postal Code
01100
Country
Italy
Facility Name
GSK Investigational Site
City
Genova
State/Province
Liguria
ZIP/Postal Code
16132
Country
Italy
Facility Name
GSK Investigational Site
City
Cremona
State/Province
Lombardia
ZIP/Postal Code
26100
Country
Italy
Facility Name
GSK Investigational Site
City
Milano
State/Province
Lombardia
ZIP/Postal Code
20141
Country
Italy
Facility Name
GSK Investigational Site
City
Ancona
State/Province
Marche
ZIP/Postal Code
60020
Country
Italy
Facility Name
GSK Investigational Site
City
Lecce
State/Province
Puglia
ZIP/Postal Code
73100
Country
Italy
Facility Name
GSK Investigational Site
City
Prato
State/Province
Toscana
ZIP/Postal Code
59100
Country
Italy
Facility Name
GSK Investigational Site
City
Legnago (VR)
State/Province
Veneto
ZIP/Postal Code
37045
Country
Italy
Facility Name
GSK Investigational Site
City
Leiden, RC
ZIP/Postal Code
2333 ZA
Country
Netherlands
Facility Name
GSK Investigational Site
City
Limburg
ZIP/Postal Code
6229HX
Country
Netherlands
Facility Name
GSK Investigational Site
City
Zwolle
ZIP/Postal Code
8025 AB
Country
Netherlands
Facility Name
GSK Investigational Site
City
Lodz
ZIP/Postal Code
93-513
Country
Poland
Facility Name
GSK Investigational Site
City
Raciborz
ZIP/Postal Code
47-400
Country
Poland
Facility Name
GSK Investigational Site
City
Coimbra
ZIP/Postal Code
3000-075
Country
Portugal
Facility Name
GSK Investigational Site
City
Lisbon
ZIP/Postal Code
1400-038
Country
Portugal
Facility Name
GSK Investigational Site
City
Porto
ZIP/Postal Code
4200-072
Country
Portugal
Facility Name
GSK Investigational Site
City
Barcelona
ZIP/Postal Code
8035
Country
Spain
Facility Name
GSK Investigational Site
City
Burgos
ZIP/Postal Code
09005
Country
Spain
Facility Name
GSK Investigational Site
City
Cáceres
ZIP/Postal Code
10003
Country
Spain
Facility Name
GSK Investigational Site
City
L'Hospitalet de Llobregat
ZIP/Postal Code
8907
Country
Spain
Facility Name
GSK Investigational Site
City
Lerida
ZIP/Postal Code
25198
Country
Spain
Facility Name
GSK Investigational Site
City
Lugo
ZIP/Postal Code
27003
Country
Spain
Facility Name
GSK Investigational Site
City
Madrid
ZIP/Postal Code
28041
Country
Spain
Facility Name
GSK Investigational Site
City
Pamplona
ZIP/Postal Code
31008
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46009
Country
Spain
Facility Name
GSK Investigational Site
City
Valencia
ZIP/Postal Code
46015
Country
Spain
Facility Name
GSK Investigational Site
City
Vigo
ZIP/Postal Code
36312
Country
Spain
Facility Name
GSK Investigational Site
City
Southampton
State/Province
Hampshire
ZIP/Postal Code
SO16 6YD
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Northwood
State/Province
Middlesex
ZIP/Postal Code
HA6 2RN
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Headington, Oxford
State/Province
Oxfordshire
ZIP/Postal Code
OX3 7LJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Sutton
State/Province
Surrey
ZIP/Postal Code
SM2 5PT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Bebington, Wirral
ZIP/Postal Code
CH63 4JY
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Belfast
ZIP/Postal Code
BT9 7AB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Edinburgh
ZIP/Postal Code
EH4 2XU
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Glasgow
ZIP/Postal Code
G11 6NT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
NW1 2PG
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SE1 9RT
Country
United Kingdom
Facility Name
GSK Investigational Site
City
London
ZIP/Postal Code
SW3 6JJ
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Nottingham
ZIP/Postal Code
NG5 1PB
Country
United Kingdom
Facility Name
GSK Investigational Site
City
Whitchurch, Cardiff
ZIP/Postal Code
CF14 2TL
Country
United Kingdom

12. IPD Sharing Statement

Plan to Share IPD
No
Links:
URL
http://www.facingourrisk.org
Description
Facing our risk of cancer empowered website

Learn more about this trial

A Phase III Trial of Niraparib Versus Physician's Choice in HER2 Negative, Germline BRCA Mutation-positive Breast Cancer Patients

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