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Trial record 1 of 1 for:    BRAVO niraparib
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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)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01905592
Recruitment Status : Completed
First Posted : July 23, 2013
Results First Posted : August 27, 2020
Last Update Posted : November 5, 2021
Sponsor:
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
Information provided by (Responsible Party):
Tesaro, Inc.

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Neoplasms, Breast
Carcinoma of Breast
Human Epidermal Growth Factor 2 Negative Carcinoma of Breast
BRCA1 Gene Mutation
BRCA2 Gene Mutation
Ovarian Neoplasms
Interventions Drug: niraparib
Drug: Physician's choice
Enrollment 215
Recruitment Details Previously treated, HER2 negative, germline BRCA mutation positive breast cancer patients were enrolled. The study was designed to randomize 306 patients, however enrollment was ended prematurely due to futility. Results are presented based on the primary analysis (data assessed from enrollment to end of follow-up, up to a maximum of 4 years).
Pre-assignment Details Of the 215 patients enrolled, 9 patients enrolled based on a local Breast Cancer gene (BRCA) test results were later determined to be BRCA wild type by central testing. Therefore, only 206 of the 215 patients enrolled were included in the analysis, and were considered in centrally confirmed intent-to-treat (ITT) population.
Arm/Group Title Physician's Choice Niraparib
Hide Arm/Group Description Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops. Niraparib 300 milligram (mg) (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
Period Title: Overall Study
Started [1] 71 135
Completed [1] 0 0
Not Completed 71 135
Reason Not Completed
Disease Progression             51             104
Toxicity             1             16
Physician Decision             0             2
New anti-cancer             1             0
Protocol Violation             0             1
Sponsor's decision             1             0
Not treated             7             3
Ongoing in Study             0             7
Withdrawal by Subject             10             2
[1]
Based on centrally confirmed intent-to-treat population
Arm/Group Title Physician's Choice Niraparib Total
Hide Arm/Group Description Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops. Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops Total of all reporting groups
Overall Number of Baseline Participants 71 135 206
Hide Baseline Analysis Population Description
The centrally-confirmed intent-to-treat population is defined as all randomized patients with a central confirmation of germline BRCA mutation.
Age, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 135 participants 206 participants
18-64
67
  94.4%
127
  94.1%
194
  94.2%
65-74
3
   4.2%
5
   3.7%
8
   3.9%
>=75
1
   1.4%
3
   2.2%
4
   1.9%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 135 participants 206 participants
Female
68
  95.8%
135
 100.0%
203
  98.5%
Male
3
   4.2%
0
   0.0%
3
   1.5%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 71 participants 135 participants 206 participants
Hispanic or Latino
6
   8.5%
6
   4.4%
12
   5.8%
Not Hispanic or Latino
50
  70.4%
110
  81.5%
160
  77.7%
Unknown or Not Reported
15
  21.1%
19
  14.1%
34
  16.5%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Race Number Analyzed 71 participants 135 participants 206 participants
Ashkenazi Jewish descendant
6
   8.5%
5
   3.7%
11
   5.3%
White or Caucasian
59
  83.1%
108
  80.0%
167
  81.1%
Black
3
   4.2%
6
   4.4%
9
   4.4%
Asian
0
   0.0%
2
   1.5%
2
   1.0%
Other
0
   0.0%
4
   3.0%
4
   1.9%
Unknown
1
   1.4%
3
   2.2%
4
   1.9%
Missing
2
   2.8%
7
   5.2%
9
   4.4%
1.Primary Outcome
Title Progression Free Survival (PFS) - Central Review Assessment
Hide Description The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of patients with advanced/metastatic human epidermal growth factor receptor 2 (HER2)-negative gBRCAmut 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 1.1 as determined by central review assessment.
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
Hide Outcome Measure Data
Hide Analysis Population Description
The intent-to-treat population is defined as all randomized patients with a central confirmation of germline BRCA mutation.
Arm/Group Title Physician's Choice Niraparib
Hide Arm/Group Description:
Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
Overall Number of Participants Analyzed 71 135
Median (95% Confidence Interval)
Unit of Measure: months
3.1
(1.6 to 7.2)
4.1
(2.9 to 4.5)
2.Secondary Outcome
Title Overall Survival
Hide Description To compare overall survival of patients with advanced/metastatic HER2-negative gBRCAmut breast cancer who have a gBRCAmut when treated with niraparib as compared to those treated with physician's choice. Overall Survival (OS) is 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
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population.
Arm/Group Title Physician's Choice Niraparib
Hide Arm/Group Description:
Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
Overall Number of Participants Analyzed 71 135
Median (95% Confidence Interval)
Unit of Measure: months
15.8
(12.1 to 18.4)
14.5
(11.7 to 17.2)
3.Secondary Outcome
Title Determine Concordance Between gBRCAmut Tests for the Purpose of Developing a Commercial Companion Diagnostic Test
Hide Description To establish germline BRCA (gBRCA) mutation status of screened patients using a centrally provided, validated test as well as future tests, and determine concordance between tests for the purpose of developing a commercial companion diagnostic test. The concordance of the candidate companion diagnostic test with the centralized gBRCA mutation test with respect to identifying gBRCA mutated patients will be evaluated using a separate blood sample. The sensitivity and specificity of the companion diagnostic test to the centralized validated test with respect to gBRCA status will be determined along with the corresponding 95% confidence intervals.
Time Frame End of study
Outcome Measure Data Not Reported
4.Secondary Outcome
Title Safety and Tolerability
Hide Description To evaluate safety and tolerability as measured by all adverse events (AEs). Safety and tolerability will be described using frequency of AEs and AEs of Common Terminology Criteria for Adverse Events (CTCAE) grade >=3. Safety analyses will include all patients who have received at least one dose of study drug and will be evaluated descriptively.
Time Frame End of Study
Outcome Measure Data Not Reported
5.Secondary Outcome
Title Progression Free Survival (PFS) - Investigator Assessment
Hide 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.
Time Frame Assessed up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population.
Arm/Group Title Physician's Choice Niraparib
Hide Arm/Group Description:
Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
Overall Number of Participants Analyzed 71 135
Median (95% Confidence Interval)
Unit of Measure: months
3.1
(2.7 to 5.1)
5.0
(4.2 to 5.5)
6.Secondary Outcome
Title Time to Treatment Failure
Hide Description To evaluate time to treatment failure (discontinuation of treatment for any reason). Time to treatment failure is 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. If progressive disease occurred earlier than treatment discontinuation, the date of progressive disease was considered the date of treatment failure. At the time of analysis, patients who were continuing to receive treatment were censored on the date of last contact.
Time Frame Date of randomization to discontinuation of treatment for any reason, up to 4 years
Hide Outcome Measure Data
Hide Analysis Population Description
Intent-to-treat Population.
Arm/Group Title Physician's Choice Niraparib
Hide Arm/Group Description:
Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops.
Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
Overall Number of Participants Analyzed 71 135
Median (95% Confidence Interval)
Unit of Measure: months
2.6
(1.6 to 3.2)
4.3
(4.0 to 5.5)
7.Secondary Outcome
Title Response Rate and Duration of Response
Hide Description To compare response rate and duration of response. The best response (complete response [CR], partial response [PR], stable disease [SD] or disease progression [PD]) for each patient will be summarized by treatment arm. The overall response rate (ORR) (ORR = CR+PR) will be summarized by treatment arm along with the corresponding exact 2-sided 95% confidence interval. A chi-square test will be used to compare ORR between the treatment arms. Duration of response will be summarized for the subgroup of patients that obtained objective response (CR or PR) using the Kaplan-Meier method and be displayed graphically where appropriate. The median duration and 2-sided 95% confidence interval for the median will be provided for each treatment arm.
Time Frame End of Study
Outcome Measure Data Not Reported
8.Secondary Outcome
Title To Compare Time to Deterioration of Health-related Quality of Life: QLQ-C30 and EQ-5D-5L
Hide Description To compare time to deterioration of health-related quality of life (HRQoL): European Organization for Research and Treatment of Cancer Quality of Life Questionnaire (EORTC QLQ-C30) and EuroQol 5 Dimension 5 Level (EQ-5D-5L). Patient reported outcomes were collected via questionnaires (EORTC QLQ-C30 and EQ-5D-5L). These had to be completed within 4 weeks prior to randomization and subsequent questionnaires were filled in every 2 cycles (ie. 6 weeks) while on-treatment and every 3 months while in follow- up. Collection of HRQoL data was limited to the first 12 months after randomization. The primary HRQoL endpoint considered relevant for this study is time to HRQoL deterioration (TTQ). TTQ is defined as the time from randomization to death, progression or clinical relevant deterioration in pre-specified QLQ-C30 scales. Patients who had not experienced an event at the time of analysis were censored at the time of the last completed HRQoL assessment.
Time Frame 13 months
Outcome Measure Data Not Reported
9.Secondary Outcome
Title Subsequent Therapies and Potential Relationships With Outcomes
Hide Description To describe subsequent therapies and potential relationships with outcomes
Time Frame End of Study
Outcome Measure Data Not Reported
10.Secondary Outcome
Title Assess Genetic and Non-genetic Biomarkers
Hide Description To assess genetic and non-genetic biomarkers relating to treatment efficacy. Germline and tumor mutations may be explored 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.
Time Frame End of Study
Outcome Measure Data Not Reported
11.Secondary Outcome
Title Assess Outcomes by Germline Mutation BRCA1 vs BRCA2
Hide Description To assess outcomes by germline mutation BRCA1 vs BRCA2
Time Frame End of Study
Outcome Measure Data Not Reported
12.Secondary Outcome
Title Post-treatment Data
Hide Description Descriptive summary statistics will be used to summarize post- treatment data (.i.e subsequent anticancer therapies and any new malignancy)
Time Frame End of Study
Outcome Measure Data Not Reported
Time Frame Up to 4 years
Adverse Event Reporting Description Safety analyses included all patients who have received at least one dose of study drug.
 
Arm/Group Title Physician's Choice Niraparib
Hide Arm/Group Description Physician selection from 4 standard of care metastatic breast cancer chemotherapies (eribulin or vinorelbine or gemcitabine or capecitabine), until progression or unacceptable toxicity develops. Niraparib 300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops
All-Cause Mortality
Physician's Choice Niraparib
Affected / at Risk (%) Affected / at Risk (%)
Total   39/65 (60.00%)   79/134 (58.96%) 
Hide Serious Adverse Events
Physician's Choice Niraparib
Affected / at Risk (%) Affected / at Risk (%)
Total   4/65 (6.15%)   33/134 (24.63%) 
Blood and lymphatic system disorders     
Thrombocytopenia * 1  0/65 (0.00%)  10/134 (7.46%) 
Anaemia * 2  0/65 (0.00%)  9/134 (6.72%) 
Febrile neutropenia * 2  0/65 (0.00%)  1/134 (0.75%) 
Leukopenia * 2  0/65 (0.00%)  1/134 (0.75%) 
Neutropenia * 2  0/65 (0.00%)  1/134 (0.75%) 
Cardiac disorders     
Pericardial effusion * 2  0/65 (0.00%)  1/134 (0.75%) 
Tachycardia * 2  0/65 (0.00%)  1/134 (0.75%) 
Gastrointestinal disorders     
Nausea * 1  0/65 (0.00%)  5/134 (3.73%) 
Vomiting * 2  1/65 (1.54%)  3/134 (2.24%) 
Constipation * 2  0/65 (0.00%)  2/134 (1.49%) 
Abdominal pain * 2  0/65 (0.00%)  1/134 (0.75%) 
Diarrhoea * 2  0/65 (0.00%)  1/134 (0.75%) 
Proctalgia * 2  0/65 (0.00%)  1/134 (0.75%) 
General disorders     
Pain * 2  1/65 (1.54%)  1/134 (0.75%) 
Pyrexia * 2  1/65 (1.54%)  1/134 (0.75%) 
Asthenia * 2  0/65 (0.00%)  1/134 (0.75%) 
Fatique * 2  0/65 (0.00%)  1/134 (0.75%) 
Malaise * 2  0/65 (0.00%)  1/134 (0.75%) 
Infections and infestations     
Pneumonia * 2  0/65 (0.00%)  2/134 (1.49%) 
Sepsis * 2  0/65 (0.00%)  2/134 (1.49%) 
Cellulitis * 2  0/65 (0.00%)  1/134 (0.75%) 
Lower respiratory tract infection * 2  0/65 (0.00%)  1/134 (0.75%) 
Lung infection * 2  0/65 (0.00%)  1/134 (0.75%) 
Pyelonephritis * 2  0/65 (0.00%)  1/134 (0.75%) 
Upper respiratory tract infection * 2  0/65 (0.00%)  1/134 (0.75%) 
Urinary tract infection * 2  0/65 (0.00%)  1/134 (0.75%) 
Injury, poisoning and procedural complications     
Accidental overdose * 2  0/65 (0.00%)  1/134 (0.75%) 
Investigations     
Platelet count decreased * 2  0/65 (0.00%)  2/134 (1.49%) 
Electrocardiogram ST segment depression * 2  0/65 (0.00%)  1/134 (0.75%) 
Metabolism and nutrition disorders     
Hypercalcaemia * 2  0/65 (0.00%)  1/134 (0.75%) 
Musculoskeletal and connective tissue disorders     
Back pain * 2  0/65 (0.00%)  1/134 (0.75%) 
Joint range of motion decreased * 2  1/65 (1.54%)  0/134 (0.00%) 
Nervous system disorders     
Headache * 2  1/65 (1.54%)  3/134 (2.24%) 
Dizziness * 2  0/65 (0.00%)  1/134 (0.75%) 
Hypoaesthesia * 2  0/65 (0.00%)  1/134 (0.75%) 
Language disorder * 2  1/65 (1.54%)  0/134 (0.00%) 
Syncope * 2  0/65 (0.00%)  1/134 (0.75%) 
Renal and urinary disorders     
Acute kidney injury * 2  1/65 (1.54%)  0/134 (0.00%) 
Micturition disorder * 1  1/65 (1.54%)  0/134 (0.00%) 
Respiratory, thoracic and mediastinal disorders     
Epistaxis * 2  0/65 (0.00%)  1/134 (0.75%) 
Pleurisy * 2  0/65 (0.00%)  1/134 (0.75%) 
Pleuritic pain * 2  0/65 (0.00%)  1/134 (0.75%) 
Respiratory failure * 2  0/65 (0.00%)  1/134 (0.75%) 
Vascular disorders     
Deep vein thrombosis * 2  0/65 (0.00%)  1/134 (0.75%) 
Hypotension * 2  0/65 (0.00%)  1/134 (0.75%) 
1
Term from vocabulary, MedDRA (Unspecified)
2
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Physician's Choice Niraparib
Affected / at Risk (%) Affected / at Risk (%)
Total   63/65 (96.92%)   134/134 (100.00%) 
Blood and lymphatic system disorders     
Anaemia * 1  23/65 (35.38%)  90/134 (67.16%) 
Nausea * 2  24/65 (36.92%)  81/134 (60.45%) 
Thrombocytopenia * 2  4/65 (6.15%)  48/134 (35.82%) 
Neutropenia * 2  19/65 (29.23%)  26/134 (19.40%) 
Leukopenia * 1  9/65 (13.85%)  11/134 (8.21%) 
Cardiac disorders     
Tachycardia * 2  2/65 (3.08%)  11/134 (8.21%) 
Gastrointestinal disorders     
Vomiting * 2  11/65 (16.92%)  49/134 (36.57%) 
Constipation * 2  11/65 (16.92%)  48/134 (35.82%) 
Diarrhoea * 2  22/65 (33.85%)  19/134 (14.18%) 
Abdominal pain * 2  10/65 (15.38%)  15/134 (11.19%) 
Abdominal pain upper * 2  3/65 (4.62%)  17/134 (12.69%) 
Stomatitis * 2  5/65 (7.69%)  15/134 (11.19%) 
Dry mouth * 2  5/65 (7.69%)  6/134 (4.48%) 
Dyspepsia * 2  1/65 (1.54%)  9/134 (6.72%) 
General disorders     
Fatigue * 2  29/65 (44.62%)  66/134 (49.25%) 
Asthenia * 2  9/65 (13.85%)  23/134 (17.16%) 
Dizziness * 2  6/65 (9.23%)  27/134 (20.15%) 
Insomnia * 2  5/65 (7.69%)  24/134 (17.91%) 
Pyrexia * 2  4/65 (6.15%)  15/134 (11.19%) 
Oedema peripheral * 2  6/65 (9.23%)  9/134 (6.72%) 
Palmar-plantar erythrodysaesthesia syndrome * 2  12/65 (18.46%)  0/134 (0.00%) 
Infections and infestations     
Viral upper respiratory tract infection * 2  3/65 (4.62%)  11/134 (8.21%) 
Upper respiratory tract infection * 2  4/65 (6.15%)  9/134 (6.72%) 
Urinary tract infection * 2  4/65 (6.15%)  7/134 (5.22%) 
Influenza like illness * 2  2/65 (3.08%)  8/134 (5.97%) 
Investigations     
Weight decreased * 2  10/65 (15.38%)  53/134 (39.55%) 
Platelet count decreased * 2  3/65 (4.62%)  43/134 (32.09%) 
Neutrophil count decreased * 2  10/65 (15.38%)  26/134 (19.40%) 
White blood cell count decreased * 2  5/65 (7.69%)  31/134 (23.13%) 
Alanine aminotransferase increased * 2  7/65 (10.77%)  18/134 (13.43%) 
Gamma-glutamyltransferase increased * 2  7/65 (10.77%)  17/134 (12.69%) 
Blood alkaline phosphatase increased * 2  5/65 (7.69%)  15/134 (11.19%) 
Aspartate aminotransferase increased * 2  5/65 (7.69%)  13/134 (9.70%) 
Lymphocyte count decreased * 2  4/65 (6.15%)  9/134 (6.72%) 
Weight increased * 2  7/65 (10.77%)  4/134 (2.99%) 
Metabolism and nutrition disorders     
Decreased appetite * 2  7/65 (10.77%)  41/134 (30.60%) 
Musculoskeletal and connective tissue disorders     
Back pain * 2  7/65 (10.77%)  30/134 (22.39%) 
Pain in extremity * 2  4/65 (6.15%)  19/134 (14.18%) 
Arthralgia * 2  8/65 (12.31%)  9/134 (6.72%) 
Bone pain * 2  5/65 (7.69%)  9/134 (6.72%) 
Musculoskeletal pain * 2  4/65 (6.15%)  9/134 (6.72%) 
Neck pain * 1  3/65 (4.62%)  10/134 (7.46%) 
Musculoskeletal chest pain * 2  4/65 (6.15%)  7/134 (5.22%) 
Myalgia * 2  5/65 (7.69%)  6/134 (4.48%) 
Nervous system disorders     
Headache * 2  10/65 (15.38%)  45/134 (33.58%) 
Dysgeusia * 2  5/65 (7.69%)  10/134 (7.46%) 
Paraesthesia * 2  6/65 (9.23%)  4/134 (2.99%) 
Psychiatric disorders     
Anxiety * 2  8/65 (12.31%)  18/134 (13.43%) 
Respiratory, thoracic and mediastinal disorders     
Dyspnoea * 2  8/65 (12.31%)  25/134 (18.66%) 
Cough * 2  5/65 (7.69%)  15/134 (11.19%) 
Epistaxis * 2  2/65 (3.08%)  10/134 (7.46%) 
Skin and subcutaneous tissue disorders     
Alopecia * 2  7/65 (10.77%)  3/134 (2.24%) 
Vascular disorders     
Hypertension * 2  1/65 (1.54%)  17/134 (12.69%) 
1
Term from vocabulary, MedDRA (Unspecified)
2
Term from vocabulary, MedDRA 20.0
*
Indicates events were collected by non-systematic assessment
IDMC interim analysis concluded that concerns with the quantity and quality of data in the control arm precluded meaningful comparative analyses and generation of a clinically useful endpoint, therefore enrollment was ended prematurely.
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There IS an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Neither Institution nor Investigator will submit for publication or public disclosure any publication or disclosure based on the results of the Study until after the first to occur of (a) publication of the Multi-Center Clinical Trial results; (b) notification by Sponsor that the Multi-Center Clinical Trial submission is no longer planned; or (c) the eighteen (18) month anniversary of the completion or early termination of the Multi-Center Clinical Trial.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: GSK Response Center
Organization: GlaxoSmithKline
Phone: 866-435-7343
EMail: GSKClinicalSupportHD@gsk.com
Layout table for additonal information
Responsible Party: Tesaro, Inc.
ClinicalTrials.gov Identifier: NCT01905592    
Other Study ID Numbers: 213551
1307-BCG, BIG5-13 ( Other Identifier: EORTC, BIG )
PR-30-5010-C ( Other Identifier: Tesaro )
First Submitted: July 18, 2013
First Posted: July 23, 2013
Results First Submitted: January 29, 2020
Results First Posted: August 27, 2020
Last Update Posted: November 5, 2021