Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
Register:
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EUCTR |
Last refreshed on:
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20 August 2018 |
Main ID: |
EUCTR2013-000684-85-IS |
Date of registration:
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10/12/2013 |
Prospective Registration:
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Yes |
Primary sponsor: |
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Public title:
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A controlled study with Niraparib versus physician's choice in patients with previously-treated, HER2 negative, BRCA mutation-positive breast cancer
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Scientific title:
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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 |
Date of first enrolment:
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14/01/2014 |
Target sample size:
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306 |
Recruitment status: |
Not Recruiting |
URL:
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https://www.clinicaltrialsregister.eu/ctr-search/search?query=eudract_number:2013-000684-85 |
Study type:
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Interventional clinical trial of medicinal product |
Study design:
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Controlled: yes Randomised: yes Open: yes Single blind: no Double blind: no Parallel group: no Cross over: no Other: no If controlled, specify comparator, Other Medicinial Product: yes Placebo: no Other: no Number of treatment arms in the trial: 2
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Phase:
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Human pharmacology (Phase I): no
Therapeutic exploratory (Phase II): no
Therapeutic confirmatory - (Phase III): yes
Therapeutic use (Phase IV): no
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Countries of recruitment
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Belgium
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France
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Greece
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Hungary
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Iceland
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Italy
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Netherlands
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Poland
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Portugal
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Spain
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United Kingdom
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Contacts
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Name:
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Martin Huber
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Address:
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1000 Winter Street North #3300
02451
Waltham
United States |
Telephone:
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17812572536 |
Email:
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mhuber@tesarobio.com |
Affiliation:
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TESARO Inc. |
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Name:
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Martin Huber
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Address:
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1000 Winter Street North #3300
02451
Waltham
United States |
Telephone:
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17812572536 |
Email:
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mhuber@tesarobio.com |
Affiliation:
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TESARO Inc. |
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Key inclusion & exclusion criteria
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Inclusion criteria: 1. Histologically or cytologically confirmed HER2-negative metastatic or locally advanced breast cancer that is not amenable to resection or radiation with curative intent. 2. Female and male patients age at least 18 years. 3. Germline BRCA1 or BRCA2 mutation that is considered deleterious or suspected deleterious (include those mutations or translocations termed “deleterious” or “suspected deleterious” according to Myriad reporting) by analysis at a reference laboratory (Myriad Genetic Laboratories, Salt Lake City, UT, USA, or Myriad GmbH, Martinsried, Germany). 4. Measurable disease by RECIST v1.1 or non- measurable disease that is clinically evaluable (except sclerotic-only bone disease; bone-only disease that has a lytic component is allowed). 5. Patients must not have symptomatic uncontrolled brain metastases To be considered controlled, central nervous system (CNS) disease must have undergone treatment (whole brain radiation, radiosurgery or equivalent) at least 1 month previously and the patient has no new or progressive signs or symptoms related to the CNS disease, and are off steroid therapy two weeks. 6. Up to 2 prior cytotoxic regimens for advanced or metastatic breast cancer (not including adjuvant or neo-adjuvant therapy); 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. 7. Prior therapy should have included an anthracycline and a taxane (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 wihtin one year of completing adjuvant endocrine treatment, or progression on at least on line of endocrine treatment for advanced cancer. 8. Patients must not have received anticancer chemotherapy, radiotherapy, hormonal therapy, biological therapy, or any other investigational therapy within 3 weeks prior to the start of study treatment. Patients with persistent toxicity (except alopecia) > grade 1 from prior cancer therapy will also be excluded. Bisphosphonate and denosumab are allowed. 9. No prior treatment with a known or putative PARP inhibitor (except iniparib). No other anticancer agent (chemotherapy, hormonal therapy, or other agent) is to be permitted during the course of the study for any patient. 10. Patients must not be platinum resistant defined as: progression of cancer during or within 6 months of completion of prior platinum treatment. 11. ECOG performance status 0-2 (Appendix G). 12. Adequate organ function (assessed within 72 hours prior to the first dose): a. Absolute neutrophil count (ANC) = 1,500 cells/µL b. Platelets = 100,000 cells/µL c. Hemoglobin = 9 g/dL d. Serum creatinine = 1.5 × upper limit of normal (ULN) or = 50 mL/min using Cockcroft-Gault equation e. Total bilirubin = 1.5 × ULN OR direct bilirubin = ULN f. Aspartate transaminase (AST) and alanine transaminase (ALT) = 2.5 × ULN or < 5 × ULN with liver metastases 13. Patients able to swallow and retain oral tablets 14. Female patients must not be pregnant or breast feeding a. Female patient of childbearing potential must have a negative serum pregnancy test. 15. Patients of child bearing potential who are sexually active and their partners must agree to the use of a highly effective form of contraception throughout their participation during the st
Exclusion criteria: No exclusion criteria are defined per protocol
Age minimum:
Age maximum:
Gender:
Female: yes Male: yes
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Health Condition(s) or Problem(s) studied
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HER2 negative, BRCA germline mutated breast cancer MedDRA version: 14.1
Level: PT
Classification code 10006187
Term: Breast cancer
System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
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Therapeutic area: Diseases [C] - Cancer [C04]
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Intervention(s)
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Product Name: Niraparib Pharmaceutical Form: Capsule, hard INN or Proposed INN: Niraparib CAS Number: 1038915-60-4 Current Sponsor code: L-001946812-005R, L-001946812 and MK-4827 Other descriptive name: NIRAPARIB Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 100-
Pharmaceutical Form: INN or Proposed INN: VINORELBINE CAS Number: 71486-22-1 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 10-
Pharmaceutical Form: INN or Proposed INN: GEMCITABINE CAS Number: 95058-81-4 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 200-
Pharmaceutical Form: INN or Proposed INN: Capecitabine CAS Number: 154361-50-9 Other descriptive name: CAPECITABINE Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 150-
Pharmaceutical Form: INN or Proposed INN: ERIBULIN CAS Number: 253128-41-5 Concentration unit: mg/ml milligram(s)/millilitre Concentration type: equal Concentration number: 0.44-
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Primary Outcome(s)
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Primary end point(s): Progression free survival per central review
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Timepoint(s) of evaluation of this end point: Per Protocol
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Secondary Objective: To compare overall survival of patients with advanced/metastatic HER2-negative gBRCAmut breast cancer when treated with niraparib as compared to those treated with physician's choice single agent chemotherapy standards. - Establish germline BRCA mutation status of screened patients using a centrally provided, validated test. Additional tests will be performed to determine concordance between tests for the purpose of developing a commercial diagnostic test. - To evaluate safety and tolerability as measured in all AEs - To compare PFS using investigator assessment of progression - To evaluate time to treatment failure - To compare response rate and duration of response - To compare time to deterioration of health-related quality of life - To describe subsequent therapies and potential relationships with outcomes - To assess genectic and non-genetic biomarkers relating to treatment efficacy
For a detailed listing and for objectives 9 to 10 please refer to the Protocol.
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Main Objective: The primary objective of this study is to compare progression-free survival (PFS), as assessed by blinded central review, of patients with advanced/metastatic 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).
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Secondary Outcome(s)
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Timepoint(s) of evaluation of this end point: Per Protocol
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Secondary end point(s): 1. Overall survival (key secondary efficacy endpoint). 2. Determine concordance between gBRCAmut tests for the purpose of developing a commercial companion diagnostic test. 3. Safety and tolerability, as documented by AEs and laboratory values 4. PFS using investigator assessment of progression 5. Time to treatment failure 6. Response rate and duration of response 7. Health-related quality of life: QLQ-C30 and EQ5D-5L (see chapter 10). 8. Subsequent therapies and potential relationships with outcomes 9. To assess outcomes by germline mutation BRCA1 vs BRCA2
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Secondary ID(s)
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PR-30-5010-C
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117580
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Source(s) of Monetary Support
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TESARO Inc.
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Results
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Results available:
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Date Posted:
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Date Completed:
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URL:
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