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

NCT ID: NCT01905592

Last Updated: 2022-11-15

Study Results

Results available

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Basic Information

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Recruitment Status

TERMINATED

Clinical Phase

PHASE3

Total Enrollment

216 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-02-25

Study Completion Date

2021-10-26

Brief Summary

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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

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Detailed Description

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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.

Conditions

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Neoplasms, Breast Carcinoma of Breast Human Epidermal Growth Factor 2 Negative Carcinoma of Breast BRCA1 Gene Mutation BRCA2 Gene Mutation Ovarian Neoplasms

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Randomization will be 2:1 (treatment:control) in at least 215 patients with germline BRCA mutations.
Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Physician's choice

Physician may select from 4 active comparators

Group Type ACTIVE_COMPARATOR

Physician's choice

Intervention Type DRUG

Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops

niraparib

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

Group Type EXPERIMENTAL

niraparib

Intervention Type DRUG

300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops

Interventions

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niraparib

300 mg (3x100 mg capsules) once daily until progression or unacceptable toxicity develops

Intervention Type DRUG

Physician's choice

Choice of 4 standard of care metastatic breast cancer chemotherapies, until progression or unacceptable toxicity develops

Intervention Type DRUG

Other Intervention Names

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formerly MK-4827

Eligibility Criteria

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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.
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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European Organisation for Research and Treatment of Cancer - EORTC

NETWORK

Sponsor Role collaborator

Breast International Group

OTHER

Sponsor Role collaborator

Myriad Genetic Laboratories, Inc.

INDUSTRY

Sponsor Role collaborator

US Oncology Research

INDUSTRY

Sponsor Role collaborator

Sarah Cannon

INDUSTRY

Sponsor Role collaborator

Facing Our Risk of Cancer Empowered

OTHER

Sponsor Role collaborator

Tesaro, Inc.

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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GSK Clinical Trials

Role: STUDY_DIRECTOR

GlaxoSmithKline

Locations

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GSK Investigational Site

Tucson, Arizona, United States

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Los Angeles, California, United States

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Los Angeles, California, United States

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Fort Myers, Florida, United States

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Miami, Florida, United States

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Boston, Massachusetts, United States

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Omaha, Nebraska, United States

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Henderson, Nevada, United States

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Clifton Park, New York, United States

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Lake Success, New York, United States

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Cleveland, Ohio, United States

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Eugene, Oregon, United States

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Portland, Oregon, United States

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Philadelphia, Pennsylvania, United States

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Nashville, Tennessee, United States

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Nashville, Tennessee, United States

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Dallas, Texas, United States

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Fort Worth, Texas, United States

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San Antonio, Texas, United States

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Webster, Texas, United States

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Weslaco, Texas, United States

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Low Moor, Virginia, United States

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Everett, Washington, United States

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Seattle, Washington, United States

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Green Bay, Wisconsin, United States

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Aalst, , Belgium

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Brussels, , Belgium

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Brussels, , Belgium

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Edegem, , Belgium

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Liège, , Belgium

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Namur, , Belgium

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Calgary, Alberta, Canada

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Kelowna, British Columbia, Canada

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Toronto, Ontario, Canada

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Montreal, Quebec, Canada

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Bordeaux, , France

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Dijon, , France

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Lille, , France

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Lyon, , France

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Montpellier, , France

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Nantes, , France

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Paris, , France

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Saint-Cloud, , France

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Heraklion,Crete, , Greece

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Marousi, , Greece

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Nea Kifissia, , Greece

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Neo Faliro, , Greece

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Thessaloniki, , Greece

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Budapest, , Hungary

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Debrecen, , Hungary

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Miskolc, , Hungary

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Nyíregyháza, , Hungary

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Pécs, , Hungary

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Szeged, , Hungary

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Reykjavik, , Iceland

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Haifa, , Israel

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Holon, , Israel

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Kfar Saba, , Israel

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Rehovot, , Israel

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Tel Aviv, , Israel

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Tel Litwinsky, , Israel

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Lecce, Apulia, Italy

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Meldola (FC), Emilia-Romagna, Italy

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Parma, Emilia-Romagna, Italy

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Rimini, Emilia-Romagna, Italy

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Viterbo, Lazio, Italy

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Genoa, Liguria, Italy

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Cremona, Lombardy, Italy

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Milan, Lombardy, Italy

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Ancona, The Marches, Italy

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Prato, Tuscany, Italy

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Legnago (VR), Veneto, Italy

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Leiden, RC, , Netherlands

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Limburg, , Netherlands

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Zwolle, , Netherlands

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Lodz, , Poland

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Racibórz, , Poland

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Coimbra, , Portugal

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Lisbon, , Portugal

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Porto, , Portugal

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Barcelona, , Spain

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Burgos, , Spain

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Cáceres, , Spain

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L'Hospitalet de Llobregat, , Spain

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Lleida, , Spain

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Lugo, , Spain

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Madrid, , Spain

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Pamplona, , Spain

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Valencia, , Spain

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Valencia, , Spain

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Vigo, , Spain

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Southampton, Hampshire, United Kingdom

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Northwood, Middlesex, United Kingdom

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Headington, Oxford, Oxfordshire, United Kingdom

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Sutton, Surrey, United Kingdom

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Bebington, Wirral, , United Kingdom

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Belfast, , United Kingdom

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Edinburgh, , United Kingdom

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Glasgow, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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London, , United Kingdom

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Nottingham, , United Kingdom

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GSK Investigational Site

Whitchurch, Cardiff, , United Kingdom

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Countries

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United States Belgium Canada France Greece Hungary Iceland Israel Italy Netherlands Poland Portugal Spain United Kingdom

Provided Documents

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Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Related Links

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http://www.facingourrisk.org

Facing our risk of cancer empowered website

Other Identifiers

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1307-BCG, BIG5-13

Identifier Type: OTHER

Identifier Source: secondary_id

PR-30-5010-C

Identifier Type: OTHER

Identifier Source: secondary_id

213551

Identifier Type: -

Identifier Source: org_study_id

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