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

NCT01905592TerminatedPHASE3INTERVENTIONAL

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

Key Facts

Lead Sponsor

Tesaro, Inc.

Enrollment

216

Start Date

2014-02-25

Completion Date

2018-05-23

Study Type

INTERVENTIONAL

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

Interventions

niraparibPhysician's choice

Conditions

NeoplasmsBreastCarcinoma of BreastHuman Epidermal Growth Factor 2 Negative Carcinoma of BreastBRCA1 Gene MutationBRCA2 Gene MutationOvarian Neoplasms

Eligibility

Age Range

18 Years+

Sex

ALL

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.

Outcome Measures

Primary Outcomes

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).

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 Outcomes

Overall Survival

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

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.

Time frame: At Baseline (Cycle 1 Day1) (Cycle duration was 21 days)

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.

Time frame: Up to 7 years

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 frame: Assessed up to 4 years

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.

Time frame: Date of randomization to discontinuation of treatment for any reason, up to 4 years

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.

Time frame: Up to 4 years

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.

Time frame: Up to 4 years

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.

Time frame: Up to 7 years

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.

Time frame: Up to 7 years

Locations

GSK Investigational Site, Tucson, United States

GSK Investigational Site, Los Angeles, United States

GSK Investigational Site, Fort Myers, United States

GSK Investigational Site, Miami, United States

GSK Investigational Site, Boston, United States

GSK Investigational Site, Omaha, United States

GSK Investigational Site, Henderson, United States

GSK Investigational Site, Clifton Park, United States

GSK Investigational Site, Lake Success, United States

GSK Investigational Site, Cleveland, United States

GSK Investigational Site, Eugene, United States

GSK Investigational Site, Portland, United States

GSK Investigational Site, Philadelphia, United States

GSK Investigational Site, Nashville, United States

GSK Investigational Site, Dallas, United States

GSK Investigational Site, Fort Worth, United States

GSK Investigational Site, San Antonio, United States

GSK Investigational Site, Webster, United States

GSK Investigational Site, Weslaco, United States

GSK Investigational Site, Low Moor, United States

GSK Investigational Site, Everett, United States

GSK Investigational Site, Seattle, United States

GSK Investigational Site, Green Bay, United States

GSK Investigational Site, Aalst, Belgium

GSK Investigational Site, Brussels, Belgium

GSK Investigational Site, Edegem, Belgium

GSK Investigational Site, Liège, Belgium

GSK Investigational Site, Namur, Belgium

GSK Investigational Site, Calgary, Canada

GSK Investigational Site, Kelowna, Canada

GSK Investigational Site, Toronto, Canada

GSK Investigational Site, Montreal, Canada

GSK Investigational Site, Bordeaux, France

GSK Investigational Site, Dijon, France

GSK Investigational Site, Lille, France

GSK Investigational Site, Lyon, France

GSK Investigational Site, Montpellier, France

GSK Investigational Site, Nantes, France

GSK Investigational Site, Paris, France

GSK Investigational Site, Saint-Cloud, France

GSK Investigational Site, Heraklion,Crete, Greece

GSK Investigational Site, Marousi, Greece

GSK Investigational Site, Nea Kifissia, Greece

GSK Investigational Site, Neo Faliro, Greece

GSK Investigational Site, Thessaloniki, Greece

GSK Investigational Site, Budapest, Hungary

GSK Investigational Site, Debrecen, Hungary

GSK Investigational Site, Miskolc, Hungary

GSK Investigational Site, Nyíregyháza, Hungary

GSK Investigational Site, Pécs, Hungary

GSK Investigational Site, Szeged, Hungary

GSK Investigational Site, Reykjavik, Iceland

GSK Investigational Site, Haifa, Israel

GSK Investigational Site, Holon, Israel

GSK Investigational Site, Kfar Saba, Israel

GSK Investigational Site, Rehovot, Israel

GSK Investigational Site, Tel Aviv, Israel

GSK Investigational Site, Tel Litwinsky, Israel

GSK Investigational Site, Lecce, Italy

GSK Investigational Site, Meldola (FC), Italy

GSK Investigational Site, Parma, Italy

GSK Investigational Site, Rimini, Italy

GSK Investigational Site, Viterbo, Italy

GSK Investigational Site, Genoa, Italy

GSK Investigational Site, Cremona, Italy

GSK Investigational Site, Milan, Italy

GSK Investigational Site, Ancona, Italy

GSK Investigational Site, Prato, Italy

GSK Investigational Site, Legnago (VR), Italy

GSK Investigational Site, Leiden, RC, Netherlands

GSK Investigational Site, Limburg, Netherlands

GSK Investigational Site, Zwolle, Netherlands

GSK Investigational Site, Lodz, Poland

GSK Investigational Site, Racibórz, Poland

GSK Investigational Site, Coimbra, Portugal

GSK Investigational Site, Lisbon, Portugal

GSK Investigational Site, Porto, Portugal

GSK Investigational Site, Barcelona, Spain

GSK Investigational Site, Burgos, Spain

GSK Investigational Site, Cáceres, Spain

GSK Investigational Site, L'Hospitalet de Llobregat, Spain

GSK Investigational Site, Lleida, Spain

GSK Investigational Site, Lugo, Spain

GSK Investigational Site, Madrid, Spain

GSK Investigational Site, Pamplona, Spain

GSK Investigational Site, Valencia, Spain

GSK Investigational Site, Vigo, Spain

GSK Investigational Site, Southampton, United Kingdom

GSK Investigational Site, Northwood, United Kingdom

GSK Investigational Site, Headington, Oxford, United Kingdom

GSK Investigational Site, Sutton, United Kingdom

GSK Investigational Site, Bebington, Wirral, United Kingdom

GSK Investigational Site, Belfast, United Kingdom

GSK Investigational Site, Edinburgh, United Kingdom

GSK Investigational Site, Glasgow, United Kingdom

GSK Investigational Site, London, United Kingdom

GSK Investigational Site, Nottingham, United Kingdom

GSK Investigational Site, Whitchurch, Cardiff, United Kingdom

Linked Diseases

Ovarian Neoplasms

Ovarian Neoplasms — a type of gynecological cancer.