Phase 3
N=302
Assessment of the Efficacy and Safety of Olaparib Monotherapy Versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients With Germline BRCA1/2 Mutations.
Breast Cancer Metastatic · BRCA 1 Gene Mutation · BRCA 2 Gene Mutation
Bottom Line
View on ClinicalTrials.gov: NCT02000622 ↗Enrolled (actual)
302
Serious AEs
17.6%
Results posted
Dec 2017
Primary outcome: Primary: Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) — 7.0; 4.2 Months — p=0.0009
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 3
- Interventions
- Olaparib (Drug); Physician's choice chemotherapy (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- AstraZeneca
- Primary completion
- Dec 2016
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) |
7.0; 4.2 | 0.0009 sig |
| SECONDARY Time to Second Progression or Death (PFS2) |
13.2; 9.3 | 0.0033 sig |
| SECONDARY Overall Survival (OS) |
19.3; 19.6 | 0.5665 |
| SECONDARY Objective Response Rate (ORR) Using Blinded Independent Central Review (BICR) Data Assessed by Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) |
100; 19 | — |
| SECONDARY Adjusted Mean Change in Global Health Status/Quality of Life (QoL) Score From the European Organisation for Research and Treatment of Cancer - Quality of Life Questionnaire (EORTC QLQ-C30) |
3.9; -3.6 | 0.0035 sig |
| SECONDARY Progression-free Survival (PFS) Using Blinded Independent Central Review (BICR) According to Modified Response Evaluation Criteria In Solid Tumours (RECIST v1.1) in Patients Confirmed as Myriad CDx gBRCAm |
7.4; 4.2 | 0.0005 sig |
| SECONDARY Overall Survival (OS) at Final OS |
19.3; 17.1 | 0.5131 |
| SECONDARY Overall Survival (OS) at Extended OS |
19.3; 17.1 | 0.4167 |
Summary
This open label, randomised, controlled, multi-centre phase III study will assess the efficacy and safety of single agent olaparib vs standard of care based on physician's choice of capecitabine, vinorelbine or eribulin in metastatic breast cancer patients with gBRCA 1/2 mutations.
Eligibility Criteria
Inclusion Criteria
- Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.
- Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.
- Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.
- Prior platinum allowed as long as no breast cancer progression occurred on treatment or if given in adjuvant/neoadjuvant setting at least 12 months from last dose to study entry elapsed.
- ER/PR breast cancer positive patients must have received and progressed on at least one endocrine therapy (adjuvant or metastatic), or have disease that the treating physician believes to be inappropriate for endocrine therapy.
- ECOG performance status 0-1.
- Adequate bone marrow, kidney and liver function.
Exclusion Criteria
- Prior treatment with PARP inhibitor.
- Patients with HER2 positive disease.
- More than 2 prior lines of chemotherapy for metastatic breast cancer.
- Untreated and/or uncontrolled brain metastases.
- Prior malignancy unless curatively treated and disease-free for > 5 years prior to study entry. Prior adequately treated non-melanoma skin cancer, in situ cancer of the cervix, DCIS or stage I grade 1 endometrial cancer allowed.
- Known HIV (Human Immunodeficiency Virus) infection.
- Pregnant or breast-feeding women.
Data sourced from ClinicalTrials.gov (NCT02000622). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.