Phase 2
N=54
Study to Assess The Efficacy and Safety of a PARP Inhibitor For The Treatment of BRCA-positive Advanced Breast Cancer
Breast Neoplasms
Bottom Line
View on ClinicalTrials.gov: NCT00494234 ↗Enrolled (actual)
54
Serious AEs
25.9%
Results posted
Jan 2015
Primary outcome: Primary: Confirmed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria — 25.0; 42.3 Percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Olaparib (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- AstraZeneca
- Primary completion
- Feb 2009
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Confirmed Objective Response Rate (ORR) According to Response Evaluation Criteria in Solid Tumors (RECIST) Criteria |
25.0; 42.3 | — |
| SECONDARY Duration of Response (DoR) to Olaparib |
140.5; 144.0 | — |
| SECONDARY Clinical Benefit Rate (CBR) |
70.8; 84.6 | — |
| SECONDARY Best Percentage Change in Tumor Size |
-10.14; -29.43 | — |
| SECONDARY Progression-free Survival (PFS) |
122; 193.5 | — |
| SECONDARY Number of Participants With Improvement in Eastern Co-operative Oncology Group (ECOG) Performance Status Total Score From Baseline |
1; 6; 0; 2 | — |
| SECONDARY Number of Participants With Treatment-emergent Adverse Events (TEAEs) and Treatment-emergent Serious Adverse Events (TESAEs) |
27; 27; 5; 9 | — |
| SECONDARY Number of Participants With Clinically Significant Changes in Vital Signs From Baseline |
1; 0; 1; 0 | — |
| SECONDARY Number of Participants With at Least 2-Grade Change From Baseline to Worst Toxicity Grade in Clinical Laboratory Parameters |
2; 3; 5; 11; 3; 6 | — |
Summary
The purpose of the study is to see if the drug KU-0059436 (olaparib) is effective and well tolerated in treating participants with measurable breast cancer gene (BRCA)1- or BRCA2-positive advanced breast cancer and for whom no curative therapeutic option exists.
Eligibility Criteria
Inclusion Criteria
- Advanced breast cancer with positive BRCA1 or BRCA2 status
- Failed at least one prior chemotherapy
- In investigators opinion, no curative standard therapy exists
- Measurable disease
Exclusion Criteria
- Brain metastases
- Less than 28 days since last treatment used to treat the disease
- Considered a poor medical risk due to a serious uncontrolled disorder
Data sourced from ClinicalTrials.gov (NCT00494234). 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.