A randomised, double-blind, parallel group, placebo-controlled multi-centre Phase III study to assess the efficacy and safety of olaparib versus placebo as adjuvant treatment in patients with germline BRCA1/2 mutations and high risk HER2 negative primary breast cancer who have completed definitive local treatment and neoadjuvant or adjuvant chemotherapy.
- Conditions
- Breastcancer10006232
- Registration Number
- NL-OMON47654
- Lead Sponsor
- Astra Zeneca
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- Not specified
- Target Recruitment
- 40
Histologically confirmed non-metastatic primary triple negative invasive
adenocarcinoma of the breast.
TNBC or
ER and/or PgR positive/HER 2 negative patients
Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or
suspected deleterious (known or predicted to be detrimental/lead to loss of
function).
Completed adequate breast and axilla surgery. Completed at least 6 cycles
neoadjuvant or adjuvant chemotherapy containing anthracyclines, taxanes or the
combination of both. Prior platinum as potentially curative treatment for prior
cancer (e.g. ovarian) or as adjuvant or neoadjuvant treatment for breast cancer
is allowed.
ECOG performance status 0-1.
Any previous treatment with a PARP inhibitor, including olaparib and/or known
hypersensitivity to any of the excipients of study treatment
Patients with second primary cancer, EXCEPTIONS: adequately treated
non-melanoma skin cancer, curatively treated in situ cancer of the cervix,
Ductal Carcinoma in situ (DCIS) of the breast, stage 1 grade 1 endometrial
carcinoma, or other solid tumours including lymphomas (without bone marrow
involvement) curatively treated with no evidence of disease for >= 5 years prior
to randomization. More than one course of chemotherapy for previous malignancies
Resting ECG with QTc > 470 msec detected on 2 or more time points within a
24 hour period or family history of long QT syndrome. If ECG demonstrates QTc
>470 msec, patient will be eligible only if repeat ECG demonstrates QTc <=470
msec
Whole blood transfusions in the last 120 days prior to entry to the study which
may interfere with gBRCA testing
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method <p>Invasive Disease Free Survival (IDFS)</p><br>
- Secondary Outcome Measures
Name Time Method <p>Overall Survival (OS)<br /><br>Distant Disease Free Survival (DDFS)<br /><br>New primary invasive breast cancer and/or epithelial ovarian cancer in patients<br /><br>at risk for these events<br /><br>FACIT-fatigue symptom scale and EORTC-QLQ-C30 HrQoL scale (questionnaires)<br /><br>IDFS, DDFS and OS based on patients with gBRCA mutations confirmed by the<br /><br>central test (only required if population differs from the ITT (intention to<br /><br>treat) population)<br /><br>To determine the exposure to olaparib (in plasma) in patients receiving<br /><br>olaparib as adjuvant therapy</p><br>