OlympiAD, 2017 trial summary    PDF trial summary

A randomised clinical trial investigating the effect of olaparib versus Physician s choice chemotherapy in women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation


NCT02000622    N Engl J Med 2017 Jun 4;:  
BRCA-mutated HER-2 negative

Studied treatment Olaparib (Olaparib tablet 300mg bd po)
olaparib tablets (300 mg twice daily)
Control treatment Physician's choice chemotherapy (Capecitabine 2500 mg/m2 d1-14 q 21, or Vinorelbine 30 mg/m2 d1,8 q 21, or Eribulin 1.4 mg/m2 d1,8 q 21)
standard therapy with one of the following three prespecified chemotherapy regimens: capecitabine administered orally at a dose of 2500 mg per square meter of body-surface area daily (divided into two doses) for 14 days, repeated every 21 days; eribulin mesylate administered intravenously at a dose of 1.4 mg on day 1 and day 8, repeated every 21 days; or vinorelbine administered intravenously at a dose of 30 mg on day 1 and day 8, repeated every 21 days

Patients women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation
Group sizes205 / 97
Inclusion criteria1) Germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious.; 2) Histologically or cytologically confirmed breast cancer with evidence of metastatic disease.; 3) Prior therapy with an anthracycline and a taxane in either an adjuvant or metastatic setting.; 4) 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.; 5) 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.; 6) ECOG performance status 0-1.; 7) Adequate bone marrow, kidney and liver function.;
Exclusion criteria1) Prior treatment with PARP inhibitor.; 2) Patients with HER2 positive disease.; 3) More than 2 prior lines of chemotherapy for metastatic breast cancer.; 4) Untreated and/or uncontrolled brain metastases.; 5) 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.; 6) Known HIV (Human Immunodeficiency Virus) infection.; 7) Pregnant or breast-feeding women.;

Blindness open label Inclusion period March 2014
Follow-up duration 14.5 months Centers
Lost to FU geographical localisation
Primary endpoint Progression Free Survival Design
PeriodeInclusionMarch 2014

EndpointX1N1X0N0TE95% CI OS - 205 - 97 0,90[0,63; 1,29] PFS - 205 - 97 0,58[0,43; 0,79] ORR - 205 - 97 no data treatment discontinuation due to toxic effects - 205 - 97 no data0,22,01,0

Robson M, Im SA, Senkus E, Xu B, Domchek SM, Masuda N, Delaloge S, Li W, Tung N, Armstrong A, Wu W, Goessl C, Runswick S, Conte P Olaparib for Metastatic Breast Cancer in Patients with a Germline BRCA Mutation. N Engl J Med 2017 Jun 4;:     [PMID: 28578601]   link to pdf   add to Mendeley  


Press Release

Press Release


ClinicalTrial.gov record NCT02000622

Registering number NCT02000622 (see trial on clinicaltrials.gov)
Code Name