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

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



Studied treatment Olaparib (Olaparib tablet 300mg bd po)
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)



Patients women with human epidermal growth factor 2 (HER2)–negative metastatic breast cancer with a germline BRCA mutation
Group sizes-9 / -9
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 Inclusion period March 2014
Follow-up duration Centers
Lost to FU geographical localisation
Primary endpoint Progression Free Survival Design
PeriodeInclusionMarch 2014



EndpointX1N1X0N0TE95% CI0,22,01,0

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  

Links

Press Release

Press Release

Medscape

ClinicalTrial.gov record NCT02000622



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