OlympiAD - Olaparib monotherapy V Physicians choice chemotherapy

• Research type

  Research Study

• Full title

  A Phase III, Open Label, Randomised, Controlled, Multi-centre Study to assess the efficacy and Safety of Olaparib Monotherapy versus Physicians Choice Chemotherapy in the Treatment of Metastatic Breast Cancer Patients with germline BRCA1/2 Mutations

• IRAS ID

  148426

• Contact name

  Anne Armstrong

• Contact email

  anne.armstrong@christie.nhs.uk

• Sponsor organisation

  AstraZenecaAB

• Eudract number

  2013-005137-20

• Clinicaltrials.gov Identifier

  NCT02000622

• Research summary

  Breast cancer is a life-threatening disease and is the second leading cause of cancer death among women. In the general population, BRCA mutation (Breast cancer susceptibility gene) carriers have an increased risk of breast cancer. There are no approved treatments for patients with germline BRCA1/2 mutations and these patients are treated according to their hormone receptor and HER2 status.
  Metastatic breast cancer is an incurable malignancy with a median survival of 20 to 24 months in unselected populations.
  Olaparib is an oral therapy being developed to treat patients with BRCA 1/2 mutations. Olaparib works by blocking particular chemicals called PARP enzymes. This is a new way to fight tumours with cells that cannot repair themselves properly. Tumours in patients with BRCA 1/2 are known to be sensitive to PARP blockers. This study will investigate whether giving oral Olaparib,to patients with BRCA mutated metastatic breast cancer, will have an effect on increasing the disease free time interval, when compared to Physicians choice of treatment of either capecitabine, vinorelbine or eribulin.
  Two thirds of the patients recruited will be randomly selected to receive Olaparib and the other third will receive Physicians choice of either capecitabine, vinorelbine or eribulin. After giving consent to take part, patients will attend regular hospital visits throughout the study. The number of study visits will depend on factors such as patients tolerance to treatment and time to disease progression. Disease progression will be assessed by CT scans at regular intervals throughout the study. Patients who discontinue study treatment and/or receive a subsequent therapy prior to disease progression will still continue to have CT scans as per study schedule until disease progression. Following confirmed disease progression, patients may be allowed to continue study treatment if the Study Physician and AZ Physician agree that the patient could continue to receive benefit.

• REC name

  North West - Liverpool Central Research Ethics Committee

• REC reference

  14/NW/0156

• Date of REC Opinion

  14 Apr 2014

• REC opinion

  Further Information Favourable Opinion