Olaparib Maintenance Monotherapy in Patients With BRCA Mutated Ovarian Cancer Following First Line Platinum Based Chemotherapy.

Inclusion Criteria:

• Female patients with newly diagnosed, histologically confirmed, high risk advanced (FIGO stage III - IV) BRCA mutated high grade serous or high grade endometrioidovarian cancer, primary peritoneal cancer and / or fallopian - tube cancer who havecompleted first line platinum based chemotherapy (intravenous or intraperitoneal).

• Stage III patients must have had one attempt at optimal debulking surgery (upfrontor interval debulking). Stage IV patients must have had either a biopsy and/orupfront or interval debulking surgery.

• Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious orsuspected deleterious (known or predicted to be detrimental/lead to loss offunction).

• Patients who have completed first line platinum (e.g. carboplatin or cisplatin),containing therapy (intravenous or intraperitoneal) prior to randomisation:

• Patients must have, in the opinion of the investigator, clinical complete responseor partial response and have no clinical evidence of disease progression on the posttreatment scan or rising CA-125 level, following completion of this chemotherapycourse. Patients with stable disease on the post-treatment scan at completion offirst line platinum-containing therapy are not eligible for the study.

• Patients must be randomized within 8 weeks of their last dose of chemotherapy

Exclusion Criteria:

• BRCA1 and/or BRCA2 mutations that are considered to be non detrimental (e.g. "Variants of uncertain clinical significance" or "Variant of unknown significance"or "Variant, favor polymorphism" or "benign polymorphism" etc).

• Patients with early stage disease (FIGO Stage I, IIA, IIB or IIC)

• Stable disease or progressive disease on the post-treatment scan or clinicalevidence of progression at the end of the patient's first line chemotherapytreatment.

• Patients where more than one debulking surgery has been performed beforerandomisation to the study. (Patients who, at the time of diagnosis, are deemed tobe unresectable and undergo only a biopsy or oophorectomy but then go on to receivechemotherapy and interval debulking surgery are eligible).

• Patients who have previously been diagnosed and treated for earlier stage ovarian,fallopian tube or primary peritoneal cancer.

• Patients who have previously received chemotherapy for any abdominal or pelvictumour, including treatment for prior diagnosis at an earlier stage for theirovarian, fallopian tube or primary peritoneal cancer. (Patients who have receivedprior adjuvant chemotherapy for localised breast cancer may be eligible, providedthat it was completed more than three years prior to registration, and that thepatient remains free of recurrent or metastatic disease).

• Patients with synchronous primary endometrial cancer unless both of the followingcriteria are met: 1) stage <2 2) less than 60 years old at the time of diagnosis ofendometrial cancer with stage IA or IB grade 1 or 2, or stage IA grade 3endometrioid adenocarcinoma OR ≥ 60 years old at the time of diagnosis ofendometrial cancer with Stage IA grade 1 or 2 endometrioid adenocarcinoma. Patientswith serous or clear cell adenocarcinoma or carcinosarcoma of the endometrium arenot eligible.