Olaparib therapy in high risk HER2 negative BRCA mutated breast cancer
Research type
Research Study
Full title
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.
IRAS ID
145475
Contact name
Andrew Tutt
Contact email
Sponsor organisation
AstraZeneca AB
Eudract number
2013-003839-30
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 relative risk of developing breast and ovarian cancer. There are no specific approved treatments for patients with germline BRCA1/2 mutations and these patients are treated according to their hormone receptor and HER2 status.
Olaparib is an investigational oral therapy, which works by blocking an enzyme called poly ADP ribose polymerase (PARP). PARP is a key enzyme in one of the DNA repair pathways in human cells. Inhibition of PARP is considered to result in a build-up of DNA damage in the cell, requiring repair via a pathway called Homologous Recombination repair (HR). Cancer cells with a mutation in BRCA 1/2 have a deficient HR pathway. Olaparib is being investigated in patients with BRCA 1/2 mutated ovarian and breast cancer.
This study will investigate whether giving olaparib to patients with Triple Negative Breast Cancer and a BRCA1/2 mutation after they have completed all standard of care treatment reduces the risk of the cancer coming back. Half of the patients recruited will receive olaparib and the other half placebo. After the patient has consented to take part, they will receive study treatment for a maximum of 12 months. Patients will attend for safety assessments at regular intervals during the treatment phase. Efficacy assessments will be performed on a 3 monthly basis during the first 2 years, followed by 6 monthly assessments for years 3, 4 and 5 and annually thereafter. All patients will have mammogram / breast MRI annually for 10 years beginning 6 months after randomisation. Patients will remain in the study for up to 10 years so that assessments of disease recurrence, new cancer and survival can be performed.
REC name
London - London Bridge Research Ethics Committee
REC reference
14/LO/0566
Date of REC Opinion
16 Jun 2014
REC opinion
Further Information Favourable Opinion