BRCA1 and BRCA2 / Posted 4 years ago
PARTNER: Randomised, phase II/III, 3 stage trial to evaluate the safety and efficacy of the addition of olaparib to platinum-based neoadjuvant chemotherapy in breast cancer patients with TNBC and/or Gbrca
Surgery is often used for early breast cancers.
Sometimes you have chemotherapy before surgery. This is called neo adjuvant chemotherapy. It can shrink the cancer and make the surgery more successful.
In this trial, researchers are looking at whether adding a drug called olaparib (also called Lynparza) improves neo adjuvant chemotherapy.
Olaparib is a type of biological therapy called a PARP-1 inhibitor. PARP is a protein that helps cells to repair. Doctors think that olaparib can stop the cancer cells from repairing themselves.
In this trial, people have 1 of the following:
- chemotherapy with olaparib
The chemotherapy drugs used in this trial are:
These are commonly used to treat breast cancer but are not routinely used to treat early breast cancer. Doctors want to use them in this trial because research has shown that the combination of these drugs is a successful treatment.
The main aims of the trial are to:
- find out how well olaparib and chemotherapy works as a treatment
- learn about the side effects
Inclusion Criteria :
- Written informed consent.
- Aged between 16 and 70
- Histologically confirmed invasive breast cancer.
- Clinical stage T1-4 N0-2 (tumour or metastatic node diameter &gt; 10mm)
- Confirmed ER-negative and HER2-negative. or
- Germline BRCA mutation positive, irrespective of hormone status but HER2 negative.
- Performance Status 0-1
Exclusion Criteria :
T0 tumour in absence of axillary node greater than 10mm
- TNBC with a non-basal phenotype and over-expressing Androgen Receptor
- Not suitable for neoadjuvant chemotherapy
- Distant metastases apparent prior to randomisation
- Prior history of invasive breast cancer within the last 5 years
- Previous PARP inhibitor use or any previous chemotherapy or targeted agent.
- Any previous chemotherapy or agent used for the treatment of cancer within the last 5 years
- Study start date : 23/05/2016
- Study end date : 15/05/2020
- Wales-Based Study Contact : please speak to your clinician