None listed
Conditions
Interventions
AstraZeneca’s Pharmaceutical Development, R&D Supply Chain will supply olaparib to the investigator as green film-coated tablets. Patients will be administered olaparib orally twice daily (bid) at 300
Sponsors
ASTRAZENECA - PERU,
Eligibility
Sex/Gender
All
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: 1.*Provision of informed consent prior to any study specific procedures 2.*Patients must be male or female ≥18 years of age 3.*Histologically or cytologically confirmed breast cancer with evidence of metastatic disease 4.Documented mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious (known or predicted to be detrimental/lead to loss of function) 5.*Patients must have received treatment with an anthracycline (e.g. doxorubicin, epirubicin) and a taxane (e.g. paclitaxel, docetaxel) in either an adjuvant or metastatic setting. Rest of inclusion criteria described in page 42 of protocol (english)
Exclusion criteria
Exclusion criteria: Involvement in the planning and/or conduct of the study (applies to AstraZeneca staff/BCA staff and/or staff at the study site). 2.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, favour polymorphism” or “benign polymorphism” etc.). 3.Cytotoxic chemotherapy or non-hormonal targeted therapy within 21 days of Cycle 1 Day 1 is not permitted. Endocrine therapy must have been discontinued 7 or more days before Cycle 1 Day 1. Palliative radiotherapy must have been completed 14 or more days before Cycle 1 Day 1. The patient can receive a stable dose of bisphosphonates or denosumab for bone metastases, before and during the study as long as these were started at least 2 weeks prior to study treatment. 4.*Patients with HER2-positive disease (3+ by IHC or ISH amplified > 2.0). Rest of exclusion criteria described in page 44 of protocol (english)
Countries
Bulgaria, China, Czech Republic, France, Hungary, Italy, Japan, Korea South, Mexico, Peru, Poland, Romania, Russian Federation, Spain, Switzerland, Taiwan, Turkey, United States
Contacts
Public ContactUrsula Isabel Rodriguez Frias
ASTRAZENECA PERU S.A.
Outcome results
None listed