A Phase I, Open-Label, 2 Part Multicentre Study to Assess the Safety and Efficacy of Olaparib in Combination With Carboplatin in Patients With Advanced HER-2 Negative Breast Cancer

Stopped early · Phase 1

Conditions studied: Breast Cancer

In brief

This is an open-label study to assess the safety, tolerability and efficacy of olaparib in combination with carboplatin. There are two parts in this study: Part A, a dose escalation in patients with advanced Human Epidermal Growth Factor 2 (HER-2) negative breast cancer and Part B, a dose expansion in the neoadjuvant treatment of HER-2 negative breast cancer patients with germline Breast Cancer Susceptibility Gene (BRCA)1/2 mutations.

Key facts

Study ID

NCT02561832

Run by

AstraZeneca

People needed

15

Starts

2015-11-06

Expected to finish

2017-02-01

Last updated by the study team

2019-02-20

Who can join

Age: 18 and older, up to 130. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Male or female aged ≥18 years
• Normal organ and bone marrow function, measured within 28 days prior to administration of study treatment
• Eastern Cooperative Oncology Group performance status of 0-1
• Postmenopausal or evidence of non-childbearing status for women of childbearing potential.
• Additional for patients participating in Part A only
• Advanced or metastatic breast cancer that is HER-2 negative (HR positive or HR negative)
• Between 0 and 2 lines of prior cytotoxic chemotherapy. Additional for patients participating in Part B only
• Patients with operable breast adenocarcinoma and no evidence of metastatic disease are allowed.
• Patient must meet at least one of the following criteria: Clinical primary tumour size defined as T2 or above, clinical or patho-histological evidence of regional lymph nodes involvement (N+), grade 2-3 disease
• Availability of formalin fixed, paraffin embedded tumour sample from diagnostic biopsies (Not Applicable for patients at sites in Israel)
• Histological confirmation of HER-2 negative breast cancer
• Documented germline mutation in BRCA1 or BRCA2 that is predicted to be deleterious or suspected deleterious
• Eligible for neo-adjuvant chemotherapy, but have not yet received neoadjuvant chemotherapy for breast cancer (chemo-naive) Exclusion criteria
• Exposure to an investigational product within 30 days or 5 half-lives (whichever is the longer) prior to enrolment
• Prior use of Poly ADP Ribose Polymerase (PARP) inhibitors
• Patients with a known hypersensitivity to olaparib or carboplatin
• Concurrent treatment with an ovarian hormonal replacement therapy or with hormonal agents such as raloxifene, tamoxifen or other selective estrogen receptor modulator. Patient must have discontinued use of such agents 3 weeks prior to beginning study treatment. Luteinising hormone-Releasing hormone (LHRH) analogues are allowed for all patients in Part A.
• Concomitant use of known potent Cytochrome P450 3A4 (CYP3A4) inhibitors and inducers
• Persistent toxicities (Common Terminology Criteria for Adverse Event (CTCAE) grade ≥2 and neuropathy CTCAE > grade 1) caused by previous cancer therapy, excluding alopecia - Patient with myelodysplastic syndrome (MDS)/acute myeloid leukaemia (AML) or with features suggestive of MDS/AML
• Patient must have recovered from any effects of any major surgery
• Patient considered at poor medical risk due to a serious, uncontrolled medical disorder, non-malignant systemic disease or active, uncontrolled seizures or active uncontrolled infection
• Patient with known active Hepatitis B or C, or Human immunodeficiency virus (HIV)
• Other malignancy within the last 5 years (few exceptions apply). Additional for patients participating in Part A only
• Prior chemotherapy within 3 weeks of study entry
• Other anti-cancer therapy (eg, targeted biotherapy of hormonal agents) within 3 weeks of study entry

Where it is running

• Research Site — New York, New York, United States
• Research Site — Stony Brook, New York, United States
• Research Site — Barcelona, Spain
• Research Site — Madrid, Spain
• Research Site — Madrid, Spain
• Research Site — Valencia, Spain
• Research Site — Zaragoza, Spain

Full record on ClinicalTrials.gov

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