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A Phase I/II, open-label, non-randomized, multi-center, dose escalation study of olaparib in combination with eribulin mesylate to assess the safety, tolerability, and efficacy in patients with recurrent or metastatic triple-negative-type breast cancer, who have received anthracycline and taxane agents

Basic Information

Recruitment status	Complete: follow-up complete
Health condition(s) or Problem(s) studied	Breast cancer
Date of first enrollment	2013/01/22
Target sample size	48
Countries of recruitment	Japan
Study type	Interventional
Intervention(s)	Eribulin mesylate administer day 1, day 8, tri-weekly interval. Olaparib administer continuously and/or intermittently according to in each cohort. The trial treatment will be continued until there is progressive disease.

Outcome(s)

Primary Outcome	Phase I: Safety and tolerability Phase II: Response rates
Secondary Outcome

Key inclusion & exclusion criteria

Age minimum	18years-old
Age maximum	Not applicable
Gender	Female
Include criteria
Exclude criteria	1)Pregnant or breast-feeding women, or women of child bearing potential who intend to become pregnant 2)Patients who received treatment (chemotherapy or study treatment) within 1 week from the last administration or underwent treatment procedures (surgery or exposure to radiation) within the 2 weeks preceding enrollment 3)Patients with respiratory failure requiring oxygen inhalation therapy 4)Patients requiring therapeutic dosages of warfarin or related agents 5)Patients with signs or symptoms of interstitial pneumonia or pulmonary fibrosis 6)Patients who are HBs antigen-positive, HCV antibody-positive and/or HIV antibody-positive (Patients who are HBV-DNA positive and/or HCV-RNA positive are cannot be allowed) 7)Patients with serious cardiovascular disease 8)Patients with diabetes mellitus associated with poor glycemic control or receiving insulin 9)Patients with metastases to brain 10)Patients with meningeal carcinomatosis 11)Patients with gastrointestinal obstruction or the symptoms of it 12)Patients with synchronous double cancer, not including lesions equivalent to carcinoma in situ or mucosal carcinoma considered healed with topical therapy 13)Patients who have no features suggestive of MDS/AML on peripheral blood smear 14)Patients receiving the following classes of CYP3A4 inhibitors and inducers -CYP3A4 inhibitors: Azole antifungals, Macrolide antibiotics, Protease inhibitors -CYP3A4 inducers: Phenytoin, Rifampicin, Carbamazepine, Barbiturate derivatives 15)Patients with history of treatment with or allergy to eribulin mesylate Patients with history of treatment with or allergy to PARP inhibitors