Breast cancer
Conditions
Interventions
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
Sponsors
National Cancer Center Hospital
Eligibility
Sex/Gender
Female
Inclusion criteria
Inclusion criteria: 1)Histological confirmation of invasive breast cancer 2)Unresectable clinical StageIIIB, IIIC or IV or eligible for systemic chemotherapy for recurrent breast cancer 3)Histological confirmation of breast cancer without overexpression of HER2 (0 or 1+ in immunohistocompatibility (IHC), or negative in in-situ hybridization (ISH) tests). 4)Histological confirmation of hormonal receptor-negative breast cancer (Allred score < 3 in the IHC test for estrogen receptor and progesterone receptor). 5)PS (ECOG) 0 to 1 6)A treatment history of anthracycline and taxane agents, irrespective of the type of combination or treatment order 7)Patients with the following values in their latest laboratory tests -Neutrophil count > 1,500/mm3 -Hemoglobin > 9.0/dL -Platelet count > 100,000/mm3 -Total bilirubin < 1.5 mg/dL -Serum AST/ALT < 100 IU/L -Serum creatinine < 1.2 mg/dL -ECG Normal or minimal changes not requiring treatment and QTc interval < 450 ms 8)Recovery to grade 0 or 1 from all toxicities related to chemotherapy and radiotherapy, except for stable grade 0 to 2 sensory neuropathy and alopecia
Exclusion criteria
Exclusion 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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Phase I: Safety and tolerability Phase II: Response rates | — |
Countries
Japan
Contacts
Public ContactTamie Sukigara
National Cancer Center Clinical Trial Support Office
Outcome results
None listed