Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients

• Status: Terminated
• Trial end date: 2021-03-31
• Target enrollment: 0
• Participant gender: Female

Summary

Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: MedSIR

Criteria

Inclusion Criteria:

• ER-positive and/or PR-positive breast cancer.

• HER2-negative breast cancer.

• Unresectable locally advanced or metastatic breast cancer.

• Confirmed disease progression while in the last aromatase inhibition-containing regimen in the metastatic setting.

• At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting.

• Patients with no prior line of chemotherapy in the metastatic setting.

• At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting.

• ECOG score 0 or 1.

• Patients have adequate bone marrow and organ function.

• Patients must have measurable disease (RECIST v.1.1).

• Premenopausal with LHRH analogues for at least 28 days) and postmenopausal women.

• Patients must agree to not breastfeed during the study and for 3 months after the last dose of study treatment.

• Life expectancy greater or equal to 12 weeks.

• Patients agree to collection of blood samples (liquid biopsy) and optional collection of metastatic tumour sample (biopsy) at the time of inclusion and progression (if appropriate).

Exclusion Criteria:

• Have received radiation therapy or limited-field palliative radiotherapy within two weeks prior to Cycle 1, Day 1, or patients who have not recovered from radiotherapy-related toxicities.

• Have received prior chemotherapy for locally advanced or metastatic disease.

• Have peripheral neuropathy grade 2 or greater.

• QTc > 480 msec on basal assessments, history of congenital or personal history of long QT syndrome, Brugada syndrome, or Torsade de Pointes (TdP), or uncontrolled electrolyte disorders

• Child-bearing potential women not using highly effective methods of contraception.

• Known hypersensitivity to eribulin, endocrine therapy or its excipients.

• Other malignancies within the previous two years except adequately treated basal cell or squamous cell skin cancer or carcinoma in situ of cervix or breast.

• Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease.

• Have a serious concomitant systemic disorder incompatible with the study.

• Major surgical procedure or significant traumatic injury within 28 days prior to randomization.

• Have received any anti-cancer biology or investigational treatment within 30 days prior to randomization.