Overview

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.