Status:
TERMINATED
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
Lead Sponsor:
MedSIR
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
Detailed Description
Pre- and post-menopausal women age ≥ 18 years with unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC) with no prior line of chemotherapy...
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
April 30 2019
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
March 31 2021
Estimated Enrollment :
22 Patients enrolled
Trial Details
Trial ID
NCT03795012
Start Date
April 30 2019
End Date
March 31 2021
Last Update
August 31 2021
Active Locations (9)
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1
Hospital de Jaén
Jaén, Jaén, Spain
2
Hospital Quiron Dexeus
Barcelona, Please Select, Spain
3
Institut Català d'Oncologia
Girona, Spain
4
Complejo Asistencial Universitario de León
León, Spain