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

NCT ID: NCT03795012

Last Updated: 2021-08-31

Basic Information

• Recruitment Status: TERMINATED
• Clinical Phase: PHASE2
• Total Enrollment: 22 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-04-30
• Study Completion Date: 2021-03-31

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 in the metastatic setting, and that have shown progression while on an aromatase inhibitor-containing regimen in the metastatic setting or within six months from last aromatase inhibitor dose in the adjuvant setting. Patients must have received at least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting. Subjects must have adequate bone marrow and creatinine clearance functions.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Eribulin monotherapy

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle

Group Type: ACTIVE_COMPARATOR

Eribulin

Intervention Type: DRUG

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.

eribulin plus endocrine therapy

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle, in combination with endocrine therapy (aromatase inhibitor). AI must be identical to the last AI administered to the patient, whether in the adjuvant or metastatic setting.

Group Type: ACTIVE_COMPARATOR

Eribulin

Intervention Type: DRUG

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.

Interventions

Eribulin

Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.

Intervention Type: DRUG

Other Intervention Names

Halaven

Eligibility 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

MedSIR

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Javier Cortés, PhD

Role: PRINCIPAL_INVESTIGATOR

MedSIR

Locations

Hospital de Jaén

Jaén, Jaén, Spain

Hospital Quiron Dexeus

Barcelona, Please Select, Spain

Institut Català d'Oncologia

Girona, , Spain

Complejo Asistencial Universitario de León

León, , Spain

Hospital Ramón y Cajal

Madrid, , Spain

Hospital Universitario La Paz,

Madrid, , Spain

Hospital Son Llatzer

Palma de Mallorca, , Spain

Hospital Universitario Dr Peset

Valencia, , Spain

Hospital Miguel Servet

Zaragoza, , Spain

Countries

Spain

Other Identifiers

2017-004324-30

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

MedOPP167

Identifier Type: -

Identifier Source: org_study_id