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

NCT03795012 | Terminated Phase 2

• 2 other identifiers: MedOPP1672017-004324-30
• Study Type: interventional
• Target: 22
• Locations: 1 country
• Sites: 9

Brief Summary

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

Conditions

Breast Cancer

Keywords

breast cancer; Unresectable; ER; PR; Her2; recurrent; metastatic

Outcome Measures

Primary Outcomes (1)

• The overall response rate (ORR)

  The overall response rate (ORR) in the eribulin + ET arms, defined as the proportion of patients with best overall response of confirmed complete response or partial response based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.

  Baseline up to 27 months

Secondary Outcomes (7)

• The progression-free survival (PFS)

  Baseline up to 27 months

• PFS-2, in the eribulin and the eribulin + ET arms

  Baseline up to 27 months

• Overall response rate (ORR) in the eribulin arm

  Baseline up to 27 months

• The duration of response (DOR) in the eribulin and the eribulin + ET arms

  Baseline up to 27 months

• The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms

  Baseline up to 27 months

Study Arms (2)

Eribulin monotherapy

ACTIVE COMPARATOR

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

Drug: Eribulin

eribulin plus endocrine therapy

ACTIVE COMPARATOR

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.

Drug: Eribulin

Interventions

Eribulin DRUG

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

Also known as: Halaven

Eribulin monotherapy; eribulin plus endocrine therapy

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• MedSIR: lead

Study Sites (9)

Hospital de Jaén

Jaén, Jaén, Spain

Location

Hospital Quiron Dexeus

Barcelona, Please Select, Spain

Location

Institut Català d'Oncologia

Girona, Spain

Location

Complejo Asistencial Universitario de León

León, Spain

Location

Hospital Ramón y Cajal

Madrid, Spain

Location

Hospital Universitario La Paz,

Madrid, Spain

Location

Hospital Son Llatzer

Palma de Mallorca, Spain

Location

Hospital Universitario Dr Peset

Valencia, Spain

Location

Hospital Miguel Servet

Zaragoza, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms; Recurrence; Neoplasm Metastasis

Interventions

eribulin

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Neoplastic Processes

Study Officials

• Javier Cortés, PhD

  MedSIR

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 4, 2019
• First Posted: January 7, 2019
• Study Start: April 30, 2019
• Primary Completion: March 31, 2021
• Study Completion: March 31, 2021
• Last Updated: August 31, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

ES (9)