A multicenter, randomized, phase II trial evaluating the efficacy of eribulin monotherapy and eribulin plus endocrine therapy in locally- recurrent or metastatic breast cancer patients after progression on endocrine therapy (REVERT) - REVERT

Medica Scientia Innovation Research (MEDSIR)0 sites60 target enrollmentNovember 16, 2018

Conditionsuminal Metastatic Breast Cancer MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864 MedDRA version: 20.1 Level: LLT Classification code 10070575 Term: Estrogen receptor positive breast cancer System Organ Class: 100000004864 Therapeutic area: Diseases [C] - Cancer [C04]

DrugsHALAVEN

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: uminal Metastatic Breast Cancer
Sponsor: Medica Scientia Innovation Research (MEDSIR)
Enrollment: 60
Status: Active, not recruiting
Last Updated: 7 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

November 16, 2018

End Date

TBD

Last Updated

7 years ago

Study Type

Interventional clinical trial of medicinal product

Investigators

Sponsor

Medica Scientia Innovation Research (MEDSIR)

Eligibility Criteria

Inclusion Criteria

•Patients are eligible for inclusion only if they meet ALL of the following criteria:
•1\. Patients have been informed about the nature of study, and have agreed to participate in the study, and signed the informed consent approved by the institution’s independent ethical committee/institutional review board.
•2\. Female patients over 18 years of age.
•3\. Patients with a histologically confirmed diagnosis of ER\-positive and/or PR\-positive breast cancer by local laboratory.
•4\. Patients with HER2\-negative breast cancer through in situ hybridization test (fluorescence in situ hybridization \[FISH], chromogenic in situ hybridization \[CISH], or silver enhanced in situ hybridization \[SISH]) or negative immunohistochemical status of 0 or 1\+. If IHC is 2\+, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing.
•5\. Unresectable locally advanced or metastatic breast cancer.
•6\. Confirmed disease progression while in the last aromatase inhibition\- containing regimen in the metastatic setting (Note: not necessarily in the treatment line immediately prior to study entry) or within 6 months from last AI dose in the adjuvant setting. Treatment with prior CDK4/6 or mTOR inhibitor therapy is allowed.
•7\. At least one taxane or anthracycline regimen in either the adjuvant or the neoadjuvant setting.
•8\. Patients with no prior line of chemotherapy in the metastatic setting.
•9\. At least 1 and up to 3 prior lines of endocrine therapy in the metastatic setting (except for patients progressing during the adjuvant setting or before 6 months after completing adjuvant endocrine therapy).

Exclusion Criteria

•Patients will be excluded from the study if they meet ANY of the following criteria:
•1\. 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 to baseline or grade £ 1 (except alopecia) and/or from whom \=25% of the bone marrow has been previously irradiated.
•2\. Have received prior chemotherapy for locally advanced or metastatic disease.
•3\. Have peripheral neuropathy grade 2 or greater.
•4\. 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
•5\. Child\-bearing potential women not using highly effective methods of contraception (contraception should continue during dosing and up to 90 days after study drugs discontinuation).
•6\. Known hypersensitivity to eribulin, endocrine therapy or its excipients.
•7\. 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.
•8\. Known uncontrolled metastases to the central nervous system (CNS) or any progressing CNS disease. (Note: Known brain metastases are considered active, if brain imaging during screening demonstrates progression of existing metastases and/or appearance of new lesions compared to brain imaging performed at least four weeks earlier and/or neurological symptoms attributed to brain metastases have not returned to baseline and/or steroids were used for brain metastases within 28 days of randomization)
•9\. Have a serious concomitant systemic disorder (e.g. active infection including HIV, or cardiac disease) incompatible with the study (at the discretion of investigator)