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

Sponsor

MedSIR (Other)

Overall Status

Terminated

CT.gov ID

NCT03795012

Collaborator

(none)

Enrollment

Locations

Arms

Actual Duration (Months)

2.4

Patients Per Site

0.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease	Intervention/Treatment	Phase
Breast Cancer	Drug: Eribulin	Phase 2

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

22 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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)

Actual Study Start Date :

Apr 30, 2019

Actual Primary Completion Date :

Mar 31, 2021

Actual Study Completion Date :

Mar 31, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Eribulin monotherapy Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle	Drug: Eribulin Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone. Other Names: Halaven
Active Comparator: 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.	Drug: Eribulin Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone. Other Names: Halaven

Arm

Intervention/Treatment

Active Comparator: Eribulin monotherapy

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

Drug: Eribulin

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

Other Names:

Halaven

Active Comparator: 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.

Drug: Eribulin

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

Other Names:

Halaven

Outcome Measures

Primary Outcome Measures

The overall response rate (ORR) [Baseline up to 27 months]
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.

Secondary Outcome Measures

The progression-free survival (PFS) [Baseline up to 27 months]
The progression-free survival (PFS) for patients treated with endocrine therapy alone or in combination with eribulin is defined as the time from randomization until death by any cause or objective tumor progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
PFS-2, in the eribulin and the eribulin + ET arms [Baseline up to 27 months]
The PFS-2, in the eribulin and the eribulin + ET arms, defined as the time from the randomization to the second disease progression or death, i.e., PFS after the next line of treatment, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
Overall response rate (ORR) in the eribulin arm [Baseline up to 27 months]
The overall response rate (ORR) in the eribulin arm, 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.
The duration of response (DOR) in the eribulin and the eribulin + ET arms [Baseline up to 27 months]
The duration of response (DOR) in the eribulin and the eribulin + ET arms, defined as the time from the start of the treatment to disease progression based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
The clinical benefit rate (CBR) 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, defined as the proportion of patients with no disease progression after 6 months of therapy, based on local investigator's assessment according to Response Evaluation Criteria In Solid Tumours (RECIST) criteria v. 1.11.
The overall survival (OS) in the eribulin and the eribulin + ET arms [Baseline up to 27 months]
The overall survival (OS) in the eribulin and the eribulin + ET arms, defined as the length of time that patients remain alive from the start of treatment (OS will be collected at the end of the study).
Maximum Tumor shrinkage [Baseline up to 27 months]
Maximum Tumor shrinkage, defined as the percentage of tumor shrinkage from baseline (obtained from the sum of the largest diameters of the target lesions), based on local investigator's assessment according to RECIST criteria guidelines (version 1.1)1.

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

Female

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country
1	Hospital de Jaén	Jaen	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
5	Hospital Ramón y Cajal	Madrid		Spain
6	Hospital Universitario La Paz,	Madrid		Spain
7	Hospital Son Llatzer	Palma De Mallorca		Spain
8	Hospital Universitario Dr Peset	Valencia		Spain
9	Hospital Miguel Servet	Zaragoza		Spain