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

Primary Purpose

Breast Cancer

Status
Terminated
Phase
Phase 2
Locations
Spain
Study Type
Interventional
Intervention
Eribulin
Sponsored by
MedSIR
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring breast cancer, Unresectable, ER, PR, Her2, recurrent, metastatic

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)FemaleDoes not accept 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.

Sites / Locations

  • Hospital de Jaén
  • Hospital Quiron Dexeus
  • Institut Català d'Oncologia
  • Complejo Asistencial Universitario de León
  • Hospital Ramón y Cajal
  • Hospital Universitario La Paz,
  • Hospital Son Llatzer
  • Hospital Universitario Dr Peset
  • Hospital Miguel Servet

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Eribulin monotherapy

eribulin plus endocrine therapy

Arm Description

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

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.

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

The progression-free survival (PFS)
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
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
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
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
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
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
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.

Full Information

First Posted
January 4, 2019
Last Updated
August 26, 2021
Sponsor
MedSIR
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1. Study Identification

Unique Protocol Identification Number
NCT03795012
Brief Title
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
August 2021
Overall Recruitment Status
Terminated
Why Stopped
Slow recruitment rate
Study Start Date
April 30, 2019 (Actual)
Primary Completion Date
March 31, 2021 (Actual)
Study Completion Date
March 31, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
MedSIR

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
breast cancer, Unresectable, ER, PR, Her2, recurrent, metastatic

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
22 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Eribulin monotherapy
Arm Type
Active Comparator
Arm Description
Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle
Arm Title
eribulin plus endocrine therapy
Arm Type
Active Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
Eribulin
Other Intervention Name(s)
Halaven
Intervention Description
Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.
Primary Outcome Measure Information:
Title
The overall response rate (ORR)
Description
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.
Time Frame
Baseline up to 27 months
Secondary Outcome Measure Information:
Title
The progression-free survival (PFS)
Description
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.
Time Frame
Baseline up to 27 months
Title
PFS-2, in the eribulin and the eribulin + ET arms
Description
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.
Time Frame
Baseline up to 27 months
Title
Overall response rate (ORR) in the eribulin arm
Description
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.
Time Frame
Baseline up to 27 months
Title
The duration of response (DOR) in the eribulin and the eribulin + ET arms
Description
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.
Time Frame
Baseline up to 27 months
Title
The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms
Description
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.
Time Frame
Baseline up to 27 months
Title
The overall survival (OS) in the eribulin and the eribulin + ET arms
Description
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).
Time Frame
Baseline up to 27 months
Title
Maximum Tumor shrinkage
Description
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.
Time Frame
Baseline up to 27 months

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Javier Cortés, PhD
Organizational Affiliation
MedSIR
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hospital de Jaén
City
Jaen
State/Province
Jaén
Country
Spain
Facility Name
Hospital Quiron Dexeus
City
Barcelona
State/Province
Please Select
Country
Spain
Facility Name
Institut Català d'Oncologia
City
Girona
Country
Spain
Facility Name
Complejo Asistencial Universitario de León
City
León
Country
Spain
Facility Name
Hospital Ramón y Cajal
City
Madrid
Country
Spain
Facility Name
Hospital Universitario La Paz,
City
Madrid
Country
Spain
Facility Name
Hospital Son Llatzer
City
Palma De Mallorca
Country
Spain
Facility Name
Hospital Universitario Dr Peset
City
Valencia
Country
Spain
Facility Name
Hospital Miguel Servet
City
Zaragoza
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

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

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