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

• ClinicalTrials.gov Identifier: NCT03795012
• Recruitment Status: Terminated
• First Posted: January 7, 2019
• Last Update Posted: August 31, 2021
• Sponsor: MedSIR
• Information provided by (Responsible Party): MedSIR

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 (Clinical Trial)
• 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: April 30, 2019
• Actual Primary Completion Date: March 31, 2021
• Actual Study Completion Date: March 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 Name: 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 Name: Halaven

Outcome Measures

Primary Outcome Measures :

1. The overall response rate (ORR) [ Time Frame: 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 :

1. The progression-free survival (PFS) [ Time Frame: 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.
2. PFS-2, in the eribulin and the eribulin + ET arms [ Time Frame: 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.
3. Overall response rate (ORR) in the eribulin arm [ Time Frame: 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.
4. The duration of response (DOR) in the eribulin and the eribulin + ET arms [ Time Frame: 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.
5. The clinical benefit rate (CBR) in the eribulin and the eribulin + ET arms [ Time Frame: 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.
6. The overall survival (OS) in the eribulin and the eribulin + ET arms [ Time Frame: 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).
7. Maximum Tumor shrinkage [ Time Frame: 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

• Ages Eligible for Study: 18 Years and older (Adult, Older Adult)
• Sexes Eligible for Study: Female
• Accepts Healthy Volunteers: No

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.

Contacts and Locations

Locations

Spain

Hospital de Jaén

Jaen, 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

Sponsors and Collaborators

MedSIR

Investigators

• Principal Investigator: Javier Cortés, PhD; MedSIR

More Information

• Responsible Party: MedSIR
• ClinicalTrials.gov Identifier: NCT03795012
• Other Study ID Numbers: MedOPP167; 2017-004324-30 ( EudraCT Number )
• First Posted: January 7, 2019
• Last Update Posted: August 31, 2021
• Last Verified: August 2021

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

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

Keywords provided by MedSIR:

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

Additional relevant MeSH terms:

Breast Neoplasms; Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases