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

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ClinicalTrials.gov Identifier: NCT03795012
Recruitment Status : Recruiting
First Posted : January 7, 2019
Last Update Posted : January 28, 2020
Sponsor:
Information provided by (Responsible Party):
MedSIR

Study Description
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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
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 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
Estimated Primary Completion Date : May 2021
Estimated Study Completion Date : September 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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
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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
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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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
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03795012


Contacts
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Contact: Almudena García Martínez +34 610 688 562 almudena.garcia@medsir.org
Contact: Alicia García +34 932 214 135 alicia.garcia@medsir.org

Locations
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Spain
Hospital de Jaén Recruiting
Jaen, Jaén, Spain
Contact: Pedro Sanchez Rovira         
Hospital Quiron Dexeus Recruiting
Barcelona, Please Select, Spain
Contact: Alejandro Martinez         
Principal Investigator: Alejandro Martinez         
Institut Català d'Oncologia Recruiting
Girona, Spain
Contact: Sonia Del Barco         
Principal Investigator: Sonia Del Barco         
Complejo Asistencial Universitario de León Recruiting
León, Spain
Contact: Ana López         
Principal Investigator: Ana López         
Hospital Ramón y Cajal Recruiting
Madrid, Spain
Principal Investigator: Alfonso Cortés         
Hospital Universitario La Paz, Recruiting
Madrid, Spain
Contact: Beatriz Castelo         
Principal Investigator: Beatriz Castelo         
Hospital Son Llatzer Recruiting
Palma De Mallorca, Spain
Contact: Isabel Garau         
Principal Investigator: Isabel Garau         
Hospital Universitario Dr Peset Recruiting
Valencia, Spain
Contact: Miguel Corbellas         
Principal Investigator: Miguel Corbellas         
Hospital Miguel Servet Recruiting
Zaragoza, Spain
Contact: Antonio Antón         
Principal Investigator: Antonio Antón         
Sponsors and Collaborators
MedSIR
Investigators
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Principal Investigator: Javier Cortés, PhD MedSIR
More Information
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Responsible Party: MedSIR
ClinicalTrials.gov Identifier: NCT03795012    
Other Study ID Numbers: MedOPP167
First Posted: January 7, 2019    Key Record Dates
Last Update Posted: January 28, 2020
Last Verified: January 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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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:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases