Breast CancerPhase 2NCT03795012
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
A Phase 2 study testing Eribulin in people with Breast Cancer, run by MedSIR at 9 sites in Spain.
Trial summary
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC). Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Eribulin
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 22 participants
- Where
- 9 sitesSpain
- Study dates
- 30 Apr 2019to 31 Mar 2021
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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).
Who cannot join
- 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.
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- 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.
Trial locations and contacts
9 sites in 1 country.
9 sites in 1 country
Spain9 sites
Hospital Quiron Dexeus
Barcelona, Please Select
Institut Català d'Oncologia
Girona
Hospital de Jaén
Jaén, Jaén
Complejo Asistencial Universitario de León
León
Hospital Ramón y Cajal
Madrid
Hospital Universitario La Paz,
Madrid
Hospital Son Llatzer
Palma de Mallorca
Hospital Universitario Dr Peset
Valencia
Hospital Miguel Servet
Zaragoza
About this study
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)
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
Read the 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.
- Conditions
- Breast Cancer
- Being tested
- Eribulin
- Keywords
- breast cancer, Unresectable, ER, PR, Her2, recurrent, metastatic
- Medical subject headings
- Breast Neoplasms, Recurrence, Neoplasm Metastasis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
EribulinDrug
Also called Halaven
Patients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone.
| Study group | Role | What they receive |
|---|---|---|
| Eribulin monotherapy | Active comparator | Patients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle Receives: Drug: Eribulin |
| eribulin plus endocrine therapy | Active comparator | 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. Receives: Drug: Eribulin |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Baseline up to 27 months
Secondary outcomes (7)
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.
Measured: Baseline up to 27 months
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.
Measured: Baseline up to 27 months
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.
Measured: Baseline up to 27 months
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.
Measured: Baseline up to 27 months
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.
Measured: Baseline up to 27 months
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).
Measured: Baseline up to 27 months
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.
Measured: Baseline up to 27 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Jan 2019
- Study start30 Apr 2019
- Primary completion31 Mar 2021
- Study completion31 Mar 2021
Why it stopped: Slow recruitment rate
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 22 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Javier Cortés, PhD, Principal investigator, MedSIR
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03795012
- Sponsor's protocol ID
- MedOPP167
- Other IDs
- 2017-004324-30, 2017
- Status last verified
- Aug 2021
- First submitted
- 4 Jan 2019
- Last updated
- 31 Aug 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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)
- ClinicalTrials.gov ID
- NCT03795012
- Acronym / sponsor ID
- MedOPP167
- Conditions
- Breast Cancer
- Keywords
- breast cancer, Unresectable, ER, PR, Her2, recurrent, metastatic
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Slow recruitment rate
- Enrolment
- 22 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Study start
- 30 Apr 2019 (actual)
- Primary completion
- 31 Mar 2021 (actual)
- Study completion
- 31 Mar 2021 (actual)
- First posted
- 7 Jan 2019 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Eribulin monotherapy | Active comparator | Drug: EribulinPatients will receive eribulin injections intravenously on days 1 and 8 of every 21- day cycle |
| eribulin plus endocrine therapy | Active comparator | Drug: EribulinPatients 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- 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.
Key exclusion criteria (11 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| EribulinAlso: HalavenPatients will receive eribulin injections intravenously on days 1 and 8 of every 21-day cycle alone. | Drug | Eribulin monotherapy, eribulin plus endocrine therapy |
Primary outcome
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.
7 secondary outcomes
The progression-free survival (PFS)
Time frame: Baseline up to 27 months
PFS-2, in the eribulin and the eribulin + ET arms
Time frame: Baseline up to 27 months
Overall response rate (ORR) in the eribulin arm
Time frame: Baseline up to 27 months
The duration of response (DOR) 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
Time frame: Baseline up to 27 months
The overall survival (OS) in the eribulin and the eribulin + ET arms
Time frame: Baseline up to 27 months
Maximum Tumor shrinkage
Time frame: Baseline up to 27 months
Results and safety
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Javier Cortés, PhD principal investigator
MedSIR
9 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Eribulin in people with Breast Cancer, run by MedSIR at 9 sites in Spain.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 14 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 31 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 sites in Spain. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study was stopped early (reason given: Slow recruitment rate). Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The overall response rate (ORR) (time frame: Baseline up to 27 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Aug 2021.