Can treatment with Eribulin chemotherapy restore the sentivity in cancertissue in subsequent treatment with antihormon treatment? A study for patients with ER positive, HER2 normal breast cancer.

Can Eribulin enhance the effect of subsequent endocrine therapy?- a phase 2 study for patients with ER positive HER2 normal metastatic breast cancer

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2020-004909-32-DK

Enrollment

Registered

2020-11-30

Start date

2021-02-16

Completion date

Unknown

Last updated

2024-11-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic breast cancer with estrogene positive and HER2 normal/negative subtype. MedDRA version: 20.0 Level: LLT Classification code 10027475 Term: Metastatic breast cancer System Organ Class: 100000004864

Interventions

Trade Name: Halaven Product Name: Halaven Pharmaceutical Form: Concentrate and solvent for solution for infusion INN or Proposed INN: Eribulin CAS Number: 441045-17-6 Other descriptive name: ERIBULIN

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: postmenopausal patient with ER positive, HER2 normal breastcancer progression on fulvestrant at least 18 years performance status at least 2 patients should be cancidates for eribulin treatment meassurable disease Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 25 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 17

Exclusion criteria

Exclusion criteria: previously treated with eribulin or examestane not candidate for eribulin treatment not abel to swallow the tablet of exemestane hepatic or renal dysfunction

Design outcomes

Primary

Measure	Time frame
Main Objective: Can we, by 4 series of chemoterapy treatment with Eribulin, enhance the effect of 3. line antiestrogenen treatment with exemestane, as compared to 2 linie anti-estrogene treatment with fulvestrant monoterapy (before entering the study). ;Secondary Objective: Differences in responserate and effect in different subgroups. Can we identify molecular changes in the tumortissue.;Primary end point(s): Comparison of time to treatment faliure for 2. (Fulvestrant) and 3. line (exemestane) endocrine treatment when 4 series of eribulin is given inbetween;Timepoint(s) of evaluation of this end point: Expected in 2025 at end of study	—

Measure

Time frame

Main Objective: Can we, by 4 series of chemoterapy treatment with Eribulin, enhance the effect of 3. line antiestrogenen treatment with exemestane, as compared to 2 linie anti-estrogene treatment with fulvestrant monoterapy (before entering the study). ;Secondary Objective: Differences in responserate and effect in different subgroups. Can we identify molecular changes in the tumortissue.;Primary end point(s): Comparison of time to treatment faliure for 2. (Fulvestrant) and 3. line (exemestane) endocrine treatment when 4 series of eribulin is given inbetween;Timepoint(s) of evaluation of this end point: Expected in 2025 at end of study

—

Secondary

Measure	Time frame
Secondary end point(s): calculate response rates for 4 series of eribulin calculate clinical benefit rate describe sideeffects describe changes in immunehistochemestry andmaybee changes in PAM50 subgroup;Timepoint(s) of evaluation of this end point: expected in 2025 at end of study	—

Countries

Denmark

Contacts

Public ContactDepartment of Oncology

Anne Sofie Brems-Eskildsen

annebrem@rm.dk4524839896

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026