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.
Phase 1
- Conditions
- Metastatic breast cancer with estrogene positive and HER2 normal/negative subtype.MedDRA version: 20.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2020-004909-32-DK
- Lead Sponsor
- Department of Oncology
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Authorised-recruitment may be ongoing or finished
- Sex
- Female
- Target Recruitment
- 42
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
previously treated with eribulin or examestane
not candidate for eribulin treatment
not abel to swallow the tablet of exemestane
hepatic or renal dysfunction
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method