Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Canc… (NCT03795012) | Clinical Trial Compass
TerminatedPhase 2
Trial With Eribulin or Eribulin+ Endocrine Therapy in Locally-recurrent or Metastatic Breast Cancer Patients
Stopped: Slow recruitment rate
Spain22 participantsStarted 2019-04-30
Plain-language summary
Unresectable, ER-positive and/or PR-positive and HER2-negative locally-recurrent or metastatic breast cancer (mBC).
Who can participate
Age range18 Years
SexFEMALE
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 …