Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:02 PM
Ignite Modification Date:
2025-12-24 @ 4:02 PM
NCT ID:
NCT04478266
Eligibility Criteria:
Inclusion criteria :
* Adult participants with loco-regional recurrent or metastatic disease not amenable to curative treatment.
* Confirmed diagnosis of ER+/HER2- breast cancer.
* No prior systemic treatment for loco-regional recurrent or metastatic disease.
* Measurable disease evaluable per Response Evaluation Criterion in Solid Tumors (RECIST) v.1.1 or non-measurable bone-only disease.
* Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
* Participants should be willing to provide tumor tissue.
* Capable of giving informed consent.
Exclusion criteria:
* Known active brain metastases.
* Prior neo (adjuvant) treatment with any selective estrogen receptor degrader (SERD).
* Inadequate organ and marrow function.
* Disease recurrence while on, or within 12 months of completion of (neo)adjuvant endocrine therapy.
* Pregnant, breastfeeding, or woman of childbearing potential unwilling to use recommended contraception methods.
* Male participants who disagree to follow contraception.
* Participants with advanced, symptomatic visceral spread, that are at risk of life-threatening complications in the short term.
* Participants with significant concomitant illness.
The above information was not intended to contain all considerations relevant to a participant's potential participation in a clinical trial.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT04478266
Study Brief:
Protocol Section:
NCT04478266