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 @ 10:45 PM
Ignite Modification Date:
2025-12-24 @ 10:45 PM
NCT ID:
NCT03439735
Eligibility Criteria:
Inclusion Criteria:
* Male or Female
* 18 years or older
* Eastern Cooperative Oncology Group (ECOG) performance status of 0-2
* Metastatic (stage IV) breast cancer or locally advanced breast cancer
* Estrogen Receptor (ER) and/or Progesterone Receptor (PR) positive, HER2- negative
* Treatment naïve in metastatic or locally advanced setting and planning to undergo treatment with endocrine therapy (ET) and palbociclib OR receiving first-line ET and palbociclib for metastatic or locally advanced disease.
* Premenopausal women and men must be treated with concurrent luteinizing hormone-releasing hormone (LHRH) agonist as would be standard-of-care.
* Evaluable or measurable disease.
* Tissue from a metastatic site must be available within past 6 months prior to therapy initiation.
* Ability to give voluntary informed consent
Exclusion Criteria:
* Any pregnant or nursing woman
* No history of another primary malignancy within past 5 years. Patients with prior history of in situ cancer or basal or localized squamous cell skin cancer are eligible.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
100 Years
Study:
NCT03439735
Study Brief:
Protocol Section:
NCT03439735