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 @ 4:43 PM
Ignite Modification Date:
2025-12-24 @ 4:43 PM
NCT ID:
NCT03703466
Eligibility Criteria:
Inclusion Criteria:
* Have a diagnosis of HR+, HER2- metastatic breast cancer (mBC).
* Have all of the following:
* Recurrent, locally advanced, unresectable or mBC with disease progression following anti-estrogen therapy.
* Prior treatment with chemotherapy for locally advanced or metastatic disease.
* No prior treatment with cyclin-dependent kinases (CDK) 4 and 6 inhibitor.
* Have Eastern Cooperative Oncology Group performance status (ECOG PS) ≤1.
* Have discontinued all previous treatments for cancer and recovered from the acute effects of therapy.
* Have adequate organ function.
* Women of child-bearing potential must have a negative pregnancy test.
* Are able to swallow tablets/capsules.
Exclusion Criteria:
* Are currently receiving treatment in a clinical study involving an investigational product.
* Have a serious concomitant systemic disorder.
* Have symptomatic central nervous system (CNS) malignancy or metastasis.
* Have a symptomatic Human Immunodeficiency Virus (HIV) infection or symptomatic activated/reactivated hepatitis A, B, or C.
* Have a personal history of syncope of either unexplained or cardiovascular etiology, ventricular tachycardia, ventricular fibrillation, or sudden cardiac arrest.
* Have a history of any other cancer.
* Had major surgery within 14 days prior to randomization.
* Are breastfeeding.
* Have received treatment with a drug that has not received regulatory approval for any indication within 14 or 21 days of the initial dose of study drug for a nonmyelosuppressive or myelosuppressive agent, respectively.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT03703466
Study Brief:
Protocol Section:
NCT03703466