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:
2026-03-26 @ 3:18 PM
Ignite Modification Date:
2026-03-26 @ 3:18 PM
NCT ID:
NCT07340658
Eligibility Criteria:
Inclusion Criteria:
* Female participants with inoperable locally advanced or metastatic breast cancer.
* Confirmed diagnosis of HR-positive/HER2-negative breast cancer.
* Postmenopausal woman.
* Previously untreated with any systemic anticancer therapy for their locoregionally recurrent or metastatic HR-positive disease. Participants may have received cytotoxic chemotherapy within (neo) adjuvant previous treatment of breast cancer but must show progressive disease prior to enrolment.
* Have either measurable disease or non-measurable bone-only disease.
* ECOG performance status 0-2.
* Adequate organ and marrow function.
* Resolution of all acute toxic effects of prior anticancer therapy or surgical procedures to NCI Common Terminology Criteria for Adverse Events (CTCAE) version 5.0 Grade ≤ 1 (except alopecia or other toxicities not considered a safety risk for the participant at the investigator's discretion).
* BMI ≥ 19 and ≤ 39 kg/m2.
Exclusion Criteria:
* Participants with advanced, symptomatic, visceral spread who are at risk of life-threatening complications in the short term.
* Known uncontrolled or symptomatic central nervous system (CNS) metastases.
* Concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer.
* Active cardiac disease or a history of cardiac dysfunction.
* Uncontrolled hypertension.
* History of symptomatic vertebral fragility fracture or any fragility fracture of the hip, pelvis, wrist, or other location (defined as any fracture without a history of trauma or because of a fall from standing height or less, excluding fingers, toes, face and skull).
* Presence of medical conditions associated with low bone mass.
* Presence of detectable viral infection, including HBV, HCV, and HIV. Screening is not required for enrollment. Note: Participants who have been effectively treated and have a sustained virologic response are eligible for enrollment.
* Major surgery, chemotherapy, radiotherapy, any investigational agents, or other anticancer therapy within 14 days (2 weeks) before randomization. Participants who received prior radiotherapy to \> 25% of bone marrow are not eligible independent of when it was received.
* Bisphosphonates or receptor activator of nuclear factor kappa-β ligand (RANKL) inhibitors initiated or have their dose changed within 14 days prior to randomization, i.e., participants should be on stable dose treatment for at least 14 days prior to randomization.
* Use of estrogen or progesterone hormone replacement therapy, oral contraceptives, androgens, LHRH analogs, prolactin inhibitors, or antiandrogens within 3 months prior to randomization.
* Use of the following medications within the three previous days or a period of 5 half-lives, whichever is longer prior to randomization:
1. Any medications including St. John's wort, known to be potent or moderate inducers of Cytochrome P450 (CYP) 3A.
2. Any medications or products known to be potent or moderate inhibitors of CYP3A (e.g., grapefruit juice).
3. Any medications known to be inducers of CYP2A6.
4. Any medications known to be inhibitors of CYP2A6.
* Concurrently use of other anticancer therapy.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Study:
NCT07340658
Study Brief:
Protocol Section:
NCT07340658