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:
2025-12-25 @ 4:10 AM
Ignite Modification Date:
2025-12-25 @ 4:10 AM
NCT ID:
NCT02278120
Eligibility Criteria:
Key inclusion criteria:
* Patients had advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy
* Patients were premenopausal or perimenopausal at the time of study entry
* Patients who had received (neo) adjuvant therapy for breast cancer were eligible
* Patients had a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer
* Patients had HER2-negative breast cancer
* Patients must have either had measurable disease or If no measurable disease was present, then at least one predominantly lytic bone lesion
* Patients had an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Patients had adequate bone marrow and organ function
Key exclusion criteria:
* Patients who had received a prior CDK4/6 inhibitor
* Patients were postmenopausal
* Patients who currently had inflammatory breast cancer at screening.
* Patients who had received any prior hormonal anti-cancer therapy for advanced breast cancer, except for ≤ 14 days of tamoxifen or NSAI ± goserelin for advanced breast cancer prior to randomization.
* Patients had a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell skin carcinoma, squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer.
* Patients with CNS metastases.
* Patients had active cardiac disease or a history of cardiac dysfunction
* Patients were currently using other antineoplastic agents
* Patients were pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception.
Healthy Volunteers:
False
Sex:
FEMALE
Minimum Age:
18 Years
Maximum Age:
59 Years
Study:
NCT02278120
Study Brief:
Protocol Section:
NCT02278120