Education and Training
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
The purpose of this study was to determine whether treatment with tamoxifen or a non-steroidal aromatase inhibitors (NSAI) + goserelin + LEE011 prolonged progression-free survival (PFS) compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with hormone receptor positive (HR+), human epidermal growth factor receptor 2 negative (HER2-) advanced breast cancer.
Stanford is currently not accepting patients for this trial.
Intervention(s):
- drug: Goserelin
- drug: Anastrozole
- drug: Tamoxifen
- drug: Letrozole
- drug: Ribociclib
- drug: Placebo
Eligibility
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.
Ages Eligible for Study
18 Years - 59 Years
Genders Eligible for Study
Female
Not currently accepting new patients for this trial
Contact Information
Stanford University
School of Medicine
300 Pasteur Drive
Stanford,
CA
94305
Janet Pan
650-723-0628
Not Recruiting