Status:
COMPLETED
Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer
Lead Sponsor:
Novartis Pharmaceuticals
Conditions:
Advanced Metastatic Breast Cancer
Eligibility:
FEMALE
18-59 years
Phase:
PHASE3
Brief Summary
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 tr...
Detailed Description
This was a randomized, Phase III, double-blind, global study comparing the treatment efficacy and safety of ribociclib + goserelin + tamoxifen or a NSAI (letrozole or anastrozole) versus placebo + gos...
Eligibility Criteria
Inclusion
- 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.
Exclusion
Key Trial Info
Start Date :
November 20 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 20 2023
Estimated Enrollment :
672 Patients enrolled
Trial Details
Trial ID
NCT02278120
Start Date
November 20 2014
End Date
April 20 2023
Last Update
March 12 2024
Active Locations (183)
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1
Comprehensive Blood and Cancer SC-2
Bakersfield, California, United States, 93309
2
University Of California Los Angeles Dept of Onc
Los Angeles, California, United States, 90095
3
Comprehensive Cancer Center at Saint Joseph Hospital SC
Denver, Colorado, United States, 80218
4
Danbury Hospital SC
Danbury, Connecticut, United States, 06810