Overview

This trial is active, not recruiting.

Condition advanced, metastatic breast cancer
Treatments lee011, tamoxifen, letrozole, anastrozole, goserelin, lee011 placebo
Phase phase 3
Targets CDK4, CDK6
Sponsor Novartis Pharmaceuticals
Start date November 2014
End date February 2018
Trial size 671 participants
Trial identifier NCT02278120, CLEE011E2301

Summary

This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer.

United States California, Illinois, Kansas, Maryland, Massachusetts, New Mexico, New York, North Dakota, and Texas
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, caregiver, investigator, outcomes assessor)
Primary purpose treatment
Arm
(Experimental)
LEE011 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
lee011
LEE011 600 mg daily oral
tamoxifen
tamoxifen 20 mg daily oral
letrozole
letrozole 2.5 mg daily oral
anastrozole
anastrozole 1 mg daily oral
goserelin
Goserelin 3.6 mg subcutaneous injection
(Placebo Comparator)
LEE011 Placebo 600 mg daily oral (3 weeks on/ 1 week off) in combination with NSAI or tamoxifen (tamoxifen 20 mg daily oral or letrozole 2.5 mg daily oral or anastrozole 1 mg daily oral) and goserelin 3.6 mg subcutaneous injection (once every 28 days)
tamoxifen
tamoxifen 20 mg daily oral
letrozole
letrozole 2.5 mg daily oral
anastrozole
anastrozole 1 mg daily oral
goserelin
Goserelin 3.6 mg subcutaneous injection
lee011 placebo
LEE011 placebo 600 mg daily oral

Primary Outcomes

Measure
Progression Free Survival (PFS)
time frame: Up to approximatley 25 months

Secondary Outcomes

Measure
Overall survival (OS)
time frame: Up to approximately 69 months
Clinical Benefit Rate (CBR)
time frame: Up to approximately 25 months
Safety and Tolerability of LEE011
time frame: Up to approximately 26 months
Time to Response (TTR)
time frame: Up to approximately 25 months
Duration of Response (DOR)
time frame: Up to approximately 25 months
Time to definitive deterioration of the ECOG PS from baseline
time frame: Baseline, up to approximately 25 months
Time to 10% deterioration in the global health status/QOL scale score of the EORTC QLQ-C30
time frame: Up to approximately 25 months
Change from baseline in the global health status/QOL scale score of the EORTC QLQ-C30
time frame: Up to approximately 25 months
Overall Response Rate (ORR)
time frame: Up to approximately 25 months

Eligibility Criteria

Female participants from 18 years up to 59 years old.

Inclusion Criteria: - Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy - Patient is premenopausal or perimenopausal at the time of study entry - Patients who received (neo) adjuvant therapy for breast cancer are eligible - Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer - Patient has HER2-negative breast cancer - Patient must have either measurable disease or If no measurable disease is present, then at least one predominantly lytic bone lesion - Patient has an Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 - Patient has adequate bone marrow and organ function Exclusion Criteria: - Patient who has received a prior CDK4/6 inhibitor - Patient is postmenopausal - Patients who currently have inflammatory breast cancer at screening. - Patients who 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. - Patient has 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. - Patient with CNS metastases. - Patient has active cardiac disease or a history of cardiac dysfunction - Patient is currently using other antineoplastic agents - Patient is pregnant or nursing or physiologically capable of becoming pregnant and not using highly effective contraception

Additional Information

Official title A Phase III Randomized, Double-blind, Placebo-controlled Study of LEE011 or Placebo in Combination With Tamoxifen and Goserelin or a Non-steroidal Aromatase Inhibitor (NSAI) and Goserelin for the Treatment of Premenopausal Women With Hormone Receptor Positive, HER2-negative, Advanced Breast Cancer
Description The purpose of this study is to assess the efficacy of LEE011, as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer
Trial information was received from ClinicalTrials.gov and was last updated in September 2016.
Information provided to ClinicalTrials.gov by Novartis.