Study of Efficacy and Safety in Premenopausal Women With Hormone Receptor Positive, HER2-negative Advanced Breast Cancer

  • Interventional
  • Not Recruiting
  • NCT02278120
Eligibility Details Visit Clinicaltrials.gov

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

This is a multi-center, randomized, double-blinded, placebo controlled trial in pre-menopausal women with advanced breast cancer. The purpose of this study is to assess the efficacy of Ribociclib (LEE011), as measured by progression free survival (PFS), in premenopausal women with HR positive, HER2 negative advanced breast cancer

Gender
Female

Age Group
18 Years to 59 Years

Accepting Healthy Volunteers?
No

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

        Other protocol-defined Inclusion/Exclusion may apply.
  • Metastatic Cancer

At a Glance

National Government IDNCT02278120

IRB#IRB14-1375

Lead SponsorNovartis Pharmaceuticals

Lead PhysicianPhilip Charles Hoffman

Collaborator(s)N/A

EligibilityFemale
18 Years to 59 Years
Not Recruiting