Health Condition 1: null- The study will include with HR positive advance breast cancer
Conditions
Interventions
Intervention1: LEE011 plus Tamoxifen or NSAI plus Goserelin: LEE011 (600mg() plus Tamoxifen or NSAI plus Goserelin. Duration of treatment is 40 months
Control Intervention1: LEE011 matching placebo pl
Sponsors
Novartis Healthcare Pvt Ltd
Eligibility
Inclusion criteria
Inclusion criteria: 1) Patient is an adult, female = 18 years old and 2) Confirmed negative serum pregnancy test (ß-hCG) within 72 hours before starting study treatment 3) Patient is pre-menopausal or peri-menopausal at the time of study entry. 4)Patient has advanced (locoregionally recurrent or metastatic) breast cancer not amenable to curative therapy (e.g. surgery and/or radiotherapy). 5) Patients who received (neo) adjuvant therapy for breast cancer are eligible 6) Patients who received = 14 days of tamoxifen or a NSAI (letrozole or anastrozole) with or without goserelin for advanced breast cancer prior to randomization are eligible. Patients must continue treatment with the same hormonal agent + goserelin during the study. No treatment interruption is required for these patients prior to randomization. 7) Patients who have received up to 1 line of chemotherapy for advanced breast cancer and have been discontinued at least 28 days before randomization are eligible. 8)Patient has a histologically and/or cytologically confirmed diagnosis of estrogen-receptor positive and/or progesterone receptor positive breast cancer by local laboratory (based on most recently analyzed biopsy) 9)Patient has HER2-negative breast cancer (based on most recently analyzed biopsy) defined as a negative in situ hybridization test or an IHC status of 0,1 or 2. If IHC is 2, a negative in situ hybridization (FISH, CISH, or SISH) test is required by local laboratory testing. 10)Patient must have either: o Measurable disease, i.e., at least one measurable lesion as per RECIST 1.1 criteria. OR If no measurable disease is present, then at least one predominantly lytic bone lesion must be present (patients with no measurable disease and only one predominantly lytic bone lesion that has been previously irradiated are eligible if there is documented evidence of disease progression of the bone lesion after irradiation) 11)Patient has an ECOG PS 0 or 1. 12)Patient has adequate bone marrow
Exclusion criteria
Exclusion criteria: 1) Patient who has received a prior CDK4/6 inhibitor. 2) Patient has a known hypersensitivity to any of the excipients of LEE011,tamoxifen, NSAI (letrozole or anastrozole), or goserelin. 3)Patient is post-menopausal 4)Patients who currently have inflammatory breast cancer at screening. 5)Patients who received any prior hormonal anti-cancer therapy for advanced breast cancer except for = 14 days of tamoxifen or a NSAI ± goserelin for advanced breast cancer prior to randomization. 6) Patient who has not had resolution of all acute toxic effects of prior anti-cancer therapy to NCI CTCAE version 4.03 Grade =1 (except alopecia or other toxicities not considered a safety risk for the patient at investigators discretion 7)Patient has a concurrent malignancy or malignancy within 3 years of randomization, with the exception of adequately treated basal cell carcinoma,squamous cell skin carcinoma, non-melanomatous skin cancer or curatively resected cervical cancer. 8)Patient with CNS metastases. 9)Patient has impairment of gastrointestinal (GI) function or GI disease that may
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1) To determine whether treatment with tamoxifen or a NSAI + goserelin + LEE011 prolongs PFS compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with HR+, HER2- negative advanced breast cancer 2) To determine whether treatment with tamoxifen or a NSAI + goserelin + LEE011 prolongs OS compared to treatment with tamoxifen or a NSAI + goserelin + placebo in premenopausal women with HR+, HER2- negative advanced breast cancer.Timepoint: PFS timepoint: 22 months or 329 events globally. OS timepoint: 40 months or 252 events | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the two treatment arms with respect to time to deterioration of ECOG PSTimepoint: Time to definitive deterioration of the ECOG PS from baseline | — |
Countries
Argentina, Australia, Belgium, Brazil, Bulgaria, Canada, China, Colombia, France, Germany, Greece, Hong Kong, Hungary, India, Italy, Japan, Lebanon, Mexico, Poland, Republic of Korea, Russian Federation, Saudi Arabia, Singapore, Slovakia, Spain, Switzerland, Taiwan, Thailand, Turkey, United Arab Emirates, United States of America
Contacts
Public ContactDr Manish Mistry
Novartis India Limited
Outcome results
None listed