Ribociclib and Letrozole Treatment in Ovarian Cancer
- Conditions
- Low Grade Serous Carcinoma
- Interventions
- Registration Number
- NCT03673124
- Lead Sponsor
- Gynecologic Oncology Group
- Brief Summary
The study evaluates the response to treatment with Ribociclib and Letrozole in patients with low grade serous cancer of the ovary, fallopian tube or peritoneum.
- Detailed Description
Ribociclib (formerly LEE011) is an orally bioavailable, highly selective small molecule inhibitor of cyclin-dependent kinases 4 and 6 (CDK4/6). Ribociclib has been approved by the United States Food and Drug Administration (U.S. FDA) and the European Commission as an initial endocrine-based therapy for the treatment of postmenopausal women with hormone receptor (HR)-positive, human epidermal growth factor receptor 2 (HER2)-negative advanced or metastatic breast cancer in combination with an aromatase inhibitor based on a randomized, double-blind, placebo-controlled, international clinical trial (MONALEESA-2). Additional marketing authorizations are under review by health authorities. Additional phase III clinical trials for the treatment of hormone receptor positive (HR+) breast cancer patients, as well as several other phase I or II clinical studies are being conducted.
Letrozole is a highly potent, orally active non-steroidal competitive inhibitor of the aromatase enzyme system. It effectively inhibits the conversion of androgens to estrogens both in vitro and in vivo. It is indicated both as first-line treatment of postmenopausal women with hormone receptor positive or hormone receptor unknown locally advanced or metastatic breast cancer as well as for the treatment of advanced breast cancer in postmenopausal women with disease progression following antiestrogen therapy.
Based on encouraging results in women with advanced hormone-receptor-positive breast cancer, a clinical trial for women with recurrent low-grade serous carcinoma is warranted. Furthermore, such a trial would have great appeal to women with recurrent low-grade serous carcinoma, a cohort with limited therapeutic options. Although low-grade serous carcinoma is a rather uncommon histologic subtype, prolonged overall survival results in a relatively high prevalence.
Recruitment & Eligibility
- Status
- ACTIVE_NOT_RECRUITING
- Sex
- Female
- Target Recruitment
- 51
Not provided
Not provided
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- SINGLE_GROUP
- Arm && Interventions
Group Intervention Description Ribociclib and letrozole Letrozole Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily Ribociclib and letrozole Ribociclib Ribociclib 600mg oral daily for 3 weeks then 1 week off plus Letrozole 2.5 mg oral daily
- Primary Outcome Measures
Name Time Method Response rate From date of protocol entry to date of first documented response assessed up to 5 years Determine the response rate of patients receiving the combination of Ribociclib and Letrozole
- Secondary Outcome Measures
Name Time Method Clinical benefit (CR, PR, SD) rate From date of protocol entry to first documented response assessed up to 5 years Determine the clinical benefit (CR, PR, and SD) rate of patients receiving the combination of letrozole + Ribociclib.
Progression-free survival From date of protocol entry to date of first documented progression or death assessed up to 5 years determine the progression-free survival of women receiving the combination of letrozole + Ribociclib.
Overall survival From date of protocol entry to date of first documented progression or death assessed up to 5 years determine the overall survival of women receiving the combination of letrozole + Ribociclib.
Toxicity assessment (nature, frequency, and maximum degree of toxicity) every 4 weeks assessed up to 5 years determine the nature, frequency, and maximum degree of toxicity associated with this combination using CTCAE v5.0
Trial Locations
- Locations (27)
Northside Hospital
đşđ¸Atlanta, Georgia, United States
Saint Vincent Hospital and Health Care Center, Inc.
đşđ¸Indianapolis, Indiana, United States
The Ohio State Comprehensive Cancer Center
đşđ¸Columbus, Ohio, United States
Memorial Hermann Texas Medical Center - Texas Medical Center
đşđ¸Houston, Texas, United States
MD Anderson Cancer Center
đşđ¸Houston, Texas, United States
Houston Methodist Willowbrook Hospital
đşđ¸Houston, Texas, United States
University of California, San Francisco
đşđ¸San Francisco, California, United States
Western Pennsylvania Hospital/West Penn Hospital
đşđ¸Pittsburgh, Pennsylvania, United States
The Valley Hospital Inc.
đşđ¸Ridgewood, New Jersey, United States
New Mexico Cancer Care Alliance/University of New Mexico Comprehensive Cancer Center
đşđ¸Albuquerque, New Mexico, United States
Miami Valley Hospital
đşđ¸Centerville, Ohio, United States
Parkland Health and Hospital System
đşđ¸Dallas, Texas, United States
University of Texas Southwestern Medical Center
đşđ¸Dallas, Texas, United States
Abington Memorial Hospital
đşđ¸Willow Grove, Pennsylvania, United States
Houston Methodist Sugar Land Hospital
đşđ¸Sugar Land, Texas, United States
NorthShore University HealthSystem
đşđ¸Evanston, Illinois, United States
Southwest Gynecologic Oncology Associates
đşđ¸Albuquerque, New Mexico, United States
Oklahoma Cancer Care Specialists and Research Institute , LLC
đşđ¸Tulsa, Oklahoma, United States
Houston Methodist Hospital
đşđ¸Houston, Texas, United States
Hackensack University Medical Center
đşđ¸Hackensack, New Jersey, United States
Dartmouth-Hitchcock Medical Center
đşđ¸Lebanon, New Hampshire, United States
Women & Infants Hospital
đşđ¸Providence, Rhode Island, United States
UF Heath
đşđ¸Gainesville, Florida, United States
St. Joseph Mercy Hospital Cancer Care Center
đşđ¸Ann Arbor, Michigan, United States
Mayo Clinic - Rochester
đşđ¸Rochester, Minnesota, United States
University of Oklahoma Health Sciences Center
đşđ¸Oklahoma City, Oklahoma, United States
Moffitt Cancer Center
đşđ¸Tampa, Florida, United States