Spots Global Cancer Trial Database for Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
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Trial Identification
Brief Title: Two Different Schedules of Palbociclib + Second Line Endocrine Therapy in Estrogen Receptor Positive, HER2 Neg Advanced/Metastatic Breast Cancer
Official Title: Randomized Phase II Study Comparing Two Different Schedules of Palbociclib Plus Second Line Endocrine Therapy in Women With Estrogen Receptor Positive, HER2 Negative Advanced/Metastatic Breast Cancer
Study ID: NCT02630693
Conditions
Study Description
Brief Summary: The purpose of this study is to determine if the combination of endocrine therapy and Palbociclib at a daily dose of 100 mg will result in a better response to therapy with fewer dose interruptions than the proposed dosing regimen of 125 mg daily for 21 days out of a 28 day cycle in combination with endocrine therapy.
Detailed Description: The standard or usual treatment of this type of breast cancer is endocrine therapy. Palbociclib is a new type of drug for breast cancer. Laboratory tests as well as studies in animals and people show that it may help slow the growth of breast cancer. The most widely tested regimen of Palbociclib for patients with metastatic/advanced breast cancer is 125 mg every day for 21 days out of a 28 day cycle in combination with standard endocrine (hormone) therapy. This study explores if administering a lower dose of palbociclib - 100 mg given every day of a 28 day cycle in combination with standard endocrine (hormone) therapy - may result in more tumour shrinkage and be better tolerated.
Keywords
Eligibility
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: FEMALE
Healthy Volunteers: No
Locations
Cross Cancer Institute, Edmonton, Alberta, Canada
BCCA - Abbotsford Centre, Abbotsford, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
The Moncton Hospital, Moncton, New Brunswick, Canada
Dr. H. Bliss Murphy Cancer Centre, St. John's, Newfoundland and Labrador, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Cancer Centre of Southeastern Ontario at Kingston, Kingston, Ontario, Canada
Stronach Regional Health Centre at Southlake, Newmarket, Ontario, Canada
Lakeridge Health Oshawa, Oshawa, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Niagara Health System, St. Catharines, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
CHUM - Hopital Notre-Dame, Montreal, Quebec, Canada
The Jewish General Hospital, Montreal, Quebec, Canada
Hopital du Sacre-Coeur de Montreal, Montreal, Quebec, Canada
CHA-Hopital Du St-Sacrement, Quebec City, Quebec, Canada
Centre hospitalier universitaire de Sherbrooke, Sherbrooke, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Contact Details
Name: Anil A. Joy
Affiliation: Cross Cancer Institute, Edmonton Alberta Canada
Role: STUDY_CHAIR
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