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Brief Title: HR+/HER2- Advanced Breast Cancer and Endocrine Resistance
Official Title: A Phase 2, International, Multicenter, Open-labeled, Randomized Trial of PAlbociclib and Fulvestrant vs. Standard Oral Capecitabine In Patients With Hormone Receptor (HR)+ / HER2- Advanced Breast Cancer and Documented Endocrine Resistance
Study ID: NCT03322215
Brief Summary: This is a randomized, 2-arm, open-label, multicenter, international phase II trial. A total of 196 patients will be included. The study will include patients with metastatic Hormone Receptor positive / Human Epidermal Growth Factor Receptor (HER2) negative breast cancer with progressive disease after endocrine treatment. Patients will be randomized (1:1) between two treatment arms: A. palbociclib + fulvestrant and b. capecitabine.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Sahlgrenska University Hospital, Göteborg, , Sweden
Skåne University Hospital, Malmö, , Sweden
S:t Görans Hospital, Stockholm, , Sweden
Karolinska University Hospital, Stockholm, , Sweden
Uppsala University Hospital, Uppsala, , Sweden
NHS Grampian, Aberdeen, , United Kingdom
Western General Hospital, Edinburgh, , United Kingdom
Beatson, Glasgow, , United Kingdom
NHS Ayshire and Arran, Kilmarnock, , United Kingdom