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Brief Title: Fulvestrant and Ipatasertib for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
Official Title: Double-Blind Placebo-Controlled Randomized Phase III Trial of Fulvestrant and Ipatasertib as Treatment for Advanced HER-2 Negative and Estrogen Receptor Positive (ER+) Breast Cancer Following Progression on First Line CDK 4/6 Inhibitor and Aromatase Inhibitor
Study ID: NCT04650581
Brief Summary: The purpose of this study is to find out whether a new drug, Ipatasertib, can slow the growth of advanced breast cancer when added to standard therapy (Fulvestrant).
Detailed Description: Patients enrolled in this study will receive either Ipatasertib plus Fulvestrant or placebo (a substance that looks like the study drug but does not have any active or medicinal ingredient) plus Fulvestant. The study will provide information about the ability of Ipatasertib plus Fulvestrant to control the cancer, the side effects and safety of the treatment, how patients feel while taking the treatment and associated costs.
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Southern Highlands Cancer Centre, Bowral, New South Wales, Australia
Lake Macquarie Private Hospital, Gateshead, New South Wales, Australia
Gosford Hospital, Gosford, New South Wales, Australia
Macquarie University Hospital, Macquarie University, New South Wales, Australia
Shoalhaven Cancer Care Centre, Nowra, New South Wales, Australia
Sunshine Coast University Hospital, Birtinya, Queensland, Australia
Toowoomba Hospital, Toowoomba, Queensland, Australia
Victorian Breast and Oncology Care, East Melbourne, Victoria, Australia
The Northern Hospital, Epping, Victoria, Australia
Frankston Hospital, Frankston, Victoria, Australia
Alfred Hospital, Melbourne, Victoria, Australia
Sunshine Hospital, St. Albans, Victoria, Australia
St John of God Bunbury, Bunbury, Western Australia, Australia
Fiona Stanley Hospital, Murdoch, Western Australia, Australia
Canberra Hospital, Garran, , Australia
Royal Brisbane and Womens Hospital, Herston, , Australia
BCCA - Cancer Centre for the Southern Interior, Kelowna, British Columbia, Canada
BCCA - Fraser Valley Cancer Centre, Surrey, British Columbia, Canada
BCCA - Vancouver Cancer Centre, Vancouver, British Columbia, Canada
Regional Health Authority B, Zone 2, Saint John, New Brunswick, Canada
QEII Health Sciences Centre, Halifax, Nova Scotia, Canada
Royal Victoria Regional Health Centre, Barrie, Ontario, Canada
William Osler Health System, Brampton, Ontario, Canada
Juravinski Cancer Centre at Hamilton Health Sciences, Hamilton, Ontario, Canada
Kingston Health Sciences Centre, Kingston, Ontario, Canada
London Regional Cancer Program, London, Ontario, Canada
Stronach Regional Health Centre at Southlake, Newmarket, Ontario, Canada
Ottawa Hospital Research Institute, Ottawa, Ontario, Canada
Algoma District Cancer Program, Sault Ste. Marie, Ontario, Canada
Thunder Bay Regional Health Sciences Centre/, Thunder Bay, Ontario, Canada
University Health Network, Toronto, Ontario, Canada
Windsor Regional Cancer Centre, Windsor, Ontario, Canada
Centre Integre de Sante et de Services Sociaux, Greenfield Park, Quebec, Canada
CHUM-Centre Hospitalier de l'Universite de Montreal, Montreal, Quebec, Canada
CHA-Hopital Du St-Sacrement, Quebec City, Quebec, Canada
Allan Blair Cancer Centre, Regina, Saskatchewan, Canada
Saskatoon Cancer Centre, Saskatoon, Saskatchewan, Canada
Auckland City Hospital, Auckland, , New Zealand
Wellington Cancer Centre, Wellington Hospital, Wellington, , New Zealand
Name: Stephen Chia
Affiliation: BCCA - Vancouver Cancer Centre, BC Canada
Role: STUDY_CHAIR