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Spots Global Cancer Trial Database for 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

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Trial Identification

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

Conditions

Breast Cancer

Study Description

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.

Keywords

Eligibility

Minimum Age: 18 Years

Eligible Ages: ADULT, OLDER_ADULT

Sex: ALL

Healthy Volunteers: No

Locations

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

Contact Details

Name: Stephen Chia

Affiliation: BCCA - Vancouver Cancer Centre, BC Canada

Role: STUDY_CHAIR

Useful links and downloads for this trial

Clinicaltrials.gov

Google Search Results

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