๐Ÿ›๏ธ Verified NIH Record โ€ข Updated 2026-03-23

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 (NCT04650581)

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

๐Ÿ”ต Active, Not Recruiting Phase3 ๐Ÿ’Š Investigational Drug / Biologic Sponsor: Canadian Cancer Trials Group

๐Ÿฉบ Plain-English Summary (8th-Grade Level)

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).

Who can join: Review the eligibility criteria below.

Location: Southern Highlands Cancer Centre โ€” Bowral, New South Wales

Age range: 18 Years

๐Ÿงช Interventions in This Study

๐Ÿ“‹ "Do I Qualify?" โ€” 1-Minute Self Screener

Instant Checklist

Full eligibility criteria are available on the official NIH protocol. View the criteria โ†—

๐Ÿ“ All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

  • Southern Highlands Cancer Centre โ€” Bowral, New South Wales
  • Lake Macquarie Private Hospital โ€” Gateshead, New South Wales
  • Gosford Hospital โ€” Gosford, New South Wales
  • Macquarie University Hospital โ€” Macquarie University, New South Wales
  • Shoalhaven Cancer Care Centre โ€” Nowra, New South Wales
  • Sunshine Coast University Hospital โ€” Birtinya, Queensland
  • Toowoomba Hospital โ€” Toowoomba, Queensland
  • Victorian Breast and Oncology Care โ€” East Melbourne, Victoria
  • The Northern Hospital โ€” Epping, Victoria
  • Frankston Hospital โ€” Frankston, Victoria
  • Alfred Hospital โ€” Melbourne, Victoria
  • Sunshine Hospital โ€” St Albans, Victoria
  • St John of God Bunbury โ€” Bunbury, Western Australia
  • Fiona Stanley Hospital โ€” Murdoch, Western Australia
  • Canberra Hospital โ€” Garran,
  • Royal Brisbane and Womens Hospital โ€” Herston,
  • BCCA - Cancer Centre for the Southern Interior โ€” Kelowna, British Columbia
  • BCCA - Fraser Valley Cancer Centre โ€” Surrey, British Columbia
  • BCCA - Vancouver Cancer Centre โ€” Vancouver, British Columbia
  • Regional Health Authority B, Zone 2 โ€” Saint John, New Brunswick
  • QEII Health Sciences Centre โ€” Halifax, Nova Scotia
  • Royal Victoria Regional Health Centre โ€” Barrie, Ontario
  • William Osler Health System โ€” Brampton, Ontario
  • Juravinski Cancer Centre at Hamilton Health Sciences โ€” Hamilton, Ontario
  • Kingston Health Sciences Centre โ€” Kingston, Ontario

๐Ÿ’ฐ Cost, Insurance & Patient Rights

  • 100% Free Items: The investigational treatment and protocol-required procedures are supplied at zero cost by the sponsor.
  • Routine Patient Care: Under federal law (ACA ยง 2709) and many state statutes, routine care costs are covered during participation.
  • Voluntary Participation: You may withdraw at any time without affecting your standard medical care.

Explore by condition: All Breast Cancer clinical trials

๐Ÿ’ก How to Participate

  1. Check the checklist above to see if you may qualify.
  2. Review the official NIH record below to find the coordinating site.
  3. Ask about the visit schedule, what is covered at no cost, and any travel support.
  4. Confirm with your own doctor before making a decision.
๐Ÿ›๏ธ View Official NIH Record โ†—