๐๏ธ Verified NIH Record โข 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
๐ต Active, Not Recruiting Phase3 ๐ Investigational Drug / Biologic Sponsor: Canadian Cancer Trials Group
๐ฉบ 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
๐งช Interventions in This Study
๐ "Do I Qualify?" โ 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria โ
๐ 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
๐ฐ 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.
More studies in Breast Cancer
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- [177Lu]Lu-NeoB in Combination With Ribociclib and Fulvestrant in Participants With ER+, HER2- and GRPR+ Advanced Breast Cancer โ Los Angeles, California
- Evaluation And Risk Assessment For Persistent Postsurgical Pain After Breast Surgery โ Durham, North Carolina
- TACTIVE-U: A Study to Learn About the Study Medicine (Vepdegestrant) When Given With Other Medicines in People With Advanced or Metastatic Breast Cancer (Sub-Study B) โ Palo Alto, California
- A Multi Modality Surveillance Program for Women At High Risk for Breast Cancer โ Chicago, Illinois
- ATOP TRIAL: T-DM1 in HER2 Positive Breast Cancer โ Duarte, California
Explore by condition: All Breast Cancer clinical trials
๐ก How to Participate
- Check the checklist above to see if you may qualify.
- Review the official NIH record below to find the coordinating site.
- Ask about the visit schedule, what is covered at no cost, and any travel support.
- Confirm with your own doctor before making a decision.