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)

🧪 Interventions in This Study

• Ipatasertib (DRUG)
• Fulvestrant (DRUG)

Check every box below. If you can check all of them, you may meet the study's basic screening requirements (final eligibility is confirmed by the site team).

1. Histologically and/or cytologically confirmed ER positive, HER-2 negative breast cancer
2. Female patients must be post-menopausal; female patients who are pre-menopausal must have ovarian suppression using LHRH agonist while on study
3. Clinical and/or radiographic progression during treatment with or within 28 days after discontinuation of first line of treatment with a CDK 4/6 inhibitor and an aromatase inhibitor (AI) for advanced/metastatic disease
4. Evidence of clinically and/or radiologically documented disease
5. ≥ 18 years of age
6. ECOG performance status of 0 or 1
7. No concurrent anti-cancer therapy and must satisfy the following criteria for previous therapy
8. Must not have received more than one prior line of treatment with a CDK 4/6 inhibitor and an AI in the advanced disease setting.
9. Treatment with CDK 4/6 inhibitor and AI must have been the most recent treatment prior to registration for this study
10. Adequate hematology and organ function, in the absence of growth factors
11. Absolute neutrophils \> 1.5 x 10\^9/L
12. Platelets ≥ 100 x 10\^9/L

🔍 Extracted verbatim from the official NIH eligibility criteria. Always confirm with the study coordinator.

📍 All Participating Trial Locations (39 Sites)

Showing the first 25 of 39 sites.

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

💰 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 § 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.

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💡 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.