Testing the Addition of Copanlisib to Usual Treatment (Fulvestrant and Abemaciclib) in Metastatic Breast Cancer (NCT03939897)
A Randomized Phase I/II Trial of Fulvestrant and Abemaciclib in Combination With Copanlisib (FAC) Versus Fulvestrant and Abemaciclib Alone (FA) for Endocrine-Resistant, Hormone Receptor Positive, HER2 Negative Metastatic Breast Cancer (FAC vs FA)
🩺 Plain-English Summary (8th-Grade Level)
This phase I trial studies the effects (good and bad) of adding copanlisib to the usual therapy of fulvestrant and abemaciclib in treating patients with hormone receptor positive and HER2 negative breast cancer that has spread from where it first started (breast) to other places in the body (metastatic). Some breast cancer cells have receptors for the hormones estrogen or progesterone. These cells are hormone receptor positive and they need estrogen or progesterone to grow. This can affect how the cancer is treated. Hormone therapy using fulvestrant may fight breast cancer by blocking the use of estrogen by the tumor cells. Abemaciclib and copanlisib may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. Adding copanlisib to the usual therapy of fulvestrant and abemaciclib may work better than giving fulvestrant and abemaciclib alone in treating patients with breast cancer.
Who can join: Review the eligibility criteria below.
Location: University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
Age range: 18 Years
🧪 Interventions in This Study
📋 "Do I Qualify?" — 1-Minute Self Screener
Instant ChecklistFull eligibility criteria are available on the official NIH protocol. View the criteria ↗
📍 All Participating Trial Locations (14 Sites)
- University of Alabama at Birmingham Cancer Center — Birmingham, Alabama
- UC Irvine Health Cancer Center-Newport — Costa Mesa, California
- UC Irvine Health/Chao Family Comprehensive Cancer Center — Orange, California
- University of Kentucky/Markey Cancer Center — Lexington, Kentucky
- Siteman Cancer Center at Saint Peters Hospital — City of Saint Peters, Missouri
- Siteman Cancer Center at West County Hospital — Creve Coeur, Missouri
- Washington University School of Medicine — St Louis, Missouri
- Siteman Cancer Center-South County — St Louis, Missouri
- Siteman Cancer Center at Christian Hospital — St Louis, Missouri
- Bellevue Hospital Center — New York, New York
- Laura and Isaac Perlmutter Cancer Center at NYU Langone — New York, New York
- Wake Forest University at Clemmons — Clemmons, North Carolina
- Wake Forest University Health Sciences — Winston-Salem, North Carolina
- Ohio State University Comprehensive Cancer Center — Columbus, Ohio
💰 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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Explore by condition: All Anatomic Stage IV Breast Cancer AJCC v8 clinical trials
💡 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.