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Ph I/II Fulvestrant & Abemaciclib in Combo w/ Copanlisib (FAC) HER2 Negative Met Breast Cancer

Ritesh Parajuli

A Study On:

  • Breast


  • Open



Interested in joining this trial?

Official Title

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)


This phase I/II 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 stage IV breast cancer. 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.


You can join if...

Inclusion Criteria:

  • Men and women must have histologically or cytologically confirmed ER and/or PR
    positive, HER2 negative or non-amplified breast cancer that is stage IV, with measurable
    or non-measurable disease.
  • No more than 1 prior chemotherapy in the metastatic setting. There is no limit on prior
    lines of endocrine therapy.

Exclusion Criteria:

  • Patients who have had chemotherapy within 3 weeks or radiotherapy within 2 weeks
  • Patients who are receiving any other investigational agents

Get in touch with our study team