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Study of Two Drugs in ER+ and/or PR+ Cancers With PI3K and/or PTEN Tumor or Inherited Mutations

Clinicaltrials.gov identifier:
NCT05082025

Treatment
People with advanced breast or endometrial or ovarian cancer

Study Contact Information:

For additional information, please contact:

Timothy Yap, MD  by phone at (713) 563-1784 or email at [email protected]

Study of Two Drugs in ER+ and/or PR+ Cancers With PI3K and/or PTEN Tumor or Inherited Mutations

About the Study

This study is investigating if the study drug copanlisib, when used in combination with fulvestrant, is safe and effective for people with certain advanced ER-positive and/or PR-positive cancers.  People with PI3K and/or changes in tumor tissue or inherited mutations are eligible.

What the Study Involves

All study participants will receive the study drug, copanlisib injected into the vein (intravenously) in combination with fulvestrant injected in the muscle (intramuscularly) over 28-day cycles.

Study participants will be followed an average of 1 year.  

Study Site

Texas
MD Anderson Cancer Center
Houston, Texas
Contact: Timothy Yap, MD 713-563-1784 [email protected]  
Principal Investigator: Timothy Yap, MD

This Study is Open To:

Individuals aged 18 years or older who meet the following criteria:

  • ER+ and/or PR+ advanced or ovarian cancer, endometrial cancer, or breast cancer.
  • Cancer indicates PI3K and/or mutations in tumor tissue. Patient may also have inherited mutations in PIK3CA, PIK3R1, and genes.
  • Patients have no available standard therapy option known to prolong survival.
This Study is Not Open To:
  • Ovarian cancer or endometrial cancer patients who received prior treatment with fulvestrant or any PI3Ki.
  • Taking warfarin or other drug to prevent blood clots
  • Human immunodeficiency virus (HIV) infection.
  • Significant uncontrolled heart disease and/or recent cardiac events
  • Type 1 diabetes or uncontrolled type 2 diabetes.
  • Active hepatitis B or hepatitis C requiring treatment.
  • Central nervous system (CNS) involvement. Contact the study team for information about specific CNS exception criteria.