Active — Not RecruitingPhase 1

Alpelisib And Sacituzumab Govitecan For Treatment Of Breast Cancer

United States18 participantsStarted 2022-03-28

Plain-language summary

This study evaluates the safety and efficacy of sacituzumab govitecan plus alpelisib for treatment of metastatic or locally recurrent HER2-negative breast cancer.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Ability of participant OR Legally Authorized Representative (LAR) to understand this study, and participant or LAR willingness to sign a written informed consent
✓. Males and females age ≥ 18 years
✓. ECOG Performance Status 0 - 2 (See Appendix A)
✓. Histologically proven HER2-negative breast cancer (per current ASCO-CAP guidelines); HER2-negative breast cancer includes hormone receptor-positive (estrogen receptor and/or progesterone receptor-positive) breast cancer and TNBC.
✓. HER2-negative breast cancer that at the time of study entry is either stage III (locally advanced) disease not amenable to curative therapy, or stage IV disease. Histological confirmation of recurrent/metastatic disease is encouraged but not required if clinical evidence of stage IV disease is available.
✓. Have measurable or evaluable disease.
✓. Ability to swallow and retain oral medicines.
✓. No limitations to number of prior chemotherapies or endocrine therapies for metastatic disease.

Exclusion criteria

✕. Simultaneously enrolled in any therapeutic clinical trial
✕. Current or anticipating use of other anti-neoplastic or investigational agents while participating in this study
✕. Diagnosed with a psychiatric illness or is in a social situation that would limit compliance with study requirements
✕. Is pregnant or breastfeeding
✕. Has a known allergic reaction to any excipient contained in the study drug formulation Active Grade 3 (per the NCI CTCAE, Version 5.0) or higher viral, bacterial, or fungal infection within 2 weeks prior to the first dose of study treatment.
✕. Patient has previously been treated with sacituzumab govitecan or alpelisib.
✕. Patient has a concurrent malignancy or malignancy within 3 years of study enrollment (with the exception of adequately treated basal or squamous cell carcinoma, non-melanomatous skin cancer, or curatively resected cervical cancer).
✕. Diabetes mellitus type I, or uncontrolled type II based on fasting plasma glucose and HbA1c meeting either of the following:

What they're measuring

Recommended phase II dose (RP2D) of alpelisib + sacituzumab govitecan

Timeframe: 21 days

Trial details

NCT IDNCT05143229

SponsorUniversity of Kansas Medical Center

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2025-01-28

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