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Brief Title: Phase 1b/2 Study of TTI-101 in Combination for Patients With Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
Official Title: REVERT- Breast Cancer: Phase 1b/2 Study of the Addition of STAT3 Inhibitor TTI-101 to Reverse Resistance to Palbociclib or Ribociclib Plus Aromatase Inhibitor or Fulvestrant Therapy for Metastatic Hormone Receptor-Positive and HER2-Negative Breast Cancer
Study ID: NCT05384119
Brief Summary: The primary objective of Phase 1b will be to evaluate the safety and tolerability of TTI-101 when added to palbociclib and AI or fulvestrant administered orally to participants with hormone receptor-positive (HR+) human epidermal receptor 2-negative (HER2)- palbociclib-resistant breast cancer, and to determine the recommended Phase 2 dose (RP2D) for TTI-101 when added to palbociclib and AI or fulvestrant. The primary objective of Phase 2 will be to evaluate anti-tumor activity in participants who receive TTI-101 added to palbociclib or ribociclib and AI or fulvestrant.
Detailed Description:
Minimum Age: 18 Years
Eligible Ages: ADULT, OLDER_ADULT
Sex: ALL
Healthy Volunteers: No
Holy Cross Health Fort Lauderdale - Holy Cross Hospital, Fort Lauderdale, Florida, United States
Washington University School of Medicine Siteman Cancer Center, Saint Louis, Missouri, United States
Vanderbilt - Ingram Cancer Center, Nashville, Tennessee, United States
Texas Oncology - Dallas Fort Worth (DFW) - Baylor Charles A. Sammons Cancer Center, Dallas, Texas, United States
Harold C. Simmons Comprehensive Cancer Center, Dallas, Texas, United States
University of Texas MD Anderson Cancer Center, Houston, Texas, United States