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Protocol No. UW17098

Principal Investigator ORegan, Ruth

Phase I

Age Group Adult

Scope National

Sponsor Type Industry

Title Phase 1 Study of TTC-352 in Patients with Metastatic Breast Cancer Progressing on Endocrine Therapy

Objective The purpose of this research study is to find the highest and safest dose (maximum tolerated dose or MTD) of TTC-352, an experimental drug, in patients with metastatic, estrogen receptor positive breast cancer that has continued to progress (worsen) despite treatment with standard hormonal therapy. We are doing this research because TTC-352 is a new medication that has not been approved for the use described in this study by the Food and Drug Administration (FDA). This is the first time that this investigational drug will be used in human research. The study is designed to evaluate the safety and effectiveness of TTC-352 when given to patients with metastatic, estrogen receptor positive breast cancer that has progressed (continued to worsen) despite treatment with standard hormonal therapy.

Treatment Each treatment cycle is 28 days in length. You will take TTC-352 on Days 1 through 28 of each treatment cycle. Treatment may continue with additional 28-day cycles of treatment for as long as it is felt to be of benefit and you are experiencing no unacceptable side effect

Description A Phase 1 study of TTC-352 for patients with Metastatic Breast Cancer progressing on Endocrine Therapy

Key Eligibility
  • Must be greater than or equal to 18 years of age
  • Must have a diagnosis of metastatic, histologically confirmed ER+ breast cancer in patients who received and progressed on at least two lines of endocrine therapy, with one that included a CDK4/CDK6 inhibitor (e.g., palbociclib or ribociclib), and for which no effective standard therapy other than chemotherapy that confers clinical benefit is available
  • Must have metastatic disease evaluable on imaging studies
  • ECOG PS of 0-1
  • Must have adequate hematologic, renal and hepatic function
  • Can not be pregnant, or breast feeding and must agree to use adequate birth control
  • No prior chemotherapy, hormonal therapy, biologic therapy, immunotherapy or radiation therapy within 14 days prior to day 1
  • No prior history of venous thromboembolism, including deep vein thrombosis, pulmonary embolism or retinal vein thrombosis, unless currently on anticoagulant therapy
  • No uncontrolled or symptomatic CNS metastases
  • No severe, uncontrolled medical condition, including unstable congestive heart failure

  • Applicable Disease Sites Breast

    Status Open

    Participating Institutions UW Hospital and Clinics