REVERT Breast Cancer Clinical Trial
Tvardi Clinical Trials
Phase 2 Clinical Trial:
TTI-101 in combination for Stage 4 Metastatic HR+ HER2- Breast Cancer
The REVERT Metastatic Breast Cancer Clinical Trial
The REVERT breast cancer study is a Phase 2 clinical trial of an investigational medication, TTI-101, an oral medication, for the treatment in combination with palbociclib and an Aromatase Inhibitor (AI: anastrozole, letrozole, and exemestane) for metastatic Hormone Receptor Positive (HR+) Human Epidermal growth factor Receptor 2 Negative (HER2-) breast cancer in those patients who have met criteria for progression on current treatment.
Breast Cancer Prevalence
Breast cancer is the most common cancer in women. The most common subtype of breast cancer defined by receptor status is hormone receptor positive (HR+) and human epidermal growth factor receptor 2 negative (HER2-).
What is HR+ HER2- Metastatic Breast Cancer?
HR+ HER2- metastatic breast cancer is breast cancer that has all three qualities:
Metastatic breast cancer is breast cancer that has spread beyond the breast into other organs or lymph nodes.
HR+ stands for hormone receptor positive and can refer to breast cancer cells that have either estrogen (ER) or progesterone (PR) receptors, or both estrogen and progesterone receptors.
HER2- stands for human epidermal growth factor receptor 2 negative and describes breast cancer cells that have either a small amount or none of the protein HER2 on their surface.
Who May be Eligible to Participate in the Clinical Trial
If you are an adult with metastatic HR+ HER2- breast cancer, showing signs of progressive disease while taking both palbociclib and AIs, you may be eligible to participate in our clinical trial. Please contact your preferred clinical trial location.
What Can You Expect if You Participate in the Clinical Trial
Your participation in this clinical trial will include 3 periods: Screening, Clinical Trial Treatment, and Follow-up. During the screening period, your doctor will perform tests to find out if you are eligible to take the clinical trial treatment given during the REVERT clinical trial. If you are eligible and take part in the first phase of the clinical trial, you will be assigned to receive 1 of 3 dosages of TTI-101 to determine the recommended dose of the clinical trial drug. In the second phase of the clinical trial, you will receive the recommended dose of TTI-101 from the first phase of the clinical trial in combination with palbociclib and aromatase inhibitor.
You will continue on treatment unless your cancer progresses, you leave the clinical trial, or the clinical trial ends. Four weeks after the last dose, you will be asked to return for a follow-up visit, and then clinical trial staff will check in with you every 8 weeks until the clinical trial ends.
TTI-101 is an oral STAT3 inhibitor that reduces STAT3 activity. STAT3 is a key protein known to regulate many biological functions that when overactive can promote tumor growth and metastasis, both of which often contribute to the development and progression of breast cancer. TTI-101 has completed enrollment for its Phase 1 trial of patients with advanced solid tumors who have failed all lines of therapy. To date, TTI-101 taken alone has been well-tolerated.
TTI-101 is an investigational drug, meaning it is not currently approved by the US Food and Drug Administration (FDA). While palbociclib and AIs used in this clinical trial are FDA-approved drugs, their use in combination with TTI-101 is also considered investigational.
Interested in Participating at One of Our Active Sites?
Find out more today about our new clinical trial treatment for breast cancer and learn more about Tvardi’s participating clinical trial locations across the United States. Please visit the clinicaltrials.gov website for up to date clinical trial information ongoing at multiple U.S. locations. Click below for an updated list of participating clinical trial locations.
About Tvardi Therapeutics
The REVERT breast cancer clinical trial is sponsored by Tvardi Therapeutics, a privately held, clinical-stage biopharmaceutical company developing small molecule inhibitors of STAT3. TTI-101 as a STAT3 inhibitor reduces STAT3 activity. STAT3 is a key protein known to be involved in many biological functions that when overactive can promote tumor growth and metastasis.