CFI-402257 + Fulvestrant for Breast Cancer
What You Need to Know Before You Apply
What is the purpose of this trial?
This trial tests a new drug, CFI-402257, alone and with Fulvestrant in patients with advanced solid tumors and advanced breast cancer. It aims to determine if the drug is safe and effective by studying its effects on the body and cancer cells. Fulvestrant is an established treatment for hormone receptor-positive advanced breast cancer, often used in combination with other therapies to improve outcomes.
Will I have to stop taking my current medications?
The trial requires that you avoid using certain medications, specifically strong CYP3A4 inducers and inhibitors, and some other specific drugs. If you are taking these, you may need to stop or adjust them before joining the trial.
Is the combination of CFI-402257 and Fulvestrant safe for humans?
What makes the drug CFI-402257 + Fulvestrant unique for breast cancer treatment?
CFI-402257 combined with Fulvestrant is unique because Fulvestrant is a selective estrogen receptor down-regulator (SERD) that targets and degrades estrogen receptors without any agonist effects, offering a new option for women with advanced breast cancer who have become resistant to other treatments like tamoxifen.12367
What data supports the effectiveness of the drug CFI-402257 + Fulvestrant for breast cancer?
Who Is on the Research Team?
R Wesolowski
Principal Investigator
The Ohio State University Comprehensive Cancer Center
Are You a Good Fit for This Trial?
This trial is for adults with advanced solid tumors or breast cancer that's positive for estrogen/progesterone receptors but negative for HER2. They must have tried certain therapies before, like a CDK4/6 inhibitor and possibly one line of endocrine therapy or chemotherapy. People can't join if they have brain cancer, serious heart conditions, are pregnant/nursing, had recent treatments/surgery, infections, blood clots or coagulopathy.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Monotherapy Escalation and Expansion
Dose selection and expansion of CFI-402257 as a single agent in advanced solid tumors
Combination Escalation and Expansion
Dose selection and expansion of CFI-402257 in combination with Fulvestrant in advanced breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CFI-402257
- Fulvestrant
Find a Clinic Near You
Who Is Running the Clinical Trial?
Treadwell Therapeutics, Inc
Lead Sponsor