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CFI-402257 + Fulvestrant for Breast Cancer
Study Summary
This trial is testing an investigational drug to see if it is safe to use alone or with another drug to treat people with advanced solid tumors or advanced breast cancer.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowTimeline
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Side effects data
From 2016 Phase 2 & 3 trial • 12 Patients • NCT02116803Trial Design
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Who is running the clinical trial?
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- I do not have severe uncontrolled high blood pressure, heart failure symptoms, chest pain, recent heart attack, constant irregular heartbeat, or a long QT interval.I have been treated with a TTK/MPS1 inhibitor before.I had radiotherapy less than 2 weeks ago.I haven't had chemotherapy or other cancer treatments in the last 4 weeks.I have previously been treated with fulvestrant or similar drugs.I have not had blood clotting issues or a history of them in the last 6 months.I have another active cancer besides my primary one.I have not had major surgery in the last 3 weeks.You have breast cancer that is positive for estrogen receptor and/or progesterone receptor, but negative for HER2. You have previously taken a CDK4/6 inhibitor and have received no more than one round of chemotherapy. You have measurable disease based on specific guidelines.I have not used growth factors within 14 days before starting CFI-402257 treatment.I currently have a serious infection.I do not have a bleeding disorder that prevents me from taking fulvestrant.I have a brain tumor or cancer that has spread to my brain.I am currently on a full dose of warfarin.My advanced cancer has worsened despite previous treatment.I have another active cancer besides ER+/HER2- advanced breast cancer.I have ER+/PR+ HER2- breast cancer, treated with CDK4/6 inhibitors, and limited prior therapy.I am not taking any strong medications that affect liver enzymes.
- Group 1: Part A: Monotherapy Escalation and Expansion
- Group 2: Part B: Combination Escalation and Expansion
- All Individual Drugs Already Approved - Therapies where all constituent drugs have already been approved are likely to have better-understood side effect profiles.
- Approved for 10 Other Conditions - This treatment demonstrated efficacy for 10 other conditions.
- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
What aim is this inquiry seeking to achieve?
"According to the data provided by Treadwell Therapeutics, Inc., this 48-month assessment has a primary goal of quantifying adverse events associated with CFI-402257 as well as secondary objectives including measuring changes in variant allele function via circulating tumor deoxyribonucleic acid level comparison to baseline concentrations, evaluating the pharmacokinetic profile of CFI-402257 and fulvestrant when combined through area under concentration curves from time 0 to least measurable concentration tabulated per dose group ,and assessing objective response rates categorized within each tumour cohort."
How many participants is the trial currently accommodating?
"This clinical trial requires 44 participants who meet the pre-defined eligibility criteria. Interested candidates may sign up at START - Mountain Region in West Valley City, Utah or The Ohio State University Comprehensive Cancer Centre in Columbus, Ohio."
Is there currently an open enrolment period for this clinical trial?
"Indeed, the clinicaltrials.gov portal indicates that this research trial is actively seeking participants. Initial postings were made on May 27th 2022 and subsequently edited on July 26th of the same year. The study requires 44 volunteers across 3 separate sites."
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