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Protein Kinase Inhibitor
Immunotherapy with CFI-400945 for Breast Cancer
Phase 2
Waitlist Available
Research Sponsored by Canadian Cancer Trials Group
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Patients must have a formalin fixed paraffin embedded tissue block available and must have provided informed consent for the release of the block
Patients must have histologically and/or cytologically confirmed diagnosis of breast cancer, that is advanced/metastatic/recurrent or unresectable
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing a new immunotherapy drug to see if it can help patients with this disease.
Who is the study for?
This trial is for female patients over 18 with advanced/metastatic breast cancer who've had chemotherapy including anthracycline and taxane. They must be able to swallow pills, have no serious illnesses that could interfere with the study, and not be pregnant or breastfeeding. Participants need a life expectancy of at least 3 months, adequate organ function, and must agree to use contraception.Check my eligibility
What is being tested?
The trial tests CFI-400945 in women who have already undergone chemotherapy for breast cancer. It aims to see if this oral medication can further slow disease progression compared to standard treatments. Patients will use a Pillsy system for monitoring pill intake.See study design
What are the potential side effects?
Potential side effects of CFI-400945 are not specified here but may include typical reactions similar to other chemotherapy drugs such as nausea, fatigue, blood disorders, liver issues, and increased risk of infection.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have given permission for my tissue sample to be used for research.
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My breast cancer is advanced, cannot be surgically removed, or has come back.
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I am a female patient.
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I am fully active or restricted in physically strenuous activity but can do light work.
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I can take pills and don't have stomach issues affecting medicine absorption.
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I've had chemotherapy for breast cancer that included anthracycline and taxane.
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My disease is confirmed by clinical exams or imaging.
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I am 18 years old or older.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Objective Response defined by RECIST 1.1
Secondary outcome measures
Disease Control Rate (DCR) defined by RECIST 1.1
Biopsy
Molecular analyses of CFI-400945 on tumour cells through paired tumour biopsies using next generation DNA sequencing
+1 moreTrial Design
3Treatment groups
Experimental Treatment
Group I: Cohort 3: Not PTEN-null, ER+ and/or PR+, HER2-Experimental Treatment1 Intervention
N=9 to 24 patients
Group II: Cohort 2: PTEN-null, ER+ and/or PR+, HER2-Experimental Treatment1 Intervention
N=9 to 24 patients
Group III: Cohort 1: TNBCExperimental Treatment1 Intervention
N=9 to 24 patients
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
CFI-400945
2014
Completed Phase 1
~50
Find a Location
Who is running the clinical trial?
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,402 Total Patients Enrolled
8 Trials studying Breast Cancer
8,673 Patients Enrolled for Breast Cancer
Stand Up To Cancer Canada-Canadian Cancer Society Breast Cancer Dream TeamUNKNOWN
David CesconStudy ChairPrincess Margaret Cancer Centre, Toronto, ON
2 Previous Clinical Trials
499 Total Patients Enrolled
2 Trials studying Breast Cancer
499 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I do not have any serious illnesses or infections that would prevent me from following the study's requirements.I have given permission for my tissue sample to be used for research.I have had cancer before, but it was either skin cancer treated fully, cervical cancer treated without spreading, or any cancer treated over 2 years ago with no current signs of disease.I have not used growth factors in the last 28 days and won't need them during the trial.I am currently on a full dose of warfarin.Your blood counts, liver function, and kidney function need to be within certain levels for you to participate in the study.I had brain or spinal cancer but am stable now and don't need steroids.I do not have conditions that would make taking pills difficult, like severe bowel issues or constant vomiting.My breast cancer is advanced, cannot be surgically removed, or has come back.I am a female patient.I am fully active or restricted in physically strenuous activity but can do light work.I can take pills and don't have stomach issues affecting medicine absorption.I've had chemotherapy for breast cancer that included anthracycline and taxane.I have received treatments like hormone therapy, immunotherapy, or targeted therapy.I had external beam radiation at least 28 days ago.I have recovered from side effects of my previous cancer treatments.It has been over 21 days since my last surgery.My disease is confirmed by clinical exams or imaging.I do not have serious heart, lung, brain diseases or infections.I have HER2 positive breast cancer.I am 18 years old or older.
Research Study Groups:
This trial has the following groups:- Group 1: Cohort 3: Not PTEN-null, ER+ and/or PR+, HER2-
- Group 2: Cohort 1: TNBC
- Group 3: Cohort 2: PTEN-null, ER+ and/or PR+, HER2-
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- 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
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Has CFI-400945 been proven to be a reliable therapeutic option for patients?
"Although there is some evidence supporting CFI-400945's safety, the absence of clinical data on efficacy prevents it from receiving a score higher than 2."
Answered by AI
What is the capacity of participants in this medical research?
"Correct. The data hosted on clinicaltrials.gov verifies that this medical trial, which was first posted on December 21st 2018, is currently recruiting participants. A total of 72 patients need to be enrolled from 6 distinct sites."
Answered by AI
Are there any opportunities for new participants to join this research endeavor?
"Affirmative. Clinicaltrials.gov displays that this clinical trial, initially posted on December 21st 2018, is currently selecting participants for the study. 72 patients across 6 distinct medical centres need to be enrolled in the research project."
Answered by AI
Are there any Canadian medical centers running this trial presently?
"In order to participate, patients can visit one of the 6 trial sites located in Ontario. These include: Ottawa Hospital Research Institute in Ottawa, London Regional Cancer Program in London, and University Health Network in Toronto--other clinical locations exist as well."
Answered by AI
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