Your session is about to expire
← Back to Search
Other
CFI-402257 + Paclitaxel for Breast Cancer
Phase 1 & 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
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
Study Summary
This trial is testing whether CFI-402257 is better than the standard chemotherapy (paclitaxel) when given together.
Who is the study for?
This trial is for adult women with advanced or metastatic HER2-negative breast cancer who have not responded well to non-taxane chemotherapy. They must be in good physical condition (ECOG 0 or 1), able to swallow pills, and willing to use effective contraception. Exclusions include previous taxane treatment in the metastatic setting, certain heart conditions, uncontrolled illnesses, known drug hypersensitivity, and recent major surgery.Check my eligibility
What is being tested?
The study tests CFI-402257 combined with paclitaxel against breast cancer. CFI-402257 is a new drug that has shown promise in early studies and animal models by potentially slowing tumor growth. The trial will compare its effectiveness when added to the standard chemotherapy drug paclitaxel.See study design
What are the potential side effects?
Possible side effects of CFI-402257 are not fully known but appear minimal so far; however, it's common for patients on paclitaxel to experience hair loss, nerve damage (neuropathy), fatigue, and increased risk of infection due to low blood cell counts.
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
Phase I: Identify the recommended phase II dose
Phase I: Safety and tolerability of CFI-402257 assessed by CTCAE
Phase II: Overall Response Rate using RECIST 1.1
Secondary outcome measures
Clinical benefit rate determined by complete response, partial response or stable disease
Number and severity of adverse events by CTCAE
Side effects data
From 2014 Phase 4 trial • 32 Patients • NCT0130172959%
Leukopenia
56%
Neutropenia
34%
Hypoaesthesia
31%
Agranulocytosis
22%
Alopecia
22%
Asthenia
19%
Pyrexia
16%
Nail disorder
16%
Oedema peripheral
16%
Diarrhoea
16%
Hypophagia
13%
Neurotoxicity
13%
Alanine aminotransferase increased
13%
Cough
13%
Vomting
9%
Headache
9%
Musculoskeletal pain
9%
Aspartate aminotransferase increased
9%
Chest discomfort
9%
Rash
9%
Pigmentation disorder
9%
Nausea
9%
Bone marrow failure
9%
Anaemia
6%
Transaminases increased
6%
Insomnia
6%
Constipation
6%
Mouth ulceration
6%
Nasopharyngitis
6%
Paronychia
6%
Flushing
6%
Face oedema
6%
Thrombocytopenia
3%
Infection
3%
Upper respiratory tract infection
3%
Completed suicide
3%
Cataract
100%
80%
60%
40%
20%
0%
Study treatment Arm
Trastuzumab
Trial Design
1Treatment groups
Experimental Treatment
Group I: CFI-402257 + PaclitaxelExperimental Treatment2 Interventions
Oral CFI-402257 on intermittent schedule:* days 1, 2, 8, 9, 15 & 16 q4w Plus Paclitaxel 80 mg/m2 IV days 1, 8 & 15 every 28 days
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Paclitaxel
2011
Completed Phase 4
~5380
Find a Location
Who is running the clinical trial?
Stand Up To CancerOTHER
51 Previous Clinical Trials
40,257 Total Patients Enrolled
3 Trials studying Breast Cancer
109 Patients Enrolled for Breast Cancer
Canadian Cancer Trials GroupLead Sponsor
124 Previous Clinical Trials
67,416 Total Patients Enrolled
8 Trials studying Breast Cancer
8,687 Patients Enrolled for Breast Cancer
Canadian Breast Cancer FoundationOTHER
25 Previous Clinical Trials
8,246 Total Patients Enrolled
14 Trials studying Breast Cancer
6,716 Patients Enrolled for Breast Cancer
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- You have a documented disease that has been confirmed by clinical or radiological tests. The tests must have been done within the last 21 days (or 28 days if the results were negative). For phase Ib, you don't need to have specific measurements, but for phase II, your disease needs to meet specific size criteria on different tests.You have breast cancer that is positive for the HER2 protein.You have already received other treatments like hormone therapy, immunotherapy, or targeted therapies.You have enough white blood cells called neutrophils in your body.Your platelet count is at least 100 billion per liter.Your bilirubin level needs to be within a certain range.Your kidneys are working well and your blood creatinine levels are within a certain range.You have had heart problems that have not been treated or are not under control. Even if your heart condition is managed, your heart's pumping ability should be at least 50%.You should not have been treated with certain hormone therapy or taxanes for cancer that has spread.You are taking a high dose of warfarin, or you have a history of blood clots and are taking certain blood thinners.You have had another type of cancer that was not treated or required treatment within the past 2 years.You cannot have paclitaxel treatment or have severe nerve damage.You have had cancer spread to your brain or spinal cord, unless it has been treated and you are stable without needing corticosteroids.You need to have a tissue sample from your tumor available for the study. It's also recommended that you get a biopsy if it's safe and possible. If you agree, the biopsies will be done before and after treatment. The biopsies may not only be taken from the main tumor.You must have tried a different kind of chemotherapy before, unless you relapsed within 6 months of finishing a certain type of chemotherapy, or you received a different type of chemotherapy at least 6 months before your relapse, or you cannot have a certain type of palliative chemotherapy other than weekly paclitaxel.Your liver function tests (AST and ALT) should be within a certain range, and if you have cancer spread to the liver, there is a slightly different range for these tests.
Research Study Groups:
This trial has the following groups:- Group 1: CFI-402257 + Paclitaxel
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.
How many participants have been recruited for this research endeavor?
"This investigation is no longer recruiting participants. It was initially posted on October 17th 2018 and last edited 7 months ago, in October 2022. For those seeking other trials, there are presently 2,596 studies enrolling patients with breast cancer and 832 for CFI-402257 actively looking for volunteers."
Answered by AI
Has CFI-402257 been the subject of any prior investigations?
"At the moment, 832 research studies are underway for CFI-402577 with 227 of them at Phase 3. 45639 sites globally have trials related to this drug, including Woolloongabba in Queensland."
Answered by AI
How many venues are currently hosting this clinical experiment?
"Currently, this clinical trial is recruiting participants from 4 sites across Canada located in Ottawa, Kingston and Vancouver as well as other nearby areas. To reduce travel requirements should you choose to join the study, it would be prudent to select a participating clinic closest to your location."
Answered by AI
Are there any slots remaining in this experiment for participants?
"According to the details hosted on clinicaltrials.gov, this medical study is not accepting applicants at present. Initially posted in October 2018 and last edited in October 2022, it has stopped recruiting patients; however there are an abundance of alternative trials still looking for volunteers."
Answered by AI
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger