CFI-402257 + Paclitaxel 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, combined with the standard chemotherapy drug paclitaxel, to determine if it slows breast cancer growth more effectively than paclitaxel alone. The trial targets women with advanced or recurring breast cancer that cannot be surgically removed and for whom no cure exists. Ideal candidates have previously received treatment for breast cancer, require further systemic therapy, and can take oral medications. Participants should not have HER2-positive breast cancer or active infections. As a Phase 1/Phase 2 trial, this research aims to understand how the treatment works in people and measure its effectiveness in an initial, smaller group, offering participants the chance to contribute to early-stage cancer treatment advancements.
Do I need to stop my current medications to join the trial?
The trial protocol does not specify if you need to stop taking your current medications, but there is a requirement for a 'washout period' (time without taking certain medications) for some treatments. It's best to discuss your specific medications with the trial team to see if they are allowed.
Is there any evidence suggesting that this trial's treatments are likely to be safe?
Previous studies have shown that the combination of CFI-402257 and paclitaxel is generally safe for patients with HER2-negative breast cancer. Research indicates that most people tolerate this treatment well, with usually manageable side effects. Although some side effects were reported, they were not severe for most participants. This suggests that the treatment is relatively safe, though some risks remain. As with any new treatment, weighing both the potential benefits and side effects is important.12345
Why do researchers think this study treatment might be promising?
Researchers are excited about CFI-402257 combined with Paclitaxel for breast cancer because it introduces a novel approach by using an oral drug, CFI-402257, which targets specific cancer cell mechanisms. Unlike traditional treatments that mainly rely on chemotherapy, this combination promises a more targeted attack on cancer cells, potentially reducing side effects and improving effectiveness. Additionally, the intermittent dosing schedule of CFI-402257 might offer patients a more manageable treatment experience compared to continuous regimens.
What evidence suggests that CFI-402257 combined with paclitaxel could be an effective treatment for breast cancer?
Research shows that CFI-402257, a new drug for breast cancer, can slow tumor growth in lab tests. In this trial, participants will receive a combination of CFI-402257 and the common chemotherapy drug paclitaxel. Early studies indicate that 11-14% of patients with advanced HER2-negative breast cancer responded to this combination treatment, suggesting it might work for some individuals. The combination is also considered safe for most patients, as it doesn't cause severe side effects. Overall, while early data remains limited, there is hope that this treatment could offer more benefits than using paclitaxel alone.12456
Who Is on the Research Team?
Philippe Bedard
Principal Investigator
Princess Margaret Cancer Centre, Toronto, ON
Mihaela Mates
Principal Investigator
Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, ON
Are You a Good Fit for This Trial?
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.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Phase I Treatment
Participants receive CFI-402257 with paclitaxel to determine the maximum tolerated dose
Phase II Treatment
Participants receive CFI-402257 with paclitaxel at the determined safe dose to evaluate its effect on breast cancer
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- CFI-402257
- Paclitaxel
Paclitaxel is already approved in United States, European Union, Canada for the following indications:
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi's sarcoma
Find a Clinic Near You
Who Is Running the Clinical Trial?
Canadian Cancer Trials Group
Lead Sponsor
Stand Up To Cancer
Collaborator
Canadian Breast Cancer Foundation
Collaborator
Ontario Institute for Cancer Research
Collaborator