What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as paclitaxel, trastuzumab, and tamoxifen, have well-documented side effects. Paclitaxel is associated with peripheral neuropathy, neutropenia, and fatigue. Trastuzumab can cause cardiac dysfunction and infusion-related reactions. Tamoxifen's side effects include hot flashes, increased risk of thromboembolic events, and endometrial cancer. These treatments aim to slow cancer progression but come with significant adverse effects that need to be managed carefully.

What prior FDA approvals exist?

The FDA has approved several drugs for the treatment of breast cancer that aim to slow its growth. Notable examples include paclitaxel (Taxol), a chemotherapy drug that disrupts cell division, and trastuzumab (Herceptin), a monoclonal antibody targeting the HER2 receptor. Additionally, CDK 4/6 inhibitors like palbociclib (Ibrance) and ribociclib (Kisqali) have been approved for their ability to inhibit proteins essential for cell cycle progression. These treatments, like CFI-402257, aim to control cancer growth through various mechanisms.

What other types of research exist?

Promising novel alternatives to CFI-402257 for breast cancer treatment in 2024 include: 1) Sacituzumab govitecan, an antibody-drug conjugate targeting Trop-2, which has shown efficacy in metastatic triple-negative breast cancer. 2) Alpelisib, a PI3K inhibitor used in combination with fulvestrant for HR-positive, HER2-negative advanced breast cancer with PIK3CA mutations. 3) Pembrolizumab, an immune checkpoint inhibitor targeting PD-1, used in combination with chemotherapy for triple-negative breast cancer. 4) Trastuzumab deruxtecan, another antibody-drug conjugate, for HER2-positive breast cancer. These therapies have demonstrated significant clinical benefits and are considered promising options for breast cancer patients.

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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

No Placebo-Only Group

Summary

This trial tests a new drug, CFI-402257, combined with an existing chemotherapy drug, paclitaxel, in breast cancer patients. It aims to find the highest safe dose of CFI-402257 and evaluate if this combination works better than using paclitaxel by itself.

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.

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.

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

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Phase I: Recommended Phase II Dose for CFI-402257

Phase II: Overall Response Rate Using RECIST 1.1

Secondary study objectives

Phase II: Clinical Benefit Rate Determined by Complete Response, Partial Response or Stable Disease

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

~5450

Do I qualify?Apply below to find out

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer include chemotherapy, targeted therapy, and hormonal therapy. Chemotherapy, such as paclitaxel, works by disrupting cell division, leading to cancer cell death. Targeted therapies, like trastuzumab, specifically attack cancer cells with certain markers (e.g., HER2) without affecting normal cells. Hormonal therapies, such as tamoxifen, block hormones like estrogen that fuel certain breast cancers. Understanding these mechanisms helps patients and doctors choose the most effective treatment based on the cancer's characteristics. The trial drug CFI-402257 is being studied for its potential to slow breast cancer growth, possibly offering a new targeted approach when combined with paclitaxel.

Endocrine and targeted manipulation of breast cancer: summary statement for the Sixth Cambridge Conference.