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CFI-402257 in Combination With Paclitaxel in Patients With Advanced/Metastatic HER2-Negative Breast Cancer

NCT03568422 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 37

Last updated 2026-03-27

Study results available
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Summary

The standard or usual treatment for this disease is to undergo chemotherapy to slow the spread of disease and relieve some symptoms of cancer. One of the standard types of chemotherapy is a drug called paclitaxel (Taxol) given in a low dose every week for three out of four weeks.

CFI-402257 is a new type of drug for breast cancer. Laboratory tests show that it may help slow the growth of breast cancer. This drug has been shown to shrink tumours in animals. CFI-402257 has been studied in a few people and appears well tolerated with little side effects. CFI-402257 seems promising but it is not clear if it can offer better results when given with paclitaxel compared to paclitaxel alone.

Conditions

Interventions

DRUG

CFI-402257

Orally taken on intermittent schedule (days 1, 2, 8, 9, 15 \& 16

DRUG

Paclitaxel

80 mg/m2 IV days 1, 8 \& 15 every 28 days

Sponsors & Collaborators

  • Stand Up To Cancer

    collaborator OTHER

  • Canadian Breast Cancer Foundation

    collaborator OTHER

  • Ontario Institute for Cancer Research

    collaborator OTHER

  • Canadian Cancer Trials Group

    lead NETWORK

Principal Investigators

  • Philippe Bedard · Princess Margaret Cancer Centre, Toronto, ON

  • Mihaela Mates · Cancer Centre of Southeastern Ontario at Kingston General Hospital, Kingston, ON

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2019-02-05
Primary Completion
2022-11-21
Completion
2026-12-31
FDA Drug
Yes

Countries

  • Canada

Study Locations

More Related Trials

Entities

Drugs
Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03568422 on ClinicalTrials.gov