What is the mechanism of action of this treatment?

Chemotherapy for breast cancer involves using drugs that target and kill rapidly dividing cancer cells. These drugs interfere with the cancer cells' ability to grow and divide, which can help control the spread of the disease and relieve symptoms. This is particularly important for breast cancer patients as it can improve survival rates and quality of life. Understanding these mechanisms allows for personalized treatment plans and better management of side effects, ultimately leading to more effective and tolerable cancer care.

What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly chemotherapy, often result in a range of side effects. These include nausea, vomiting, fatigue, and alopecia (hair loss). Neuropathy, characterized by numbness and tingling in the extremities, is also prevalent, especially with drugs like paclitaxel and oxaliplatin. Other side effects can include hand-foot syndrome, diarrhea, and increased risk of infections due to neutropenia. Cardiotoxicity is a serious concern with certain drugs like trastuzumab. Additionally, cognitive impairments and mental health issues such as depression and anxiety may occur.

What prior FDA approvals exist?

The FDA has approved several chemotherapy drugs for the treatment of breast cancer, particularly for advanced or metastatic stages. Commonly used agents include doxorubicin, paclitaxel, and carboplatin. These drugs work by killing or slowing the growth of cancer cells and are often used in combination to enhance efficacy. Doxorubicin, an anthracycline antibiotic, and paclitaxel, a taxane, are frequently used in various chemotherapy regimens. Carboplatin, a platinum-based drug, is also used, especially in cases where patients have shown resistance to other treatments. These agents have been integral in the management of breast cancer, providing options for patients who have progressed on prior therapies.

What other types of research exist?

Promising novel alternatives to chemotherapy for breast cancer patients in 2024 include targeted therapies such as PARP inhibitors for patients with BRCA mutations, and CDK4/6 inhibitors for hormone receptor-positive breast cancer. Immunotherapy, particularly immune checkpoint inhibitors like anti-PD-1 or anti-PD-L1 antibodies, is also emerging as a viable option. Additionally, investigational agents and personalized medicine approaches based on genetic profiling of tumors are showing potential in clinical trials.

← Back to Search

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

Must not have

Patients with active or uncontrolled infections or with serious illnesses or medical conditions which would not permit the patient to be managed according to the protocol

Patients who have received growth factors within 28 days prior to initiation of dosing of CFI-400945 or who will require treatment with growth factors throughout the duration of the trial

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

No Placebo-Only Group

Summary

This trial is testing a new drug called CFI-400945 for breast cancer patients who have already had chemotherapy. The drug works by blocking a protein that helps cancer cells grow, potentially slowing down or killing the cancer cells.

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.

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.

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 below

Select...

I have given permission for my tissue sample to be used for research.

Select...

My breast cancer is advanced, cannot be surgically removed, or has come back.

Select...

I am a female patient.

Select...

I am fully active or restricted in physically strenuous activity but can do light work.

Select...

I can take pills and don't have stomach issues affecting medicine absorption.

Select...

I've had chemotherapy for breast cancer that included anthracycline and taxane.

Select...

My disease is confirmed by clinical exams or imaging.

Select...

I am 18 years old or older.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

Select...

I do not have any serious illnesses or infections that would prevent me from following the study's requirements.

Select...

I have not used growth factors in the last 28 days and won't need them during the trial.

Select...

I am currently on a full dose of warfarin.

Select...

I do not have conditions that would make taking pills difficult, like severe bowel issues or constant vomiting.

Select...

I do not have serious heart, lung, brain diseases or infections.

Select...

I have HER2 positive breast cancer.

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.

Secondary study objectives

Biopsy

Molecular analyses of CFI-400945 on tumour cells through paired tumour biopsies using next generation DNA sequencing

Awards & Highlights

No Placebo-Only Group

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

Trial 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

0 / 14Eligibility criteria met

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

Chemotherapy for breast cancer involves using drugs that target and kill rapidly dividing cancer cells. These drugs interfere with the cancer cells' ability to grow and divide, which can help control the spread of the disease and relieve symptoms. This is particularly important for breast cancer patients as it can improve survival rates and quality of life. Understanding these mechanisms allows for personalized treatment plans and better management of side effects, ultimately leading to more effective and tolerable cancer care.

Receptor tyrosine kinase inhibitors for the treatment of osteosarcoma and Ewing sarcoma.Clinical and histopathological features of carcinosarcoma of the renal pelvis: a systematic review of a rare tumor.Promising novel therapies for the treatment of endometrial cancer.