What side effects are associated with this type of intervention?

Common treatments for breast cancer, such as immune system stimulation, immune system boosters, and chemotherapy, have various side effects. Immune system stimulation with vaccines can cause injection site reactions, fever, and fatigue. Immune system boosters like Sargramostim (GM-CSF) often result in bone pain, fever, and injection site reactions. Chemotherapy agents like Cyclophosphamide are associated with nausea, vomiting, hair loss, and increased infection risk due to bone marrow suppression. Combining these treatments may lead to overlapping side effects, requiring careful management by healthcare providers.

What prior FDA approvals exist?

The FDA has approved several treatments for breast cancer that align with the categories of immune system stimulation, immune system boosters, and chemotherapy. For immune system stimulation, pembrolizumab (Keytruda) is an FDA-approved immune checkpoint inhibitor used in certain cases of breast cancer. Sargramostim (GM-CSF) is an immune system booster that has been used to enhance the immune response in various cancer treatments, although its specific approval for breast cancer may be limited. Cyclophosphamide is a well-established chemotherapy agent that has been widely used in breast cancer treatment to kill cancer cells, inhibit their division, and prevent their spread. These treatments reflect the multi-faceted approach of combining immunotherapy and chemotherapy to enhance treatment efficacy.

What other types of research exist?

Promising novel alternatives for breast cancer treatment in 2024 include: 1) Pembrolizumab (an immune checkpoint inhibitor targeting PD-1) for its efficacy in triple-negative breast cancer, 2) Sacituzumab govitecan (an antibody-drug conjugate targeting Trop-2) for its effectiveness in metastatic triple-negative breast cancer, and 3) Alpelisib (a PI3K inhibitor) combined with fulvestrant for PIK3CA-mutated, hormone receptor-positive, HER2-negative advanced breast cancer.

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Chemotherapy

Cancer Vaccine + GM-CSF and Cyclophosphamide for Triple Negative Breast Cancer

Phase 2

Waitlist Available

Led By Kathryn J Ruddy

Research Sponsored by Academic and Community Cancer Research United

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Age >= 18 years

Female

Must not have

Nursing women

Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements

Timeline

Screening 3 weeks

Treatment Varies

Follow Up through study completion (average of 5 years)

Summary

This trial tests a combination of a special vaccine, an immune booster, and a chemotherapy drug to prevent the return of triple negative breast cancer. It aims to help the immune system fight off cancer cells and use chemotherapy to kill any remaining ones.

Who is the study for?

This trial is for women aged 18+ with stage 1-3 triple negative breast cancer who've completed surgery and other treatments within the past 90 to 546 days. They must have a good performance status, adequate organ function, and no evidence of metastatic disease or recurrence. Women must not be pregnant, nursing, immunocompromised on antiretroviral therapy, or have active autoimmune diseases.

What is being tested?

The study tests if a vaccine made from white blood cells and tumor proteins plus GM-CSF (sargramostim) and cyclophosphamide can prevent cancer recurrence in patients post-surgery. Participants are randomly assigned to receive either this combination treatment or a placebo in an effort to stimulate the immune system against cancer cells.

What are the potential side effects?

Potential side effects include reactions at the injection site from the vaccine, flu-like symptoms due to GM-CSF, and typical chemotherapy-related issues like nausea, hair loss, low blood cell counts leading to increased infection risk from cyclophosphamide.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I am 18 years old or older.

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I am female.

Exclusion Criteria

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

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I am currently breastfeeding.

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I do not have any severe illnesses or social situations that would stop me from following the study's requirements.

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I have used trastuzumab or other HER2-targeted treatments.

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I am a woman who can have children and do not plan to use birth control.

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I have not had or been treated for another cancer in the last 5 years.

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I am not currently receiving any experimental drugs or other cancer treatments.

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My cancer has returned or spread to other parts of my body.

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I am HIV positive and currently on antiretroviral therapy.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ through study completion (average of 5 years)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~through study completion (average of 5 years)

This trial's timeline: 3 weeks for screening, Varies for treatment, and through study completion (average of 5 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

Disease-free survival

Secondary study objectives

FRalpha levels

Incidence of adverse events assessed by Common Terminology Criteria for Adverse Events 4.0

Overall survival

+1 more

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Arm I (FRalpha peptide vaccine, sargramostim)Experimental Treatment4 Interventions

Patients receive cyclophosphamide PO BID on days 1-7 and 15-21 of cycle 1 only. Starting cycle 2, patients receive multi-epitope folate receptor alpha peptide vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.

Group II: Arm II (placebo, sargramostim)Placebo Group4 Interventions

Patients receive cyclophosphamide as in Arm I. Starting cycle 2, patients receive placebo vaccine with sargramostim ID on day 1. Treatment repeats every 28 days for cycles 2-7 and every 6 months for cycles 8-14 in the absence of disease progression or unacceptable toxicity.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Sargramostim

2006

Completed Phase 4

~880

Cyclophosphamide

2010

Completed Phase 4

~2310

Multi-epitope Folate Receptor Alpha Peptide Vaccine

2012

Completed Phase 1

~30

0 / 10Eligibility 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

Breast cancer treatments often involve a combination of therapies that target the cancer in different ways. Immune system stimulation, such as with the multi-epitope folate receptor alpha peptide vaccine, helps the body recognize and attack cancer cells by training the immune system to identify tumor-specific proteins. Immune system boosters like sargramostim (GM-CSF) enhance the body's immune response by increasing the production and activity of white blood cells. Chemotherapy agents such as cyclophosphamide work by killing rapidly dividing cancer cells, inhibiting their division, and preventing their spread. These mechanisms are crucial for breast cancer patients as they provide a multi-faceted approach to controlling and potentially eradicating the disease, improving survival rates and quality of life.