Study on Vaccine, GM-CSF, and Cyclophosphamide for Preventing Recurrence in Triple Negative Breast Cancer
Sponsor: Academic and Community Cancer Research United
ClinicalTrials ID:NCT03012100
This clinical trial is testing a new combination of treatments, including a vaccine, to see if they can help prevent the return of stage 1-3 triple negative breast cancer after surgery and standard treatments.
Patient Parameters
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Program Overview
The purpose of this study is to find out if a new vaccine, combined with the drug sargramostim (GM-CSF) and chemotherapy drug cyclophosphamide, can help prevent triple negative breast cancer from coming back after surgery and other treatments. The vaccine is made from a person's white blood cells mixed with tumor proteins to help the body build an immune response to fight cancer cells. Cyclophosphamide is a chemotherapy drug that works by stopping cancer cells from growing and spreading. This study will compare the effectiveness of the vaccine and GM-CSF with cyclophosphamide against GM-CSF alone.
Description
The main goal of this study is to see if the new vaccine, combined with GM-CSF, can help patients with triple negative breast cancer live longer without the disease coming back, compared to using GM-CSF alone. Another goal is to compare the safety and side effects of using cyclophosphamide with the vaccine and GM-CSF versus using GM-CSF alone.
The study will also look at whether certain immune responses or tumor characteristics can predict how well the vaccine works or if the cancer will return.
Participants will be randomly assigned to one of two groups:
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Group 1: Participants will take cyclophosphamide pills twice a day for one week in the first cycle. Starting in the second cycle, they will receive the vaccine with GM-CSF as an injection every 28 days for six cycles, and then every six months for up to 14 cycles, unless the cancer progresses or side effects become too severe.
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Group 2: Participants will take cyclophosphamide as in Group 1. Starting in the second cycle, they will receive a placebo vaccine with GM-CSF as an injection on the same schedule as Group 1.
After finishing the study treatment, participants will have follow-up visits every six months for three years.
Eligibility Criteria
Inclusion Criteria
- Women aged 18 years or older.
- Have had surgery to remove breast cancer, with no signs of cancer spread.
- Cancer must be triple negative, meaning it does not have estrogen, progesterone, or HER2 receptors.
- Completed all planned cancer treatments (surgery, radiation, chemotherapy) at least 90 days ago but not more than 546 days ago.
- Must have had certain types of cancer involvement or tumor size at diagnosis.
- Good overall health with a performance status of 0 or 1.
- Meet specific blood count and organ function requirements.
- Negative pregnancy test for women who can become pregnant.
- Willing to provide tissue and blood samples for research.
- Agree to return for follow-up visits and provide informed consent.
Exclusion Criteria
- Pregnant or breastfeeding women, or women who do not agree to use contraception.
- Evidence of cancer recurrence or spread.
- Allergic to GM-CSF.
- Active autoimmune disease needing treatment in the last 30 days.
- Serious uncontrolled health conditions.
- History of another cancer within the last 5 years, except for certain skin or cervical cancers.
- Recent use of certain medications or treatments that could interfere with the study.
- Immunocompromised individuals or those with HIV on antiretroviral therapy.
- Previous use of certain cancer therapies like trastuzumab or PD-1/PD-L1 inhibitors unless used more than 3 months ago.
Locations
| FACILITY | ZIP | CITY | STATE |
|---|---|---|---|
| Mayo Clinic in Arizona | 85259 | Scottsdale | Arizona |
| City of Hope Comprehensive Cancer Center | 91010 | Duarte | California |
| Mayo Clinic in Florida | 32224-9980 | Jacksonville | Florida |
| University of Miami Miller School of Medicine-Sylvester Cancer Center | 33136 | Miami | Florida |
| University of Chicago Comprehensive Cancer Center | 60637 | Chicago | Illinois |
| Carle Cancer Center NCI Community Oncology Research Program | 61801 | Urbana | Illinois |
| Ochsner Medical Center Jefferson | 70121 | New Orleans | Louisiana |
| Massachusetts General Hospital Cancer Center | 02114 | Boston | Massachusetts |
| Dana-Farber Cancer Institute | 02215 | Boston | Massachusetts |
| Mayo Clinic in Rochester | 55905 | Rochester | Minnesota |
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