Study on TPIV100 and Sargramostim for Treating HER2 Positive Stage II-III Breast Cancer with Remaining Disease After Chemotherapy and Surgery
Sponsor: Academic and Community Cancer Research United
ClinicalTrials ID:NCT04197687
This clinical trial is exploring how well a new vaccine, TPIV100, combined with sargramostim, works in treating patients with HER2 positive breast cancer that still has some disease left after chemotherapy and surgery. The study also looks at why some patients respond better to chemotherapy with trastuzumab and pertuzumab.
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Program Overview
This study is testing a new treatment approach for patients with HER2 positive breast cancer that still has some disease remaining after chemotherapy and surgery. The treatment involves a vaccine called TPIV100, which is designed to help the immune system target and destroy cancer cells that express HER2. Sargramostim is used to boost white blood cell production and alert the immune system. The study aims to find out if this combination is more effective than current treatments.
Description
The main goals of this study are to see if the new HER2 vaccine, TPIV100, can help prevent the return of breast cancer and to check its safety when used with a standard treatment called ado-trastuzumab emtansine (T-DM1). Researchers will also look at how the vaccine affects the immune system and if it can improve the body's response to cancer.
Patients who have some cancer left after initial chemotherapy and surgery will be divided into two groups. One group will receive the standard treatment with T-DM1 and the TPIV100 vaccine, while the other group will receive the standard treatment with a placebo instead of the vaccine. Both groups will also receive sargramostim to help boost their immune system. The treatment will be given every 21 days for up to 6 cycles, with additional booster shots at 3 and 12 months after completing T-DM1 therapy.
The study will also explore how the immune system and cancer cells interact and what factors might influence the success of the treatment. This includes looking at specific immune cells and genetic markers that could predict how well patients respond to the vaccine.
Eligibility Criteria
Inclusion Criteria
- Diagnosed with stage II-III HER2 positive breast cancer with remaining disease after chemotherapy and surgery.
- Willing to provide a biopsy sample before starting the study.
- Good overall health with an ECOG performance status of 0, 1, or 2.
- Agree to use effective contraception during the study and for 6 months after the last vaccine dose.
- Willing to receive a tetanus shot if not done within the past year.
- Able to provide written consent and return for follow-up visits.
- Negative pregnancy test for women of childbearing potential.
- Meet specific blood count and organ function requirements.
- Completed planned breast surgeries and any radiation therapy at least 30 days before joining the study.
- Completed last cycle of chemotherapy at least 90 days before joining the study.
- Have adequate tissue samples from both pre-treatment biopsy and surgery.
Exclusion Criteria
- Pregnant or breastfeeding women, or those unwilling to use contraception.
- Evidence of cancer recurrence or spread to other parts of the body.
- Severe health conditions that could interfere with the study.
- Immunocompromised patients or those on chronic steroids.
- Uncontrolled illnesses like heart failure or infections.
- Receiving other investigational treatments.
- Other active cancers within the past 3 years, except for certain skin or cervical cancers.
- History of autoimmune diseases requiring recent treatment.
- Allergic reactions to sargramostim or trastuzumab-related heart issues.
- Recent heart attack or heart failure requiring ongoing treatment.
- Recent use of tamoxifen or similar drugs for breast cancer prevention.
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