Dendritic Cell Vaccine for Breast Cancer

Recruiting in Palo Alto (17 mi)

Overseen byHaten Soliman, M.D.

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase < 1

Waitlist Available

Sponsor: H. Lee Moffitt Cancer Center and Research Institute

No Placebo Group

Trial Summary

What is the purpose of this trial?The purpose of this study is to learn more about how to treat patients with HER-2/neu positive invasive breast cancer (IBC). HER-2/neu is a type of protein that is known to be over-expressed in aggressive breast cancer. The study drug for this trial is DC1 study vaccine which is a HER2-sensitized dendritic cell (DC) study vaccine. This study vaccine is made from the participant's blood cells collected from a procedure called leukapheresis. Dendritic cells are immune cells that can tell the immune system to fight infection. In laboratory testing and from previous studies in participants, these cells may also help the immune system attack tumors such as breast cancer.

Eligibility Criteria

This trial is for adults with stage II or III HER2+ invasive breast cancer, who are in good health otherwise, with normal organ and marrow function. They must not be pregnant or breastfeeding, have no severe illnesses that could affect study participation, and agree to use contraception. It's not for those with inflammatory breast cancer, uncontrolled diseases like heart failure or arrhythmias, immune deficiencies, certain allergies to vaccine components or chemotherapy drugs.

Inclusion Criteria

My doctor agrees I can have specific chemotherapy and follow-up care.

I am 18 years old or older.

Patients must have normal organ and marrow function as defined below: leukocytes ≥3,000/μL, absolute neutrophil count ≥1,500/μL, platelets ≥100,000/μL, total bilirubin within normal institutional limits, AST(SGOT)/ALT(SGPT) less than or equal to 2.5 X institutional upper limit of normal, creatinine within normal institutional limits - OR - creatinine clearance ≥60 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal, cardiac ejection fraction within institutional normal limits by either MUGA or ECHO at baseline, women of child-bearing potential and their male partners must agree to use adequate contraception (hormonal or barrier method of birth control; abstinence) prior to study entry and for the duration of study participation, ability to understand and the willingness to sign a written informed consent document

+2 more

Exclusion Criteria

I have an immune deficiency or take drugs to suppress my immune system.

I am not allergic to the study vaccine or similar chemotherapy drugs.

I have nerve damage that prevents me from receiving certain chemotherapy drugs.

+5 more

Participant Groups

The trial tests a new type of treatment called DC1 dendritic cell vaccine alongside standard neoadjuvant chemotherapy (TCH-P regimen) before surgery. The DC1 vaccine is made from the patient's own blood cells and aims to boost the immune system to fight breast cancer more effectively.

3Treatment groups

Experimental Treatment

Active Control

Group I: Expansion PhaseExperimental Treatment3 Interventions

DC1 vaccinations according to optimal vaccination schedule. Participants will receive a booster intranodal study vaccine at week 25 prior to receiving surgery. Participants will then undergo definitive curative surgery following completion of the neoadjuvant therapy, additional adjuvant locoregional/systemic therapy (as deemed appropriate by their treating physicians).

Group II: Lead In Phase - Arm AActive Control3 Interventions

Arm A: One Dendritic Cell Vaccine (DC1) per week x 3 weeks.

Group III: Lead In Phase - Arm BActive Control3 Interventions

Arm B: Two DC1 vaccinations per week (given 3 days apart i.e., Mon and Thurs or Tues and Friday) x 3 weeks.