Status:
ACTIVE_NOT_RECRUITING
HER2 Directed Dendritic Cell Vaccine During Neoadjuvant Therapy of HER2+Breast Cancer
Lead Sponsor:
H. Lee Moffitt Cancer Center and Research Institute
Collaborating Sponsors:
United States Department of Defense
Conditions:
Breast Cancer
Breast Cancer Female
Eligibility:
All Genders
18+ years
Phase:
EARLY_PHASE1
Brief Summary
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 aggres...
Detailed Description
The trial will consist of two phases. The first lead in phase will enroll 12 participants evenly divided into two arms (alternating enrollment) with different initial priming study vaccination schedul...
Eligibility Criteria
Inclusion
- Participants must have histologically confirmed clinical stage II or III ERPR- HER2+ (per CAP criteria) invasive carcinoma of the breast
- Medically and surgically appropriate to undergo neoadjuvant chemotherapy with TCH-P Taxotere (docetaxel), Carboplatin, Herceptin (trastuzumab), Perjeta (pertuzumab) regimen followed by standard of care local therapy as determined by their treating physician
- Age ≥18 years.
- Eastern Cooperative Oncology Group (ECOG) performance status less than 2
- 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. Should a woman become pregnant or suspect she is pregnant while participating in this study, she should inform her treating physician immediately. Sexually active male participants should use a barrier method or exercise abstinence during chemotherapy administration until surgery.
- Ability to understand and the willingness to sign a written informed consent document.
Exclusion
- Patients with inflammatory breast cancer, widespread locally advanced unresectable disease involving the chest wall/nodal basins in which a curative surgical resection cannot be performed, or those in whom de novo metastatic disease is suspected or confirmed
- May not be receiving any other investigational agents for the treatment of their breast cancer.
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to the study vaccine components and any of the chemotherapy drugs (docetaxel, carboplatin, trastuzumab, pertuzumab)
- Unwilling or unable to undergo an apheresis for production of their vaccine
- 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.
- Women who are pregnant or breastfeeding
- Known congenital or acquired immune deficiency (including those patients who require systemic immunosuppressant drugs for autoimmune disease or organ transplant).
- Pre-existing peripheral neuropathy that would limit treatment with taxanes and platinum agents
Key Trial Info
Start Date :
June 6 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 29 2026
Estimated Enrollment :
31 Patients enrolled
Trial Details
Trial ID
NCT03387553
Start Date
June 6 2018
End Date
August 29 2026
Last Update
November 14 2025
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
H. Lee Moffitt Cancer Center and Research Institute
Tampa, Florida, United States, 33612