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Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer | Clinical Trials | Clareo Health

COMPLETEDPHASE1/PHASE2

Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer

Pilot Safety Trial of Preoperative Chemotherapy Combined With Dendritic Cell Vaccine in Patients With Locally Advanced, Triple-Negative Breast Cancer or ER-Positive, Her2-Negative Breast Cancer

NCT02018458•Baylor Research Institute

View on ClinicalTrials.gov

Summary

The primary objective of this study is to determine the safety and feasibility of combining cyclin B1/WT-1/CEF (antigen)-loaded DC vaccination with preoperative chemotherapy. The secondary objectives of this trial are to determine pathologic complete response rates; disease-free survival; to assess immune biomarkers of immunity (antigen-specific CD8+ T cell immunity and TH2 T cells) in breast cancer biopsy specimens and blood samples in patients receiving DC vaccinations; and to assess the feasibility of immunizing LA TNBC and ER+/HER2- BC patients with patient-specific tumor antigens.

Detailed Description

Recent studies have shown that human breast cancers can be immunogenic, and that enhancing the immune effector function already present may augment the cytotoxic effects of standard therapies. vaccination remains the most attractive strategy because of its expected inducement of both therapeutic T cell immunity (effector T cells) and protective T cell immunity (tumor-specific memory T cells that can control tumor relapse). Several clinical studies have now demonstrated that immunity against tumor antigens can be enhanced in cancer patients by vaccination with ex vivo-generated tumor antigen-loaded dendritic cells (DCs). This strategy capitalizes on the unique capacity of DCs to prime lymphocytes and to regulate and maintain immune responses. Our goals are to boost T cell immunity targeted against breast cancer utilizing a tumor antigen-loaded DC vaccine, to enhance chemotherapy effectiveness and decrease tumor metastagenicity, and to decrease the recurrence rates of LA TNBC and ER+/HER2- BC. Patients will be treated with a combination of antigen-loaded DC vaccinations along with standard preoperative chemotherapy, to improve immunogenicity and to increase the pCR rate achieved with standard therapy. The trial will consist of 2 patient cohorts: TNBC and ER+/HER2- BC.

Eligibility

Age

18 - 80 years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•A patient will be considered for enrollment in this study if all of the following criteria are met:
•1. Female patients ≥18 years of age.
•2. Have either:
•2. High-risk ER+ breast cancer defined as grade 3 invasive ductal or mixed ductal/lobular cancers, or grade 2 with Ki67 ≥20%; node positive as evidenced by physical exam or imaging evaluation or histological evaluation.
•3. HER2- negative breast cancer. If HER2-, it is defined as follows:
•1. FISH-negative (FISH ratio \<2.0), or
•2. IHC 0-1+, or
•3. IHC 2+ AND FISH-negative (FISH ratio\<2.0)
•4. Eastern Cooperative Oncology Group (ECOG) Performance Status of 0-1
•5. Adequate hematologic function, defined by:
+12 more criteria

Exclusion Criteria

•A patient will be ineligible for inclusion in this study any of the following criteria are met:
•1. Evidence of metastatic disease on bone scan and CT scan of chest/abdomen (or PET CT scan). Patients with intrathoracic metastatic adenopathy are eligible.
•2. Active infection or unexplained fever \>38.5°C during screening.
•3. Active infections including viral hepatitis and HIV.
•4. Active asthma or other condition requiring steroid therapy.
•5. Autoimmune disease including lupus erythematosus or rheumatoid arthritis. Topical or inhaled corticosteroids are allowed.
•6. Patients who are currently receiving or who have received previous systemic therapy for breast cancer (eg, chemotherapy, antibody therapy, targeted agents).The use of an LHRH agonist during chemotherapy in premenopausal women who wish to preserve ovarian function is allowed, but is not required.
•7. Women who are pregnant or lactating. All patients with reproductive potential must agree to use effective contraception from time of study entry until at least 3 months after the last administration of study drug.
•8. Have a NYHA Class III or IV CHF or LVEF \<55%. Patients with significant cardiac disease history within 1 year or ventricular arrhythmias requiring medication are also excluded.
•9. Patients who have any severe and/or uncontrolled medical conditions or other conditions that could affect their participation such as:
+6 more criteria

Locations (1)

Baylor University Medical Center

Dallas, Texas, United States

Key Dates

Start Date

May 1, 2014

Primary Completion Date

September 18, 2019

Completion Date

September 18, 2019

Last Updated

October 11, 2021

Enrollment

ACTUAL participants

Conditions

Breast Cancer

Interventions

LA TNBC: DC vaccine+Preop chemo

BIOLOGICAL

ER+/HER2-BC:DC vaccine+Preop chemo

BIOLOGICAL

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: October 11, 2021Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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Safety Study Of Chemotherapy Combined With Dendritic Cell Vaccine to Treat Breast Cancer

Inclusion Criteria

Exclusion Criteria

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A Study of the Impact of Endocrine Therapy on Surgical Outcomes in People With Breast Cancer