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ACTIVE_NOT_RECRUITINGPHASE1

Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy

A Phase 1B Clinical Trial to Evaluate the Safety and Immune Response to a Mammaglobin-A DNA Vaccine in ER+, HER2- Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy or Chemotherapy

NCT02204098•Washington University School of Medicine

View on ClinicalTrials.gov

Summary

The purpose of this research study is to find out about the safety of injecting the gene (DNA) for mammaglobin-A into people with breast cancer. The DNA used in this study was purified from bacteria and contains the gene for mammaglobin-A. Mammaglobin-A is a protein that is highly expressed by breast cancer cells. Injection of mammaglobin-A DNA may be a way to generate an immune response to breast cancer cells. There is evidence that an immune response may be a way to fight cancer. In addition to evaluating the safety of the mammaglobin-A injection, this study is also looking at the immune response that the participant's body has after each injection.

Eligibility

Age

18 - No limit years

Sex

FEMALE

Healthy Volunteers

Inclusion Criteria

•A patient will be eligible for inclusion in this study only if ALL of the following criteria apply:
•Newly diagnosed histologically confirmed invasive breast cancer.
•At least 1 measurable lesion.
•Candidate for neoadjuvant endocrine therapy or chemotherapy.
•At least 18 years of age.
•Eastern Cooperative Oncology Group (ECOG) performance status ≤2.
•Adequate organ and marrow function no more than 28 days prior to the start of neoadjuvant endocrine therapy or chemotherapy as defined below:
•* WBC ≥3,000/μL
•* absolute neutrophil count ≥1,500/μL
•* platelets ≥100,000/μL
+7 more criteria

Exclusion Criteria

•A patient will be ineligible for inclusion in this study if ANY of the following criteria apply:
•Received any of the following for treatment of this cancer (except for the neoadjuvant endocrine therapy or chemotherapy specified within this protocol):
•* Surgery
•* Radiation therapy
•* Chemotherapy
•* Biotherapy
•* Hormonal therapy
•* Investigational agent Note that subjects who do not respond initially to endocrine therapy may receive chemotherapy and remain on study.
•Receiving any other investigational agent(s) or has received an investigational agent within the last 30 days.
•Known metastatic disease.
+14 more criteria

Locations (1)

Washington University School of Medicine

St Louis, Missouri, United States

Key Dates

Start Date

January 7, 2015

Primary Completion Date

April 6, 2022

Completion Date

August 31, 2028

Last Updated

April 17, 2025

Enrollment

ACTUAL participants

Conditions

Breast CancerBreast CarcinomaMalignant Neoplasm of Breast

Interventions

Mammaglobin-A DNA Vaccine

BIOLOGICAL

Optional biopsy

PROCEDURE

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RECRUITINGPHASE2

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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Anatomic Stage III Breast Cancer AJCC v8Anatomic Stage IV Breast Cancer AJCC v8+29 more

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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: April 17, 2025Data 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.

View ClinicalTrials.gov Terms and Conditions

Safety and Immune Response to a Mammaglobin-A DNA Vaccine In Breast Cancer Patients Undergoing Neoadjuvant Endocrine Therapy

Inclusion Criteria

Exclusion Criteria

Safety and Feasibility of Robotic SP Nipple Sparing Mastectomy

Measuring the Effects of Talazoparib in Patients With Advanced Cancer and DNA Repair Variations

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