Active — Not RecruitingPhase 1

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

United States27 participantsStarted 2015-01-07

Plain-language 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.

Who can participate

Age range

18 Years

Sex

FEMALE

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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. * Clinical T2-T4c, any N, M0 invasive ER+ (Allred Score of 6-8) and HER2- (0 or 1+ by IHC or FISH negative for amplification) breast cancer by AJCC 7th edition clinical staging, with the goal being surgery to completely excise the tumor in the breast and the lymph node. Patients with T1c tumors are eligible if they are considered candidates for neoadjuvant endocrine therapy or chemotherapy * 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 * total bilirubin ≤institutional upper limit of normal * AST/ALT ≤2.5 X institutional upper limit of normal * creatinine ≤ institutional upper limit of normal OR creatinine clearance ≥ 60 mL/min/1.73 m2 for patients with creatinine above IULN * Postmenopausal or premenopausal. NOTE: Postmenopausal women, verified by: (1) bilateral surgical oophorectomy, or (2) no spontaneous menses ≥ 1 year or (3) no menses for \<1 year with FSH and estradiol levels in postmenopausal range, according to i…

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Safety as measured by the number of participants who experience an adverse event

Timeframe: Day 126 (+/- 7days)

Trial details

NCT IDNCT02204098

SponsorWashington University School of Medicine

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-04-06

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