Clinical Trials Logo
  1. Home
  2. Breast Ductal Carcinoma in Situ
  3. NCT04144023

A Vaccine (H2NVAC) Before Surgery for the Treatment of HER2-Expressing Ductal Carcinoma In Situ

Breast Ductal Carcinoma In Situ Clinical Trial

Official title:
A Phase IB Trial of Neoadjuvant Multi-Epitope HER2 Peptide Vaccine in Patients With HER2-Expressing DCIS

Clinical Trial Summary

This phase Ib trial studies the side effects and best dose of a vaccine called H2NVAC before surgery in treating patients with HER2 expressing ductal carcinoma in situ. H2NVAC is a vaccine designed to stimulate specialized white blood cells in hopes of increasing immune response and protecting against breast cancer.

Clinical Trial Description

PRIMARY OBJECTIVES: I. To determine the safety and tolerability of multi-epitope HER2 peptide vaccine H2NVAC (H2NVAC) given for 4 treatments in patients with HER2-expressing ductal carcinoma in situ (DCIS) prior to surgery. II. To determine the dose level of H2NVAC with maximum systemic and intratumoral immunogenicity as measured by activated HER2-specific T lymphocytes or high-affinity antibodies. SECONDARY OBJECTIVES: I. To determine intratumoral immunogenicity of H2NVAC in patients with HER2-expressing DCIS. II. To assess the complete pathological response after 4 treatments of neoadjuvant H2NVAC. III. To assess the systemic immunogenicity of H2NVAC in patients with HER2-expressing DCIS. IV. To assess changes in HER2 expression in the DCIS after 4 treatments of neoadjuvant H2NVAC. V. To assess the distribution of the helper T cell response among T helper cell differentiation states. OUTLINE: This is a dose-escalation study of multi-epitope HER2 peptide vaccine H2NVAC. Prior to standard of care surgery, patients treated at dose levels 1 and 2 receive granulocyte macrophage-colony-stimulating factor (GM-CSF) admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on day 1 of each cycle. Treatment repeats every 14 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. Patients treated at dose level 3 receive GM-CSF admixed with multi-epitope HER2 peptide vaccine H2NVAC intradermally on days 1, 4, 8, and 15 for 1 cycle. Patients also undergo echocardiography (ECHO) and collection of blood samples throughout the trial and may undergo biopsy on trial. After completion of study treatment, patients are followed up at 3, 6, and 12 months after surgery and optionally at 18 and 24 months after surgery. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details
NCT number NCT04144023
Study type Interventional
Source Mayo Clinic
Contact
Status Recruiting
Phase Phase 1
Start date June 27, 2019
Completion date December 31, 2024
View Details
See also
  Status Clinical Trial Phase
Not yet recruiting NCT05941520 - Acolbifene Versus Low Dose Tamoxifen for the Prevention of Breast Cancer in Premenopausal Women at High Risk for Development of Breast Cancer Phase 2
Active, not recruiting NCT05086705 - EMBr Wave for the Reduction of Hot Flashes in Women With a History of Breast Cancer N/A
Active, not recruiting NCT03317405 - Phase I Trial of Endoxifen Gel Versus Placebo in Women Undergoing Breast Surgery Phase 1
Recruiting NCT05545150 - Volumetric Specimen Imager Device for the Intraoperative Imaging of Patients With Breast Carcinoma and Breast Ductal Carcinoma In Situ, The VIVID Study Phase 2
Not yet recruiting NCT06184750 - Finding the Best Tamoxifen Dose for Breast Cancer Risk Reduction in Premenopausal Women, RENAISSANCE Trial Phase 2
Active, not recruiting NCT00769379 - Radiation Therapy With or Without Trastuzumab in Treating Women With Ductal Carcinoma In Situ Who Have Undergone Lumpectomy Phase 3
Active, not recruiting NCT05012176 - An Episodic Future Thinking Intervention to Promote Weight Loss in Breast Cancer Survivors N/A
Recruiting NCT04169542 - Impact of COVID-19 Pandemic on Out-of-Pocket Costs, Lost Wages, and Unemployment in Patients With Breast Cancer Undergoing Breast Surgery
Recruiting NCT04494945 - Identifying and Caring for Individuals With Inherited Cancer Syndrome N/A
Terminated NCT02876640 - Retinoid 9cUAB30 in Producing a Biologic Effect in Patients With Early Stage Breast Cancer Phase 1
Recruiting NCT05340673 - Comparing Supplemental Topical Agents for the Treatment of Acute Radiation Dermatitis in Patients With Breast Cancer Phase 1
Not yet recruiting NCT06195306 - Low Dose Tamoxifen With or Without Omega-3 Fatty Acids for Breast Cancer Risk Reduction Phase 2
Recruiting NCT06350500 - A Patient Navigation Program for Addressing Disparities in Breast Cancer Care N/A
Completed NCT03323658 - Bexarotene in Preventing Breast Cancer in Patients at High Risk for Breast Cancer Phase 1
Completed NCT02636582 - Nelipepimut-S Plus GM-CSF Vaccine Therapy in Treating Patients With Breast Cancer Phase 2
Completed NCT04022772 - Effect of PACK Health Support Program on Patient Reported Outcomes in Patients With Breast Cancer N/A
Suspended NCT05327608 - Intermittent Fasting for the Improvement of Outcomes in Patients With Stage I-III Breast Cancer Receiving Chemotherapy Before Surgery N/A
Active, not recruiting NCT01272037 - Tamoxifen Citrate, Letrozole, Anastrozole, or Exemestane With or Without Chemotherapy in Treating Patients With Invasive RxPONDER Breast Cancer Phase 3
Recruiting NCT03979508 - Abemaciclib in Treating Patients With Surgically Resectable, Chemotherapy Resistant, Triple Negative Breast Cancer Phase 2
Recruiting NCT04959474 - SABR-CaRe in Early Stage Breast Cancer Phase 2