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Pilot Study of a Breast Cancer Vaccine Plus Poly-ICLC for Breast Cancer (Breast 41)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT01532960
Recruitment Status : Terminated (Futility for immune responses to the vaccine. Also, a component of study drug was in short supply.)
First Posted : February 15, 2012
Last Update Posted : May 8, 2020
Information provided by (Responsible Party):
Craig L Slingluff, Jr, University of Virginia

Brief Summary:
Despite advances in surgical, radiation and medical therapies of early stage breast cancer, some patients will experience disease recurrence. Because recurrence may not happen for years after definitive treatment, there is a period of time between resection and relapse when micrometastatic disease may be amenable to immune eradication or modulation. While the ultimate goal of any cancer treatment is clinical efficacy, the immediate urgency in breast immunotherapy is to define treatments that have immunologic efficacy. In this study, the investigators will determine whether a vaccine consisting of nine-class I breast specific peptides plus a class II tetanus toxoid helper peptide is immunogenic when administered with poly-ICLC to participants with stage IB to IIIA breast cancer in the adjuvant setting.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: poly-ICLC Biological: 9 Peptides from Her-2/neu, CEA, & CTA Biological: Peptide-tet Phase 1

Detailed Description:

The study is a single arm, open label, pilot study of safety and immune efficacy of peptide vaccination with poly-ICLC in patients with stage IB-IIIA resected breast cancer. Participants will be patients who have completed their last dose/treatment of any single treatment or combination of adjuvant surgery, radiation, chemotherapy or trastuzumab therapy between 45 days and 6 months (180 days) prior to enrollment.

Each vaccination will be administered on days 1, 8, 15, 36, 57, and 78. All participants will receive 9 class I MHC-restricted synthetic peptides (restricted by HLA-A1, -A2, -A3, or -A31) and a class II MHC-restricted tetanus helper peptide mixed with 1mg poly-ICLC and administered in sterile water. The vaccine will be administered intramuscular (IM) (1 ml) and intradermally (ID) (1 ml) at vaccination sites in the arm and leg. (Each vaccine given IM and ID at one site; site to alternate between arm site opposite the breast cancer and an anterior thigh site.) Participants will be screened for HLA type and must be HLA-A1, -A2, -A3, or -A31 (80% of the Virginia population in prior studies1).

Annual follow-up for progression and survival for 3 years after study withdrawal/completion.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Pilot Study of the Immunogenicity of a 9-Peptide Breast Cancer Vaccine Plus Poly-ICLC in Stage I-IV Breast Cancer
Study Start Date : July 2012
Actual Primary Completion Date : September 2015
Actual Study Completion Date : September 2015

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: 9 Peptides from Her-2/neu, CEA, & CTA, peptide-tet, poly-ICLC
9 class I MHC-restricted synthetic peptides (100 mcg each peptide) derived from breast cancer associated proteins, a class II MHC-restricted tetanus derived peptide (200 mcg), plus polyICLC (1 mg).
Biological: poly-ICLC

Biological: 9 Peptides from Her-2/neu, CEA, & CTA
9 synthetic peptides derived from Her-2/neu, CEA & CTA derived breast cancer proteins.

Biological: Peptide-tet
A class II MHC-restricted helper peptide derived from tetanus toxoid protein.

Primary Outcome Measures :
  1. Safety (Frequency of dose limiting adverse events) [ Time Frame: 30 days post-administration of the last vaccine ]
  2. Immune response rate [ Time Frame: through day 108 ]
    Measured as the number of IFN-gamma producing cells in the blood in response to the vaccine.

Secondary Outcome Measures :
  1. Safety (adverse event profile) [ Time Frame: 30 days post-administration of the last vaccine ]
  2. Immunogenicity- CD8+ T cell specificity [ Time Frame: through day 108 ]
    Characterize vaccine specific peripheral CD8+ T-cell specificity by tetramer staining and flow cytometric analysis

  3. Immunogenicity- CD8+ cytokine production [ Time Frame: through day 108 ]
    Estimate the Tc1/Tc2 cytokine production bias of circulating vaccine-specific T cells.

  4. Immunogenicity- immue responses among subjects treated with anti-estrogen therapies [ Time Frame: through day 108 ]
    Using the ELIspot assay, describe the frequency of immune responses among patients treated with anti-estrogen therapies

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No


  • Patients who have been diagnosed with clinical or pathologic stage I to stage IV adenocarcinoma of the breast (any subtype) who have undergone, and recovered from primary therapy (any combination of surgery, radiation, and/or chemotherapy and/or HER2-directed therapy), with their last dose/treatment (of any single or combination treatment) being between 28 days and 36 months prior to enrollment. Staging will be based on the Seventh Edition AJCC staging system. (Systemic staging with CT or PET scans is not required by AJCC and is not required or exclusionary for this trial).
  • Stage IA patients must be high risk based upon triple negative status or HER2+ status
  • Patients may or may not be receiving hormonal therapy at the time of study entry.
  • Age ≥ 18 years at the time of enrollment
  • ECOG performance status of 0 or 1
  • Ability and willingness to give informed consent
  • HLA-A1, -A2, -A3, or -A31 positive
  • Adequate organ function
  • HIV and Hepatitis C negative
  • Subjects must have a minimum of two intact lymph node basins (any combination of axillary and inguinal basins that have not undergone complete nodal dissection)

Exclusion Criteria

  • Known or suspected allergies to any component of the vaccine
  • Active infection requiring antibiotics are excluded.
  • The following medications or treatments within the 4 weeks (28 days) prior to consenting. These medication and treatments may not be re-started at any time throughout the study in order to remain eligible.

    • Breast tumor resection surgery (reconstructive surgery permitted)
    • Chemotherapy
    • Radiation therapy
    • Allergy desensitization injections
    • Growth factors (e.g., Procrit®, Aranesp®, Neulasta®)
    • Other agents with putative immunomodulating activity (with the exception of non-steroidal anti-inflammatory agents)
    • Any investigational medication
  • Tthe following medications or treatments within the 4 weeks (28 days) prior to consenting:

    • Corticosteroids, administered parenterally, orally, or inhaled (Inhaled steroids, such as: Advair®, Flovent®, Azmacort.®)
    • Topical corticosteroids are acceptable.
  • Previous vaccination with any of the synthetic peptides included in this protocol.
  • Active tuberculosis and not on active antitubercular agents
  • Pregnancy.
  • Female subjects must not be breastfeeding
  • A medical contraindication or potential problem in complying with the requirements of the protocol, in the opinion of the investigator
  • New York Heart Association classification as having Class III or IV heart disease
  • Stage IV subjects who have anticipated chemotherapy need within the 108 day treatment period for this trial.
  • Subjects that have experienced active autoimmune disorders requiring cytotoxic or immunosuppressive therapy within the 6 weeks (42 days) prior to consenting.

    • The following will not be exclusionary:

      • The presence of laboratory evidence of autoimmune disease (e.g., positive ANA titer) without symptoms
      • Clinical evidence of vitiligo
      • Other forms of depigmenting illness
      • Mild arthritis requiring NSAID medications

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT01532960

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United States, Virginia
University of Virginia Health System
Charlottesville, Virginia, United States, 22908
Sponsors and Collaborators
Craig L Slingluff, Jr
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Principal Investigator: Patrick M Dillon, MD University of Virginia
Publications automatically indexed to this study by Identifier (NCT Number):
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Responsible Party: Craig L Slingluff, Jr, Director, Human Immune Therapy Center, University of Virginia Identifier: NCT01532960    
Other Study ID Numbers: 15881
First Posted: February 15, 2012    Key Record Dates
Last Update Posted: May 8, 2020
Last Verified: May 2020
Keywords provided by Craig L Slingluff, Jr, University of Virginia:
breast cancer
peptide vaccine
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Interferon Inducers
Immunologic Factors
Physiological Effects of Drugs