Clinical Trials /

Vaccination of Triple Negative Breast Cancer Patients

NCT02938442

Description:

The purpose of this research is to compare the effect on breast cancer of using a new experimental breast cancer vaccine (used to stimulate immune cell production) with chemotherapy and surgery versus the usual treatment of chemotherapy and surgery.

Related Conditions:
  • Breast Carcinoma
Recruiting Status:

Recruiting

Phase:

Phase 2

Trial Eligibility

Document

Title

  • Brief Title: Vaccination of Triple Negative Breast Cancer Patients
  • Official Title: A Combined Phase II Efficacy Study of a Carbohydrate Mimotope-based Vaccine With MONTANIDE™ ISA 51 VG Combined With Neoadjuvant Chemotherapy in Triple Negative Breast Cancer

Clinical Trial IDs

  • ORG STUDY ID: 206010
  • SECONDARY ID: 206010
  • NCT ID: NCT02938442

Conditions

  • Breast Neoplasms

Interventions

DrugSynonymsArms
P10s-PADRE with MONTANIDE™ ISA 51 VGChemovaxStandard Chemotherapy + Vaccine
Standard ChemotherapyStandard Chemotherapy

Purpose

The purpose of this research is to compare the effect on breast cancer of using a new experimental breast cancer vaccine (used to stimulate immune cell production) with chemotherapy and surgery versus the usual treatment of chemotherapy and surgery.

Detailed Description

      The purpose of this study is to evaluate an investigational agent, P10s-PADRE, a peptide
      mimotope-based vaccine, in combination with standard neoadjuvant chemotherapy in patients
      with clinical stage I, II or III estrogen-receptor (ER) negative, progesterone receptor (PR)
      negative and HER2-negative (= triple negative - TN) breast cancer. P10s-PADRE will be
      administered with MONTANIDE™ ISA 51 VG as adjuvant. Human breast cancers that express Tumor
      Associated Carbohydrate Antigens (TACAs) can be immunogenic, and enhancing the anti-TACA
      antibodies and immune effector function already present may augment the cytotoxic effects of
      standard therapies.

      A randomized two-arm, open-label, multi-center phase II trial is designed with the goal being
      to evaluate the efficacy of combining vaccination of the P10s-PADRE formulation with
      neoadjuvant chemotherapy. Patients will be randomly assigned in a 2:1 ratio to standard
      chemotherapy plus P10s-PADRE or to standard chemotherapy alone. Efficacy will be based on the
      rate of pathologic Complete Response (pCR) observed among TN breast-cancer patients treated
      with the combination as compared with the group of patients who receive standard chemotherapy
      alone.
    

Trial Arms

NameTypeDescriptionInterventions
Standard ChemotherapyActive ComparatorThe first or "control" arm will receive standard chemotherapy for triple negative breast cancer.
  • Standard Chemotherapy
Standard Chemotherapy + VaccineActive ComparatorThe second or "chemo + vaccine" arm will receive the same standard chemotherapy plus P10s-PADRE vaccine.
  • Standard Chemotherapy

Eligibility Criteria

        Inclusion Criteria:

          -  Females of all races with biopsy-proven clinical stage II, or III TN breast cancer who
             will undergo standard neoadjuvant treatment

          -  Age 18 years and older

          -  ECOG Performance Status 0 or 1.

          -  White blood cell (WBC) count ≥ 3,000/mm3 within 3 weeks prior to registration.

          -  Platelet count ≥ 100,000/mm3 within 3 weeks prior to registration.

          -  Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL)
             of normal obtained within 3 weeks prior to registration or Aspartate aminotransferase
             test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks
             prior to registration.

          -  Serum glutamic pyruvic transaminase (SGPT) ≤ 2 x institutional upper limit (IUL) of
             normal obtained within 3 weeks prior to registration or Alanine Aminotransferase (ALT)
             ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks prior to
             registration.

          -  Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 3 weeks
             prior to registration.

          -  Serum creatinine ≤ 1.8 mg/dl obtained within 3 weeks prior to registration.

          -  Must sign an informed consent document approved by the UAMS Institutional Review Board
             (IRB).

        Exclusion Criteria:

          -  Active infection requiring treatment with antibiotics.

          -  Existing diagnosis or history of organic brain syndrome that might preclude
             participation in the full protocol.

          -  Existing diagnosis or history of significant impairment of basal cognitive function
             that might preclude participation in the full protocol.

          -  Other current malignancies. Subjects with prior history at any time of any in situ
             cancer, including lobular carcinoma of the breast in situ, cervical cancer in situ,
             atypical melanocytic hyperplasia or Clark I melanoma in situ or basal or squamous skin
             cancer are eligible, provided they are disease-free at the time of registration.
             Subjects with other malignancies are eligible if they have been continuously disease
             free for ≥ 5 years prior to the time of registration.

          -  Existing diagnosis or history of autoimmune disorders or conditions of
             immunosuppression. This includes, but is not limited to being treated with
             corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when
             used as an antiemetic in standard therapy]), continuous use of topical steroid creams
             or ointments or any steroid-containing inhalers. Subjects who discontinue the use of
             these classes of medication for at least 6 weeks prior to registration are eligible
             if, in the judgment of the treating physician, the subject is not likely to require
             these classes of drugs during the treatment period. Replacement doses of steroids for
             subjects with adrenal insufficiency are allowed.

          -  Pregnancy or breast feeding (due to the unknown effects of peptide/mimotope vaccines
             on a fetus or infant). Women of childbearing potential must have a negative urine
             pregnancy test within 72 hours prior to starting week 1 and must be counseled to use
             an accepted and effective method of contraception (including abstinence) while on
             treatment and for a period of 18 months after completing or discontinuing treatment.
             Accepted methods of contraception include oral contraceptives, barrier methods, IUDs,
             and abstinence.

          -  Any other significant medical or psychiatric conditions which, in the opinion of the
             enrolling investigator, may interfere with consent or compliance of the treatment
             regimen.
      
Maximum Eligible Age:N/A
Minimum Eligible Age:18 Years
Eligible Gender:Female
Healthy Volunteers:No

Primary Outcome Measures

Measure:rate of pCR in breast and axillary lymph nodes
Time Frame:at the time of definitive surgery
Safety Issue:
Description:

Details

Phase:Phase 2
Primary Purpose:Interventional
Overall Status:Not yet recruiting
Lead Sponsor:University of Arkansas

Last Updated

November 8, 2017