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.

Condition

Eligibility

Eligible Ages
Over 18 Years
Eligible Genders
Female
Accepts Healthy Volunteers
No

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.

Study Design

Phase
Phase 2
Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Standard Chemotherapy
The first or "control" arm will receive standard chemotherapy for triple negative breast cancer.
  • Biological: P10s-PADRE with MONTANIDE™ ISA 51 VG
    Vaccination with standard chemotherapy
    Other names:
    • Chemovax
  • Drug: Standard Chemotherapy
    Standard chemotherapy only
Active Comparator
Standard Chemotherapy + Vaccine
The second or "chemo + vaccine" arm will receive the same standard chemotherapy plus P10s-PADRE vaccine.
  • Biological: P10s-PADRE with MONTANIDE™ ISA 51 VG
    Vaccination with standard chemotherapy
    Other names:
    • Chemovax
  • Drug: Standard Chemotherapy
    Standard chemotherapy only

Recruiting Locations

Highlands Oncology Group
Fayetteville, Arkansas 72703
Contact:
J T Beck, MD

University of Arkansas for Medical Sciences
Little Rock, Arkansas 72205
Contact:
Sandy Annis
amannis@uams.edu

More Details

NCT ID
NCT02938442
Status
Recruiting
Sponsor
University of Arkansas

Study Contact

Issam Makhoul, MD
5016868274
makhoulissam@uams.edu

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.

Notice

Study information shown on this site is derived from ClinicalTrials.gov (a public registry operated by the National Institutes of Health). The listing of studies provided is not certain to be all studies for which you might be eligible. Furthermore, study eligibility requirements can be difficult to understand and may change over time, so it is wise to speak with your medical care provider and individual research study teams when making decisions related to participation.