Purpose

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)-positive breast cancer. This is a single-arm, multi-site Phase I/II study designed with the two goals being (1) to evaluate the feasibility of combining vaccination with the P10s-PADRE formulation with neoadjuvant chemotherapy and (2) to determine if the polymerase chain reaction (pCR) rate among ER-positive breast-cancer patients treated with the combination is significantly higher than the 8% rate observed among ER-positive breast-cancer subjects in a pooled analysis of seven randomized clinical trials. P10s-PADRE vaccine with MONTANIDE™ ISA 51 VG as adjuvant will be given in combination with neoadjuvant chemotherapy in female patients with clinical stage I, II or III ER-positive breast cancer.

Condition

Eligibility

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

Inclusion Criteria

  • Females of all races with clinical stage I, II, or III ER-positive breast cancer who qualify for standard neoadjuvant treatment
  • Age 18 years and older
  • Eastern Cooperative Oncology Group (ECOG) Performance Status 0 or 1.
  • White blood cell (WBC) count ≥ 3,000/mm3 within 2 weeks prior to registration.
  • Platelet count ≥ 100,000/mm3 within 2 weeks prior to registration.
  • Serum glutamic-oxaloacetic transaminase (SGOT) ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks prior to registration.
  • Aspartate aminotransferase test (AST) ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks prior to registration.
  • Bilirubin ≤ 2 x institutional upper limit (IUL) of normal obtained within 2 weeks prior to registration.
  • Serum creatinine ≤ 1.8 mg/dl obtained within 2 weeks prior to registration.
  • Must sign an informed consent approved by the University of Arkansas for Medical Sciences (UAMS) Institutional Review Board (IRB).

Exclusion Criteria

  • Active infection requiring treatment with antibiotics.
  • Diagnosis or evidence of organic brain syndrome that might preclude participation in the full protocol.
  • Diagnosis or evidence of significant impairment of basal cognitive function that might preclude participation in the full protocol.
  • No 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.
  • 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 receiving the first dose of study drug 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, Intrauterine Device (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 1/Phase 2
Study Type
Interventional
Allocation
Non-Randomized
Intervention Model
Parallel Assignment
Primary Purpose
Treatment
Masking
None (Open Label)

Arm Groups

ArmDescriptionAssigned Intervention
Active Comparator
Chemovax Schedule A
Chemovax schedule A: Subjects will receive the first cycle of chemotherapy along with the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), second cycle of chemotherapy on week 4, and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
  • Biological: Chemovax
    Timing of the vaccination relative to chemotherapy
    Other names:
    • P10s-PADRE with standard chemotherapy
    • P10s-PADRE with MONTANIDE™ ISA 51 VG
    • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy
Active Comparator
Chemovax Schedule B
Chemovax Schedule B: Subjects will receive the first cycle of chemotherapy on week 1, the first injection of vaccine on week 2, the subsequent two injections of the vaccine one week apart (week 3 and 4), second cycle of chemotherapy on week 4 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22).
  • Biological: Chemovax
    Timing of the vaccination relative to chemotherapy
    Other names:
    • P10s-PADRE with standard chemotherapy
    • P10s-PADRE with MONTANIDE™ ISA 51 VG
    • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy
Active Comparator
Chemovax Schedule C
Chemovax Schedule C: Subjects will receive three weekly injections of vaccine (week 1,2,3), then first cycle of chemotherapy (week 4), and subsequent cycles of chemotherapy every 21 days (week 7,10,13,16,19,22,25).
  • Biological: Chemovax
    Timing of the vaccination relative to chemotherapy
    Other names:
    • P10s-PADRE with standard chemotherapy
    • P10s-PADRE with MONTANIDE™ ISA 51 VG
    • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy
Active Comparator
Chemovax Schedule D
Chemovax Schedule D: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 2 (along with second vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 5,8,11,14,17,20,23).
  • Biological: Chemovax
    Timing of the vaccination relative to chemotherapy
    Other names:
    • P10s-PADRE with standard chemotherapy
    • P10s-PADRE with MONTANIDE™ ISA 51 VG
    • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy
Active Comparator
Chemovax Schedule E
Chemovax Schedule E: Subjects will receive the first injection of vaccine on week 1, the subsequent two injections of the vaccine one week apart (week 2 and 3), the first cycle of chemotherapy on week 3 (along with third vaccine injection) and subsequent cycles of chemotherapy every 21 days (week 6,9,12,15,18,21,24).
  • Biological: Chemovax
    Timing of the vaccination relative to chemotherapy
    Other names:
    • P10s-PADRE with standard chemotherapy
    • P10s-PADRE with MONTANIDE™ ISA 51 VG
    • P10s-PADRE/ MONTANIDE™ ISA 51 VG with standard chemotherapy

Recruiting Locations

More Details

NCT ID
NCT02229084
Status
Enrolling by invitation
Sponsor
University of Arkansas

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.