Vaccination of Triple Negative Breast Cancer Patients

  • End date
    Nov 8, 2024
  • participants needed
  • sponsor
    University of Arkansas
Updated on 26 February 2022
breast cancer
triple negative breast cancer


The purpose of this study is to evaluate a new investigational cancer vaccine, P10s-PADRE in combination with standard neoadjuvant chemotherapy and surgery in patients with clinical stage I, II or III triple negative breast cancer (TNBC). This study will compare the vaccine plus standard neoadjuvant chemotherapy and surgery to standard neoadjuvant chemotherapy and surgery alone.


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.

Condition Triple Negative Breast Cancer, Breast Neoplasms
Treatment Standard chemotherapy, P10s-PADRE with MONTANIDE™ ISA 51 VG, P10s-PADRE with MONTANIDE™ ISA 51 VG + Doxorubicin + Cyclophosphamide + Paclitaxel, Doxorubicin + Cyclophosphamide + Paclitaxel
Clinical Study IdentifierNCT02938442
SponsorUniversity of Arkansas
Last Modified on26 February 2022


Yes No Not Sure

Inclusion Criteria

Females of all races with biopsy-proven clinical stage I, II, or III TNBC (ER-negative, PR-negative and HER2-negative) who will undergo SoC 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) or aspartate aminotransferase test (AST) 2 x 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 glutamic-pyruvic transaminase (SGPT) or alanine aminotransferase test (ALT) 2 x 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 IRB

Exclusion Criteria

Active infection requiring treatment with antibiotics
ER-positive, PR-positive, HER2-positive, inflammatory, metastatic, stage IV or recurrent breast cancer
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
Active autoimmune disorders or conditions of immunosuppression; Existing diagnosis or history of autoimmune disorders or conditions of immunosuppression that have been in remission for less than 6 months
Treatment with corticosteroids, including oral steroids (i.e. prednisone, dexamethasone [except when used as an antiemetic in SoC 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 breastfeeding (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
Enrollment in any other clinical trial using investigational drug products or devices prior to first post-surgery study lab (Week 46 visit). Concurrent enrollment in observational studies is allowed
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