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Vaccination of Triple Negative Breast Cancer Patients

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ClinicalTrials.gov Identifier: NCT02938442
Recruitment Status : Recruiting
First Posted : October 19, 2016
Last Update Posted : February 6, 2019
Sponsor:
Information provided by (Responsible Party):
University of Arkansas

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Biological: P10s-PADRE with MONTANIDE™ ISA 51 VG Drug: Standard Chemotherapy Phase 2

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 102 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
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
Actual Study Start Date : January 24, 2019
Estimated Primary Completion Date : November 2020
Estimated Study Completion Date : November 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Standard Chemotherapy
The first or "control" arm will receive standard chemotherapy for triple negative breast cancer.
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 Name: Chemovax

Drug: Standard Chemotherapy
Standard chemotherapy only




Primary Outcome Measures :
  1. rate of pCR in breast and axillary lymph nodes [ Time Frame: at the time of definitive surgery ]


Information from the National Library of Medicine

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

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 ClinicalTrials.gov identifier (NCT number): NCT02938442


Contacts
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Contact: Issam Makhoul, MD 5016868274 makhoulissam@uams.edu
Contact: Sandy Annis 5016868274 amannis@uams.edu

Locations
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United States, Arkansas
Highlands Oncology Group Recruiting
Fayetteville, Arkansas, United States, 72703
Contact: J T Beck, MD         
Contact    479-587-1700      
Principal Investigator: J T Beck, MD         
University of Arkansas for Medical Sciences Recruiting
Little Rock, Arkansas, United States, 72205
Contact: Sandy Annis       amannis@uams.edu   
Principal Investigator: Issam Makhoul, MD         
Sponsors and Collaborators
University of Arkansas
Investigators
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Principal Investigator: Issam Makhoul, MD University of Arkansas

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Responsible Party: University of Arkansas
ClinicalTrials.gov Identifier: NCT02938442     History of Changes
Other Study ID Numbers: 206010
206010 ( Other Identifier: UAMS Institutional Review Board )
First Posted: October 19, 2016    Key Record Dates
Last Update Posted: February 6, 2019
Last Verified: February 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

Additional relevant MeSH terms:
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Triple Negative Breast Neoplasms
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Vaccines
Freund's Adjuvant
Immunologic Factors
Physiological Effects of Drugs
Adjuvants, Immunologic