Study of Cancer Peptides Vaccine Plus GM-CSF as Adjuvant Treatment for High Risk (TXN2-3M0) or Metastatic Breast Cancer With No Evidence of Disease

A Phase I Study of Cancer Peptides Plus GM-CSF and Adjuvant (Montanide ISA 51) Following Completion of Prescribed Chemotherapy or Trastuzumab for TXN2-3M0 or Metastatic Breast Cancer With No Evidence of Disease

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00674791

Enrollment

Registered

2008-05-08

Start date

2007-06-30

Completion date

2010-01-31

Last updated

2013-06-19

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Keywords

Immunotherapeutic vaccine, breast cancer, TxN2-3M0 breast cancer, metastatic breast cancer, immunotherapy, antigen, Histologically confirmed, TxN2-3M0 or metastatic breast cancer

Brief summary

This study will evaluate the safety and feasibility of administering a peptide vaccine consisting of twelve different tumor-rejection antigens to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy. The vaccine is designed to elicit immune responses against twelve different pathways that are essential to tumor growth, survival and metastasis.

Detailed description

The primary endpoint will be to determine the safety and feasibility of administering cancer peptides to patients with high risk (TxN2-3M0) or metastatic breast cancer with no evidence of disease following their completion of systemic therapy, with the secondary objectives of evaluating immune response disease relapse survival. Two cohorts of 9 patients each will be treated with different doses of the vaccine. They will receive the peptide vaccine subcutaneously on weeks 0,1,2,4,5, and 6 and then receive the immunizations every 1 month for 6 months or disease recurrence. Toxicity will be assessed at each dose level using CTCv3 toxicity criteria.

Interventions

BIOLOGICALOCPM Immunotherapeutic Vaccine

Patients will receive 1 injection into each thigh at each of 6 visits: week 0, week 1, week 2, week 4, week 5, and week 6. The first 9 patients will receive a 100 microgram dose and the second 9 patients a 1 milligram dose of the peptide mixture.

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

* HLA-A2 patients with histologically confirmed, TxN2-3M0 or metastatic breast cancer with no evidence of disease who have completed their adjuvant systemic chemotherapy or trastuzumab * Subjects will not be treated until 4 or more weeks after any prior chemotherapy, radiation therapy or immunotherapy, but they may be receiving hormonal therapy

Exclusion criteria

* History of autoimmune disease * Serious intercurrent chronic or acute illness * Active hepatitis * Serologic evidence for HIV, splenectomy * Receiving steroid or immunosuppressive therapy

Design outcomes

Primary

Measure	Time frame
Safety/tolerability: Number of subjects with dose limiting toxicity after 3 immunizations.	Status post-3 immunizations

Secondary

Measure	Time frame
Immunologic response: Number of subjects with tumor antigen specific immune response after 3 immunizations.	Status post-3 immunizations

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026