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

Completed · Phase 1

Conditions studied: Breast Cancer

In brief

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.

Key facts

Study ID

NCT00674791

Run by

Duke University

People needed

13

Starts

2007-06-01

Expected to finish

2010-01-01

Last updated by the study team

2013-06-19

Who can join

Age: 18 and older. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

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

Where it is running

• Duke Comprehensive Cancer Center — Durham, North Carolina, United States

Full record on ClinicalTrials.gov

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