Vaccine Therapy in Treating Patients With Breast Cancer

Completed · Phase 2

Conditions studied: Breast Cancer

In brief

RATIONALE: Vaccines made from peptides may help the body build an effective immune response to kill tumor cells that express HER2/neu. Biological therapies, such as GM-CSF, may stimulate the immune system in different ways and stop tumor cells from growing. It is not yet known whether vaccine therapy is more effective than GM-CSF in treating breast cancer. PURPOSE: This randomized phase II trial is studying vaccine therapy to see how well it works compared with GM-CSF in treating patients with breast cancer.

Key facts

Study ID: NCT00524277
Run by: San Antonio Military Medical Center
People needed: 456
Starts: 2007-01-01
Expected to finish: 2017-03-31
Last updated by the study team: 2020-03-30

Who can join

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

You may qualify if…

Lymph node-positive breast cancer or high-risk lymph node-negative breast cancer. The latter is defined by any one of the following criteria:
T2 disease
Grade 3 disease
Lymphovascular invasion
Estrogen receptor- or progesterone receptor-negative disease
HER2/neu-expressing tumor (immunohistochemistry [IHC] 3+ and/or amplified fluorescence in situ hybridization [FISH] >2.2, or N0 (i+))
HER2/neu-expressing tumor (IHC 1-3+ and or positive FISH >1.2)
Completion of primary standard of care breast cancer therapies (i.e., surgery, chemotherapy, immunotherapy and radiation therapy as appropriate per standard of care for patients' specific cancer)
Clinically cancer-free (no evidence of disease)
Patients may be enrolled between 1-6 months from completion of standard primary breast cancer therapies
Good performance status (as defined in Exclusion Criteria)
Capable of informed consent

You may not qualify if…

HER2/neu-negative breast cancers (IHC 0)
Clinical and/or radiographic evidence of residual or persistent breast cancer
Receiving immunosuppressive therapy to include chemotherapy, steroids, or methotrexate
In poor health (Karnofsky <60%, ECOG >/-2)
Total bilirubin >1.8, creatinine >2, hemoglobin <10, platelets <50,000, WBC <2,000)
Active interstitial lung disease; asthma requiring more than as needed bronchodilators for management; or other autoimmune lung disease
Pregnancy (urine hCG)
Breast feeding
History of autoimmune disease
Involved in other experimental protocols (except with permission of the other study PI)
PATIENT CHARACTERISTICS:
Inclusion criteria:
Female or male
Menopausal status not specified
Immunologically intact by recall anergy testing
Negative pregnancy test
Exclusion criteria:
Karnofsky 0-60% or ECOG ≥ 2
Total bilirubin > 1.8 g/dL
Creatinine > 2.0 g/dL
Hemoglobin < 10.0 g/dL
Platelet count < 50,000/mm³
WBC< 2,000/mm³
Active pulmonary disease requiring medication that includes multiple inhalers
Pregnancy

Where it is running

Sibley Memorial Hospital — Washington D.C., District of Columbia, United States
University of Hawaii Cancer Center — Honolulu, Hawaii, United States
MedStar Union Memorial Hospital — Baltimore, Maryland, United States
MedStar Good Samaritan Hospital Cancer Center — Baltimore, Maryland, United States
Walter Reed National Military Medical Center — Bethesda, Maryland, United States
Wake Forest University Comprehensive Cancer Center — Winston-Salem, North Carolina, United States
Carl R. Darnall Army Medical Center — Fort Hood, Texas, United States
San Antonio Army Medical Center — Fort Sam Houston, Texas, United States
University of Texas MD Anderson Cancer Center — Houston, Texas, United States
STOH Clinical Research — San Antonio, Texas, United States
Madigan Army Medical Center - Tacoma — Tacoma, Washington, United States
Landstuhl Regional Medical Center — Landstuhl, Kirchberg, Germany
Saint Savas Cancer Hospital of Athens — Athens, Greece

Full record on ClinicalTrials.gov

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