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Investigator(s):
James L. Gulley, M.D., Ph.D., F.A.C.P. Principal Investigator Phone: 301-435-2956 gulleyj@mail.nih.gov
Referral Contact(s):
Laura D. Otten, R.N., B.S.N., O.C.N. Medical Oncology Referral Coordinator Phone: 301-451-1228 1-866-611-6310 (Toll Free) Fax: 301-451-5433 ottenl@mail.nih.gov	Mary Pazdur, C.R.N.P. Nurse Practitioner Phone: 301-496-7870 Fax: 301-480-5094 pazdurm@mail.nih.gov

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Primary Eligibility:

• Histologically confirmed metastatic adenocarcinoma of the breast
• Measurable disease or evaluable disease
• HER2/neu status known; must have progressive or recurrent disease after prior Herceptin if disease is HER2/neu-positive
• No clinically active brain metastasis
• Estrogen-receptor (ER) status known; must have failed prior primary hormonal treatment if tumor is ER-positive
• No prior docetaxel for metastatic disease
• No inflammatory bowel disease
• No history of allergy or hypersensitivity reaction to eggs or egg products
• No history of active eczema or other acute, chronic, or exfoliative skin conditions
• No history of splenectomy
• Able to avoid close personal contact for 2 weeks after vaccinia vaccination with individuals with a history of active eczema or other acute, chronic, or exfoliative skin conditions, pregnant or nursing women, children < 3 years of age, and immunodeficient or immunosuppressed individuals

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Study Outline:

Patients are randomized to 1 of 2 treatment arms:

Arm I

• Patients receive docetaxel IV over 30 minutes once weekly in weeks 1-3, 5-7, and 9-11
• Vaccinia PANVAC vaccine on week -2 and Fowlpox-PANVAC vaccine SC on Day 1 and monthly
• Sargramostim (GM-CSF) SC once daily for 4 days with each vaccination
• Patients with no disease progression after week 12 continue to receive docetaxel once weekly for 3 weeks followed by 1 week of rest and Fowlpox-PANVAC vaccine plus GM-CSF every 4 weeks until disease progression

Arm II

• Patients receive docetaxel as in Arm I
• Patients with disease progression after week 12 have the option of receiving PANVAC vaccines

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Additional Information:

• This trial will be conducted at the NIH Clinical Center in Bethesda, MD. It is open to patients who meet the eligibility requirements, regardless of where they live in the United States.
• There is no charge for medical care received at NIH Clinical Center.
• FAQs about this study - provides information for patients about the trial such as frequency and duration of visits, costs, how to enroll, treatment plan.
• PDQ (Physicians Data Query) - provides additional details about this study for health care providers.

Reviewed: 9/8/09
Updated: 7/28/08