Vaccine Therapy Plus Sargramostim and Chemotherapy in Treating Women With Stage II or Stage III Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00052351
Recruitment Status : Completed
First Posted : January 27, 2003
Last Update Posted : June 19, 2013
Information provided by:
National Cancer Institute (NCI)

Brief Summary:

RATIONALE: Vaccines made from a gene-modified virus may make the body build an immune response to kill tumor cells. Colony-stimulating factors such as sargramostim may increase the number of immune cells found in bone marrow or peripheral blood. Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining vaccine therapy with sargramostim and chemotherapy may kill more tumor cells.

PURPOSE: Randomized clinical trial to study the effectiveness of vaccine therapy plus sargramostim and combination chemotherapy in treating women who have undergone surgery for stage II or stage III breast cancer that has spread to the lymph nodes.

Condition or disease Intervention/treatment Phase
Breast Cancer Biological: recombinant fowlpox-CEA(6D)/TRICOM vaccine Biological: recombinant vaccinia-CEA(6D)-TRICOM vaccine Biological: sargramostim Drug: cyclophosphamide Drug: doxorubicin hydrochloride Drug: paclitaxel Radiation: radiation therapy Phase 2

Detailed Description:


  • Compare the immunological effects of 2 different schedules of vaccinia-CEA-TRICOM vaccine, fowlpox-CEA-TRICOM vaccine, and sargramostim (GM-CSF) administered with standard adjuvant chemotherapy in women with high-risk stage II or III breast cancer.
  • Compare the safety of these regimens in these patients.
  • Determine the feasibility of obtaining determinations of CD4 response in patients treated with these regimens.
  • Compare disease-free survival of patients treated with these regimens.

OUTLINE: This is a randomized study. Patients are randomized to 1 of 2 treatment arms.

  • Vaccinia-CEA-TRICOM: Beginning 2-3 weeks after surgery and before initiation of standard adjuvant chemotherapy, all patients receive vaccinia-CEA-TRICOM vaccine subcutaneously (SC) on day 1 and sargramostim (GM-CSF) SC on days 1-4 of week 1.
  • Fowlpox-CEA-TRICOM: Patients are treated on 1 of the following schedules:

    • Arm I: During chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of weeks 2, 5, 8, 11, 14, 17, 20, and 23. After chemotherapy, patients receive additional vaccinations on weeks 26, 38, and 50.
    • Arm II: Prior to chemotherapy, patients receive fowlpox-CEA-TRICOM vaccine SC on day 1 and GM-CSF SC on days 1-4 of week 2. After chemotherapy, patients receive additional vaccinations on weeks 26, 38, and 50.
  • Chemotherapy: Patients receive doxorubicin IV over 5-7 minutes and cyclophosphamide IV over 30 minutes on day 1 of weeks 3, 6, 9, and 12. Patients then receive paclitaxel IV over 3 hours on day 1 of weeks 15, 18, 21, and 24. Treatment continues in the absence of disease progression (after at least 1 course of chemotherapy) or unacceptable toxicity.
  • Radiotherapy: Patients undergo radiotherapy during weeks 26-32 in the absence of disease progression.

Patients with hormone-receptor positive tumors receive oral tamoxifen for 5 years beginning on approximately week 32.

Patients are followed every 6 months for 5 years.

PROJECTED ACCRUAL: A total of 28 (14 per treatment arm) patients will be accrued for this study within 18 months.

Study Type : Interventional  (Clinical Trial)
Allocation: Randomized
Primary Purpose: Treatment
Official Title: A Pilot Study Of Sequential Vaccinations With Recombinant Vaccinia-CEA(6D)-TRICOM, And Recombinant Fowlpox-CEA(6D)-TRICOM (B7.1/ICIAM-1/LFA-3) With Sargramostim (GM-CSF), In Conjunction With Standard Adjuvant Chemotherapy In High Risk Breast Cancer Patients Status Post Surgery With 4+ Or More Lymph Nodes And CEA Expressing Tumors
Study Start Date : September 2002
Actual Study Completion Date : October 2007

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.

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


  • Histologically confirmed adenocarcinoma of the breast

    • Stage II or III
    • At least 4 positive lymph nodes
    • No inflammatory ductal carcinoma
  • No positive lymph nodes by immunohistochemistry only
  • Carcinoembryonic antigen (CEA) expression, as indicated by 1 of the following:

    • At least 30% of tumor stains for CEA on immunohistochemistry
    • Elevated serum CEA (greater than 5 ng/mL) anytime during disease course
  • Must be HLA-A2 positive
  • Must have received prior vaccinia for smallpox immunization with 1 of the following as evidence:

    • If age 25 and under, physician certification of prior vaccination
    • If over age 25, patient recollection and vaccination-site scar
    • Any age, detectable anti-vaccinia antibodies
  • No metastases by CT scan of chest, abdomen, and pelvis and a bone scan
  • Hormone receptor status:

    • Estrogen receptor status and progesterone receptor status known



  • 18 and over


  • Female

Menopausal status:

  • Not specified

Performance status

  • ECOG 0-1

Life expectancy

  • Not specified


  • WBC at least 3,000/mm^3
  • Absolute neutrophil count at least 1,500/mm^3
  • Platelet count at least 100,000/mm^3


  • Bilirubin no greater than 1.5 times upper limit of normal (ULN)
  • SGOT and SGPT no greater than 1.5 times ULN
  • Hepatitis B and C negative


  • Creatinine no greater than 1.5 mg/dL OR
  • Creatinine clearance greater than 60 mL/min
  • No proteinuria OR
  • Protein less than 1,000 mg per 24-hour urine collection
  • No hematuria
  • No abnormal sediment


  • LVEF at least 45% by echocardiogram or MUGA if either of the following are true:

    • History of cardiac disease
    • Received prior cardiotoxic chemotherapy


  • No evidence of immunocompromised status
  • No autoimmune disease such as any of the following:

    • Autoimmune neutropenia, thrombocytopenia, or hemolytic anemia
    • Systemic lupus erythematosus
    • Sjogren's syndrome
    • Scleroderma
    • Myasthenia gravis
    • Goodpasture syndrome
    • Addison's disease
    • Hashimoto's thyroiditis
    • Active Graves' disease
  • No active or prior eczema or other eczematoid skin disorders
  • No other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
  • HIV negative
  • No active infection within the past 3 days
  • No allergy to eggs
  • No history of allergy or untoward reaction to prior vaccination with vaccinia virus


  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception
  • No other serious illness
  • No other malignancy within the past 3 years except squamous cell or basal cell skin cancer
  • No history of seizures, encephalitis, or multiple sclerosis
  • No active inflammatory bowel disease
  • Must be able to avoid close household contact with the following during and for 2 weeks after vaccinations:

    • Persons with active or prior eczema or other eczematoid skin disorders
    • Persons with any other acute, chronic, or exfoliative skin conditions (e.g., atopic dermatitis, burns, impetigo, varicella zoster, severe acne, or other open rashes or wounds)
    • Pregnant or nursing women
    • Children under 5 years old
    • Immunodeficient or immunosuppressed persons (by disease or therapy), including those with HIV infection


Biologic therapy

  • See Disease Characteristics


  • No prior doxorubicin, cyclophosphamide, or paclitaxel

Endocrine therapy

  • No concurrent steroids except the following:

    • Topical steroids
    • Inhaled steroids for moderate asthma
    • Dexamethasone prior to taxanes


  • No prior radiotherapy to more than 50% of the lymph nodes


  • At least 2 weeks since prior surgery and recovered
  • No prior splenectomy


  • No other concurrent anti-tumor therapies

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 identifier (NCT number): NCT00052351

United States, Maryland
Warren Grant Magnuson Clinical Center - NCI Clinical Studies Support
Bethesda, Maryland, United States, 20892-1182
Center for Cancer Research
Bethesda, Maryland, United States, 20892
Sponsors and Collaborators
National Cancer Institute (NCI)
Study Chair: Philip M. Arlen, MD National Cancer Institute (NCI) Identifier: NCT00052351     History of Changes
Obsolete Identifiers: NCT00047398
Other Study ID Numbers: CDR0000258196
First Posted: January 27, 2003    Key Record Dates
Last Update Posted: June 19, 2013
Last Verified: May 2003

Keywords provided by National Cancer Institute (NCI):
stage II breast cancer
stage IIIA breast cancer
stage IIIB breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Liposomal doxorubicin
Immunologic Factors
Physiological Effects of Drugs
Immunosuppressive Agents
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors
Anti-Infective Agents
Antiprotozoal Agents
Antiparasitic Agents