Alternate Title
Basic Trial Information
Objectives
Entry Criteria
Expected Enrollment
Outcomes
Outline
Trial Contact Information
Registry Information

Alternate Title

Vaccine Therapy in Treating Patients With Breast Cancer

Basic Trial Information

Phase	Type	Status	Age	Sponsor	Protocol IDs
Phase II	Treatment	Active	Over 18	Other	WRAMC-07-20029 07-20029, WRAMC-9625-1186753655.52, NCT00524277

Objectives

1. To determine if the GP2 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-positive, HER2/neu-positive, node-positive, or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, sargramostim (GM-CSF), alone.
2. To determine if the AE37 peptide/GM-CSF vaccine reduces the recurrence rate in HLA-A2-negative, HER2/neu-positive, node-positive or high-risk node-negative breast cancer patients randomized to receive the vaccine versus the immunoadjuvant, GM-CSF, alone.
3. To monitor the in vitro and in vivo immunologic responses to the vaccines and correlate these responses with the clinical outcomes.
4. To monitor for any unexpected toxicities with the vaccines.

Entry Criteria

Disease Characteristics:

Inclusion criteria:

• Meets one of the following criteria:
  • Lymph node-positive breast cancer
  • High-risk lymph node-negative breast cancer, defined by any one of the following criteria:
    • T2 disease
    • Grade 3 disease
    • Lymphovascular invasion
    • Estrogen receptor- or progesterone receptor-negative disease
    • N0 (I+) disease



• HER2/neu-expressing tumor (immunohistochemistry [IHC] 1-3+ and/or positive fluorescence in situ hybridization [FISH] > 1.2)



• Clinically cancer-free (no evidence of disease) after completion (between 1-6 months ago) 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)

Exclusion criteria:

• HER2/neu-negative breast cancers (IHC 0)



• Clinical and/or radiographic evidence of residual or persistent breast cancer

Prior/Concurrent Therapy:

Inclusion criteria:

• See Disease Characteristics

Exclusion criteria:

• Concurrent immunosuppressive therapy including chemotherapy, steroids, or methotrexate
• Concurrent participation in another experimental treatment (except with permission of the other study investigator)

Patient Characteristics:

Inclusion criteria:

• Female or male
• Menopausal status not specified
• Immunologically intact by recall anergy testing
• Negative pregnancy test

Exclusion criteria:

• Anergic by the Mantoux panel of recall antigens
• 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
• Breastfeeding
• History of autoimmune disease

Expected Enrollment

Outcomes

Disease recurrence

Safety
Toxicity

Outline

This is a multicenter study. Patients are stratified according to nodal status. Patients are randomized to 1 of 2 treatment arms.

• Arm I: HLA-A2-positive patients receive GP2 peptide/GM-CSF vaccine intradermally (ID) every 3-4 weeks for a total of up to 6 inoculations. HLA-A2-negative patients receive AE37 peptide/GM-CSF vaccine ID every 3-4 weeks for a total of up to 6 inoculations.



• Arm II : Patients receive GM-CSF ID every 3-4 weeks for a total of up to 6 inoculations.

After completion of study therapy, patients are followed every 3 months for the first 24 months and then every 6 months for an additional 36 months.

Trial Contact Information

Trial Lead Organizations

Walter Reed Army Medical Center

George Peoples, MD, Protocol chair		Ph: 210-916-1117

U.S.A.
District of Columbia
	Washington
	Sibley Memorial Hospital
		Sheila Evans, RN, MS, AOCN	Ph:  202-243-2320
			Email: sevans@sibley.org
	Walter Reed Army Medical Center
		Diane Papay, RN	Ph:  202-782-3877
Hawaii
	Honolulu
	Tripler Army Medical Center
		Jane Doll, RN	Ph:  808-433-2857
North Carolina
	Winston-Salem
	Wake Forest University Comprehensive Cancer Center
		Robin Petro, RN	Ph:  336-713-4788
			Email: rpetro@wfubmc.edu
Texas
	Dallas
	Mary Crowley Medical Research Center at Sammons Cancer Center
		Clinical Trials Office - Mary Crowley Medical Research Center at Sammons Cancer Center	Ph:  214-370-1877
	Fort Hood
	Carl R. Darnall Army Medical Center
		Edna Figueroa-Dias, RN	Ph:  254-288-8048
	Fort Sam Houston
	Brooke Army Medical Center
		Karen Parsons, BSN, RN	Ph:  210-916-4837
	Houston
	M. D. Anderson Cancer Center at University of Texas
		Clinical Trials Office - M. D. Anderson Cancer Center at the University of Texas	Ph:  713-792-3245
Washington
	Tacoma
	Madigan Army Medical Center - Tacoma
		Shari Aynes, RN, CCRC	Ph:  253-968-3891
Germany
	Landstuhl
	Landstuhl Regional Medical Center
		Mark Carmichael, MD	Ph:  49-6371-86-8100
Greece
	Athens
	Saint Savas Cancer Hospital of Athens
		Michael Papamichail, MD, PhD	Ph:  30-210-6409-624
			Email: papamichail@ciic.gr

Registry Information
Official Title		Prospective, Randomized, Single-Blinded, Multi-Center Phase II Trial of the HER2/neu Peptide GP2 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2+ OR the Modified HER2/neu Peptide AE37 + GM-CSF Vaccine versus GM-CSF Alone in HLA-A2- Node-Positive and High-Risk Node-Negative Breast Cancer Patients to Prevent Recurrence
Trial Start Date		2007-01-24
Registered in ClinicalTrials.gov		NCT00524277
Date Submitted to PDQ		2007-08-13
Information Last Verified		2009-06-15

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