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Vaccine Therapy in Preventing Recurrence in Patients with Her-2 Positive Stage I-III Breast Cancer

Status
Closed
Cancer Type
Breast Cancer
Trial Phase
Phase II
Eligibility
18 Years and older, Male and Female
Study Type
Treatment
NCT ID
NCT03384914
Protocol IDs
MCC-19117 (primary)
NCI-2018-00290
Study Sponsor
Moffitt Cancer Center

Summary

This phase II trial studies the side effects and how well vaccine therapy works in preventing recurrence (return of breast cancer) in patients with HER-2 positive stage I-III breast cancer. Vaccines work by boosting the immune system (a system in our bodies that protects us against infection) to recognize and destroy the cancer causing cell proteins.

Objectives

PRIMARY OBJECTIVES:
I. To evaluate safety and tolerability of each vaccine therapy.
II. To evaluate the immunogenicity following each vaccine therapy.

SECONDARY OBJECTIVE:
I. To determine disease free survival (DFS) of patients with HER2 positive breast cancer after treatment with each vaccine.

OUTLINE: Patients are randomized to 1 of 2 arms.

ARM I: Patients receive HER2-pulsed autologous type-1 polarized dendritic cell vaccine (DC1) intranodally weekly in weeks 1-6. Patients receive booster vaccines at 6, 9, and 12 months.

ARM II: Patients receive pUMVC3-IGFBP2-HER2-IGF1R plasmid DNA vaccine (WOKVAC) intradermally in weeks 1, 4, and 7. Patients receive booster vaccines at 6, 9. and 12 months.

After completion of study treatment, patients are followed up every 6 months for up to 2 years.

Eligibility

  1. Clinical stage I-III HER-2 positive breast cancer treated with neoadjuvant chemotherapy including HER-2 directed treatment for at least 12 weeks
  2. Residual invasive carcinoma in the breast or axillary nodes in the final pathology from resected tumor following neoadjuvant chemotherapy
  3. Completed last cycle of cytotoxic chemotherapy (excluding ado-trastuzumab emtansine [T-DM1]) or radiation > 30 days with resolution of all acute toxic effects of prior therapy to grade =< 2 (except alopecia)
  4. Currently on HER-2 targeted therapy (e.g. trastuzumab +/- pertuzumab or per standard of care) or has completed HER-2 targeted therapy less than 6 months from registration
  5. Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
  6. Absolute neutrophil count (ANC) >= 1,000/ uL
  7. Platelets >= 75,000/ uL
  8. Total bilirubin =< 1.5 x institutional upper limit of normal (ULN), except patients with Gilbert’s syndrome in whom total bilirubin must be < 3.0 mg/dL
  9. Aspartate aminotransferase (AST)/alanine aminotransferase (ALT) =< 3 x institutional upper limit of normal (ULN)
  10. Creatinine =< 1.5 x institutional upper limit of normal (ULN)
  11. Hemoglobin A1C < 6.5%
  12. Left ventricular ejection fraction (LVEF) above institutional lower limit of normal (by echocardiogram or multi-gated acquisition [MUGA] scan within 90 days of registration)
  13. Female patients of child-bearing potential must agree to use dual methods of contraception and have a negative serum pregnancy test at screening, and male patients must use an effective barrier method of contraception if sexually active with a female of child-bearing potential; acceptable methods of contraception are condoms with contraceptive foam, oral, implantable or injectable contraceptives, contraceptive patch, intrauterine device, diaphragm with spermicidal gel, or a sexual partner who is surgically sterilized or post-menopausal; for both male and female patients, effective methods of contraception must be used throughout the study and for three months following the last dose; to be considered of non-childbearing potential, postmenopausal women must be amenorrheic for at least 12 months naturally (not in the setting of post chemotherapy) or patients must be surgically sterile
  14. Ability to understand and willingness to sign a written informed consent document prior to initiation of any screening or study-specific procedures

Treatment Sites in Georgia

Winship Cancer Institute of Emory University


1365 Clifton Road NE
Building C
Atlanta, GA 30322
404-778-5180
winshipcancer.emory.edu

**Clinical trials are research studies that involve people. These studies test new ways to prevent, detect, diagnose, or treat diseases. People who take part in cancer clinical trials have an opportunity to contribute to scientists’ knowledge about cancer and to help in the development of improved cancer treatments. They also receive state-of-the-art care from cancer experts... Click here to learn more about clinical trials.
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Advancing Cancer Care through Partnerships and Innovation

Georgia CORE is a statewide nonprofit that leverages partnerships and innovation to attract more clinical trials, increase research, and promote education and early detection to improve cancer care for Georgians in rural, urban, and suburban communities across the state.