Adenovirus Encoding Rat HER-2 in Patients With Metastatic Breast Cancer (AdHER2.1)

A Phase I Trial Investigating the Safety and Immunogenicity of an Adenovirus Encoding Rat HER-2 Administered Intradermally to Patients With Metastatic or Locally Recurrent Breast Cancer

Status

Completed

Phases

Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00307229

Enrollment

Registered

2006-03-27

Start date

2006-03-31

Completion date

2012-05-31

Last updated

2012-06-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Metastatic Breast Cancer, Recurrent Breast Cancer

Keywords

metastatic breast cancer, recurrent breast cancer

Brief summary

To determine the maximum tolerated dose and/or maximum attainable dose of a vaccine consisting of adenovector expressing rat Her-2/neu in patients with metastatic or locally recurrent breast cancer.

Interventions

BIOLOGICALadenoviral vector encoding rat Her-2/neu

Group 1 1 x 10'7 pfu (2.5 X 10'6 pfu per injection site)(1.6 x 10'9 particles) Group 2 5 x 10'7 pfu (1.25 X 10'7 pfu per injection site)(8.0 x10'9 particles) Group 3 1 x 10'8 pfu (5 x 10'7 pfu per injection site)(1.6 x10'10 particles)

Study design

Allocation

NON_RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. metastatic or locally recurrent breast cancer, 2. 18 years of age or older, 3. Her-2/neu positive (3+ by immunohistochemistry or FISH +), 4. One of the following 1. currently receiving hormonal therapy or are candidates for such or, 2. being considered for trastuzumab or, 3. their cancer has progressed on trastuzumab

Exclusion criteria

1. Pregnant or lactating women. 2. Prior or concurrent malignancies except treated basal cell or squamous carcinoma of the skin or in situ cancer of the cervix or any other cancer treated and presumed cured more than five years prior to study entry. 3. Currently receiving chemotherapy, immunotherapy, adenoviral gene therapy or biological cancer therapy. \[Note: concurrent hormonal therapy (tamoxifen,aromatase inhibitors, or megace) is permitted.\]. 4. Treatment with trastuzumab within 4 weeks prior to first dose of vaccine therapy. 5. Hemoglobin \< 80 g/L or granulocytes \< 1.5 x 109 /L or lymphocytes \< 1.0 x 109 /L or platelets \< 100 x 109 /L. 6. Baseline liver enzymes (AST or ALT) greater than 3 times upper limit of normal or greater than 5 times upper limit of normal if liver metastases present and/or bilirubin greater than 50 mmol. 7. CD4 cells \< 0.5 x 109 /L 8. Patients with documented brain metastases. 9. Patients with any acute illness that would interfere with vaccination 10. Any patients requiring concurrent immunosuppressive therapy (e.g. corticosteroids). 11. Eastern Cooperative Oncology Group (ECOG) performance status of \> 2. 12. Patients with a life expectancy of less than 6 months. 13. Geographic inaccessibility which would preclude follow-up. Patients registered on the trial must be treated and followed at the Jewish General Hospital. 14. Failure to give written informed consent. 15. Baseline left ventricular ejection fraction (LVEF) \< 55% by echocardiography or MUGA scan.

Design outcomes

Primary

Measure	Time frame
toxicity	Weeks 4, 6, 7, 10, 14, 18, 22, 26

Secondary

Measure	Time frame
tumour response	Weeks 6, 18

Countries

Canada

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026