Clinical trial

Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer

NCT00048893 · National Cancer Institute (NCI), NIH · Terminated

Key facts

NCT number NCT00048893
Title Vaccine and Chemotherapy for Previously Untreated Metastatic Breast Cancer
Official title A Multicenter Phase I-II Study of Tumor Vaccine Following Chemotherapy in Patients With Metastatic Breast Cancer Untreated With Chemo/Radiation in the Previous 18 Months: Vaccine-Induced Bias of T-Cell Repertoire Reconstitution After T-Cell Re-Infusion
Lead sponsor National Cancer Institute (NCI), NIH
Status Terminated
Phase Phase 1/Phase 2
Study type Interventional
Conditions Breast Neoplasms, Metastases, Neoplasm
Intervention type Biological, Drug
Interventions recombinant fowlpox-CEA(6D)/TRICOM vaccine, recombinant vaccinia-CEA(6D)/TRICOM vaccine, filgrastim, sargramostim, cyclophosphamide, doxorubicin hydrochloride, fludarabine phosphate, paclitaxel, Mesna
Enrollment 37
Start date Nov 1, 2002
Primary completion Jun 1, 2011
Completion Jun 1, 2011
First posted Nov 11, 2002
Last update posted Apr 13, 2012
Countries United States

At a glance

  • 1–9 Study sites
  • Yes Results posted
  • None Linked FDA submissions

Counts are shown as ranges. Exact figures, trends and every underlying record are available in Orca1.

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Source: U.S. National Library of Medicine (NLM), ClinicalTrials.gov · Source date:

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