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Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients

Information source: Ohio State University Comprehensive Cancer Center
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Breast Cancer

Intervention: Trastuzumab (Drug); Bevacizumab (Drug); Docetaxel (Drug)

Phase: Phase 2

Status: Active, not recruiting

Sponsored by: Bhuvaneswari Ramaswamy

Official(s) and/or principal investigator(s):
Charles L Shapiro, MD, Principal Investigator, Affiliation: Ohio State University

Summary

The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.

Clinical Details

Official title: Phase II Trial of Trastuzumab (Herceptin), Bevacizumab, and Docetaxel (Taxotere) Trial in Stage IV Metastatic Breast Cancer (MBC) Patients

Study design: Endpoint Classification: Safety Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Primary outcome: The primary objectives are to determine the progression-free survival (PFS) and to evaluate safety of the trastuzumab, bevacizumab and docetaxel regimen.

Secondary outcome:

Changes in CTCs and CECs as predictors of PFS and clinical benefit

Overall clinical benefit rate (CR+PR+SD)

Detailed description: Rationale: Antibodies are proteins that are normally part of the immune system that bind to foreign agents in the body. Researchers manufacture antibodies outside of the human body that bind to specific targets such as proteins in cancer cells. Herceptin is a monoclonal antibody that binds to the human epidermal growth factor receptor (HER-2), and can kill HER2-positive cancer cells. Herceptin is used to treat breast cancer that is HER2-positive, and has spread after treatment with other drugs. Bevacizumab is a signal transduction inhibitor that works by preventing the growth of new blood vessels from surrounding tissue into tumors. Bevacizumab specifically inhibits the vascular endothelial growth factor (VEGF), a substance made by cells that stimulates new blood vessel formation. Research indicates that HER-2 signaling helps to induce VEGF expression. Therefore, cancer treatments targeting both HER-2 and VEGF may improve anti-cancer efficacy in patients. Docetaxel is a chemotherapy agent used against breast and other types of cancer. The current study builds on previous research suggesting the safety and potential for efficacy with combination trastuzumab, bevacizumab, and docetaxel. Purpose: The primary objectives are to determine the progression free survival and evaluate the safety of trastuzumab, bevacizumab, and docetaxel. Secondary objectives are to assess early changes in circulating tumor cells and circulating endothelial cells as predictors of progression free survival and clinical benefit, as well as to determine the overall clinical benefit rate. Treatment: Study participants will be given trastuzumab, bevacizumab, and docetaxel. All study drugs will be given through intravenous infusions once every 21 days. A cycle is considered 3 weeks. A minimum of 6 study treatment cycles is required unless study participants experience disease growth or intolerable toxicity. The decision to stop docetaxel after 6 cycles is up to the discretion of the treating physician and the patient. Study participants who are deriving a benefit from the study drugs may continue on trastuzumab and bevacizumab alone. Several tests and exams will be given throughout the study to closely monitor study participants.

Eligibility

Minimum age: 18 Years. Maximum age: N/A. Gender(s): Both.

Criteria:

Inclusion Criteria:

- Histologically confirmed breast cancer with evidence of metastatic disease

- HER2 3+ or FISH +

- Age ≥ 18 years

- No prior trastuzumab, except as given in the adjuvant or neoadjuvant setting.

- No prior chemotherapy in the metastatic setting.

Exclusion Criteria:

- CNS metastases

- Prior radiation therapy within the last 4 weeks

- Pregnant (positive pregnancy test) or lactating women

- Major surgical procedure, open biopsy, non-healing wounds, or significant traumatic

injury within 28 days prior to starting study or anticipation of need for major surgical procedure during the study

- Minor surgical procedures such as fine needle aspirations or core biopsies within 7

days prior to start of study.

Locations and Contacts

Cleveland Clinic Foundation, Cleveland, Ohio 44195, United States

Ohio State University, Columbus, Ohio 43210, United States

University of Pittsburgh, Pittsburgh, Pennsylvania 15213, United States

Additional Information

Jamesline

Starting date: June 2007
Last updated: August 19, 2015

Page last updated: August 23, 2015

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