Docetaxel,Carboplatin,Trastuzumab and Bevacizumab for Breast Cancer and Bone Marrow Micrometastases

Early Phase 1

Completed

Interventions: Biological: bevacizumab
Biological: trastuzumab
Drug: carboplatin
Drug: docetaxel
Other: laboratory biomarker analysis

Brief Summary: RATIONALE: Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab and bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving chemotherapy together with monoclonal antibody therapy may kill more tumor cells.

PURPOSE: This clinical trial is studying how well giving docetaxel and carboplatin together with trastuzumab and bevacizumab works in treating patients with stage I, stage II, or stage III breast cancer and bone marrow micrometastases.

Detailed Description: OBJECTIVES:

Primary

* Determine the clinical response in patients with HER2/neu-positive stage I-III breast cancer and bone marrow micrometastases treated with docetaxel, carboplatin, trastuzumab, and bevacizumab.

Secondary

* Investigate the specific contribution of VEGF and CXCL-12 (SDF-1) signaling to bone marrow support of HER2/neu-positive breast cancer cells.

* Evaluate growth factor and chemokine expression profiles to investigate the potential correlation of expression with patient outcome and frequency of tumor cell clusters (mammospheres with tumor stem cell phenotype) in microenvironment supported cultures.

OUTLINE: Patients receive docetaxel IV, carboplatin IV, and bevacizumab IV over 30-90 minutes on day 1 and trastuzumab IV over 30-90 minutes on days 1, 8, and 15. Treatment repeats every 21 days for 6 courses in the absence of disease progression or unacceptable toxicity. After 6 courses, treatment modifications may apply according to response.

Tumor tissue and bone marrow samples may be collected for further laboratory analysis.

After completion of study therapy, patients are followed up for 30 days.

Recruitment & Eligibility

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Arm && Interventions

Group	Intervention	Description
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab	laboratory biomarker analysis	-
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab	bevacizumab	-
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab	trastuzumab	-
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab	carboplatin	-
Docetaxel,Carboplatin,Trastuzumab and Bevacizumab	docetaxel	-

Primary Outcome Measures

Name	Time	Method
Proportion of patients who have a complete response in bone marrow.	at 4 weeks after completing 6 courses of therapy

Secondary Outcome Measures

Name	Time	Method
Specific contribution of VEGF and CXCL-12 (SDF-1) signaling to bone marrow support of HER2/neu-positive breast cancer cells	pre- and post-treatment
Potential correlation of growth factor and chemokine expression with patient outcome and frequency of tumor cell clusters (mammospheres with tumor stem cell phenotype) in microenvironment supported cultures	pre- and post-therapy

Locations (5): Cleveland Clinic Taussig Cancer Institute, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States
Case Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center
🇺🇸
Cleveland, Ohio, United States
University Hospitals Monarch
🇺🇸
Mayfield Heights, Ohio, United States
University Hospitals Westlake
🇺🇸
Westlake, Ohio, United States
University Hospitals Chagrin Highlands Medical Center
🇺🇸
Orange Village, Ohio, United States