Status:
UNKNOWN
Study of Neoadjuvant Chemotherapy of Breast Cancer
Lead Sponsor:
Auxilio Mutuo Cancer Center
Collaborating Sponsors:
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
19+ years
Phase:
PHASE2
Brief Summary
The purpose of this study is to evaluate the pathological CR rate in breast and lymph nodes of a novel neoadjuvant regimen for invasive breast carcinoma.
Detailed Description
Neoadjuvant chemotherapy has been used for years to treat patients with breast cancer whose primary tumors are too large to allow for breast conservation surgery \[1\]. Reduction in size of the primar...
Eligibility Criteria
Inclusion
- Previously untreated (no chemotherapy or hormonal therapy or radiation therapy) invasive breast cancer.
- Diagnosis of invasive ductal or lobular breast cancer plus or minus DCIS. Inflammatory carcinomas will also be eligible.
- Age \> 18 years
- Tumor \> 1.0 cm by MRI and/or sonographic or clinical exam measurements.Although only tumors \> 2 cm are considered measurable by RECIST criteria, we will nevertheless include tumors \> 1 cm since the primary endpoint is pathological CR rate.
- Performance Status ECOG \<2 or Karnofsky \>50%
- Peripheral neuropathy \< grade 1
- Hematologic (minimal values):
- Absolute neutrophil count \> 1,500/mm3
- Hemoglobin \> 8.0 g/dl
- Platelet count \> 100,000/mm3
- Hepatic
- Total Bilirubin normal
- AST and ALT and Alkaline Phosphatase do not have to be within the range. In determining eligibility the more abnormal of the two values (AST or ALT) should be used as shown below.
Exclusion
- Pregnant or breast feeding patients are excluded.
- Patients with second malignancies with expected survival \< 5 years.
- Previous chemotherapy with either Taxanes, Anthracyclines or Cyclophosphamide.
- Patients with history of severe hypersensitivity reaction to Taxotere (Docetaxel) or other drugs formulated with polysorbate 80.
- Pure DCIS diagnoses are not eligible.
- Special histologies with favorable prognosis such as mucinous, tubular are not eligible.
- Patients with reduced ejection fraction \<50% are not eligible.
- Patients with tumors \< 1.0 cm
- Cardiac thrombotic events in the past 12 months
- Stroke or transient ischemic attacks (TIA) within 12 months
- Poorly controlled hypertension defined as persistent blood pressure elevation \>150 systolic and/or 100 diastolic not responsive to medications
- GI condition that increases risk of perforation within 6 months of study
- Any serious non-healing wound, ulcer, or bone fracture
- No minor surgical procedure within 7 day of study entry or major surgery within 28 days of study entry or anticipation of need for major surgical procedure during the course of the study
- Significant vascular disease such as symptomatic peripheral vascular disease
- Any evidence of bleeding diathesis or coagulopathy
Key Trial Info
Start Date :
July 1 2008
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2012
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT00830544
Start Date
July 1 2008
End Date
December 1 2012
Last Update
July 13 2012
Active Locations (1)
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1
Auxilio Mutuo Cancer Center
San Juan, Puerto Rico, 00927