Status:
TERMINATED
Locally Advanced Breast Cancer: Individualized Treatment Based On Tumor Molecular Characteristics
Lead Sponsor:
NYU Langone Health
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-90 years
Phase:
PHASE1
PHASE2
Brief Summary
Paclitaxel 30 mg/m2 twice/week Trastuzumab 4mg/kg, loading dose, then 2 mg/kg weekly and Concurrent RT (to start within one week from first dose of Paclitaxel/Trastuzumab) to breast, supraclavicular, ...
Detailed Description
Locally Advanced Breast Cancer: T greater than 3.0 cm. HER-2/neu positive. Patients with ipsilateral supraclavicular nodes are eligible. Patients with inflammatory breast cancer or distant metastases ...
Eligibility Criteria
Inclusion
- Biopsy proven locally advanced breast cancer: STAGE IIB (T must be \> 3.0 cm, N0), IIIA (T0N2, T1N2, T2N2, T3N1), IIIB (T4N0-2).
- HER-2/neu positive ( DAKO 3+ by Immunohistochemistry or FISH positive if Dako 2+)
- Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes.
- Measurable disease required according to the RECIST criteria (Response Evaluation Criteria in Solid Tumors)
- Adequate laboratory values:
- Hgb \> 10
- ANC(Absolute Neutrophil Count) \> 1500
- Platelets \> 150,000
- Cr \< 1.5
- Liver function \< 3 X normal.
- Patient \> 18 years of age.
- Medically and psychologically able to comply with all study requirements.
- ECOG (Eastern cooperative Oncology group) performance score 0-1.
- Signed informed consent.
Exclusion
- Stage 0, Stage I, Stage IIA.
- Previous XRT(Radiation therapy) or chemotherapy.
- Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes.
- Inflammatory breast cancer.
- Prior unanticipated severe reaction to fluoropyrimidine therapy or known hypersensitivity to 5-fluorouracil.
- Exclude pregnant or lactating woman.
- Woman of childbearing potential with either a positive or no pregnancy test at baseline.
- Woman of childbearing potential not using a reliable and appropriate contraceptive method.
- (Postmenopausal women must have been amenorrheic for at least 12 months to be considered of non-childbearing potential).
- Patient will agree to continue contraception for 30 days from the date of the last study drug administration.
- Serious concurrent infections.
- Clinically significant cardiac disease not well controlled with medication (e.g. congestive heart failure, symptomatic coronary artery disease and cardiac arrhythmias ) or myocardial infarction within the last 12 months.
- Patients who have had an organ allograft.
- Patients with severe renal impairment (creatinine clearance below 30 mL/min \[Cockcroft and Gault43\]). In patients with moderate renal impairment (creatinine clearance 30-50 mL/min \[Cockcroft and Gault43\]) at baseline, a dose reduction to 75% of the XELODA starting dose is recommended. In patients with mild renal impairment (creatinine clearance 51-80 mL/min) no adjustment in starting dose is recommended.
- In phase I studies, those with any abnormal renal function, since toxicity will likely be affected by the presence of any significant renal dysfunction.
- Cockcroft and Gault Equation:
- (140 - age \[yrs\]) (body wt \[kg\])
- Creatinine clearance for males = --------------
- (72) (serum creatinine \[mg/dL\])
- Creatinine clearance for females = 0.85 x male value
Key Trial Info
Start Date :
June 1 2002
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 2 2014
Estimated Enrollment :
44 Patients enrolled
Trial Details
Trial ID
NCT02297230
Start Date
June 1 2002
End Date
December 2 2014
Last Update
October 15 2018
Active Locations (1)
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1
Weill Medical College of Cornell University
New York, New York, United States, 10065