Status:
COMPLETED
Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
Lead Sponsor:
NYU Langone Health
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
The need to understand LABC is especially compelling in populations and countries with limited resources, where breast cancer incidence is relatively low, but mortality is comparably high. In these se...
Detailed Description
The term -locally advanced breast cancer (LABC) commonly includes tumors whose maximum diameter is 5 cm (T3) or larger, or which present with involvement of the chest wall or skin. Surprisingly, the s...
Eligibility Criteria
Inclusion
- Biopsy proven locally-advanced breast cancer: IIB, IIIA, and IIIB
- Metastatic breast cancer: limited to the subset of patients with intact breast, locally advanced tumor and involved ipsilateral supraclavicular nodes
- Measureable disease required
- Adequate laboratory values:
- Hgb \> 10 ANC \> 1500 Platelets \> 150,000 Creatinine \< 1.5 Liver function \< 3x normal
- Patient ≥ 18 years of age
- Medically and psychologically able to comply with all study requirements
- ECOG performance score 0-1
- CT chest, abdomen, and pelvis performed
- Mammogram or USG performed
- Signed informed consent
Exclusion
- Breast cancer patients with Stage 0, Stage I, or Stage IIA
- Previous XRT or chemotherapy
- Presence of distant metastases documented clinically or radiographically with the exception of ipsilateral supraclavicular nodes
- Pregnancy
- Inflammatory breast cancer
- Patients under treatment (or who will have recently been treated) with anti-neoplastic, immunosuppressive or hormonal medications
- Patients who are found to have a cancer positive for the marker HER-2/neu (applies only to NYU Tisch and Bellevue sites)
Key Trial Info
Start Date :
March 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 20 2018
Estimated Enrollment :
69 Patients enrolled
Trial Details
Trial ID
NCT02280252
Start Date
March 1 2005
End Date
December 20 2018
Last Update
November 23 2020
Active Locations (1)
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1
NYU Langone Medical Center
New York, New York, United States, 10016