Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
Completed · Phase 2
Conditions studied: Breast Cancer
In brief
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 settings access to appropriate cancer care is characteristically limited or often plainly nonexistent. In contrast to economically developed nations, where on average fewer than 20% of women present with breast cancer at advanced stages, LABC and metastatic disease are the most common stages at presentation in 50% or more women in Latin America, Asia and Africa.
Key facts
- Study ID
- NCT02280252
- Run by
- NYU Langone Health
- People needed
- 69
- Starts
- 2005-03-01
- Expected to finish
- 2018-12-20
- Last updated by the study team
- 2020-11-23
Who can join
Age: 18 and older. Sex: female. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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)
Where it is running
- NYU Langone Medical Center — New York, New York, United States
Full record on ClinicalTrials.gov
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