Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response

• Status: Completed
• Trial end date: 2018-12-20
• Target enrollment: 0
• Participant gender: Female

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 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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: New York University School of Medicine; NYU Langone Health
• Treatments: Albumin-Bound Paclitaxel; Paclitaxel

Criteria

Inclusion Criteria:

• 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 Criteria:

• 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)