Phase 2
N=69
Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
Breast Cancer
Bottom Line
View on ClinicalTrials.gov: NCT02280252 ↗Enrolled (actual)
69
Serious AEs
—
Results posted
Nov 2020
Primary outcome: Primary: Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- Paclitaxel (Drug); Radiation therapy (Radiation)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- NYU Langone Health
- Primary completion
- Dec 2018
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort |
— | — |
| SECONDARY Measure the Pathological Response Rate of Concurrent Paclitaxel-radiation |
— | — |
| SECONDARY Perform Molecular Biology and Genomic Studies of Obtained Core Biopsies to Identify Biomarkers for Predisposition to Breast Cancer |
— | — |
| SECONDARY Patient Demographics |
— | — |
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.
Eligibility 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)
Data sourced from ClinicalTrials.gov (NCT02280252). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.