Clinical trial · Interventional
Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
Response, Resistance and Metastasis of Locally Advanced Breast Cancer (LABC, Stage 2B-3C) in a Multiethnic Cohort: A Phase II International Multicentric Study of Concurrent Paclitaxel and Radiation
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Paclitaxel | Drug | Paclitaxel | ALIAS |
| Radiation therapy | Radiation | — | UNRESOLVED |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Concurrent Paclitaxel and RT
- description
- Patients will be administered pre-operatively over 12 weeks either: 1. Paclitaxel, 30mg/m\^2 twice per week, intravenously over 1 hour on a Monday/Thursday or Tuesday/Friday schedule 2. Abraxane, 30mg/m\^2 twice per week, intravenously administered over 30 minutes, on a Monday/Thursday or Tuesday/Friday schedule Patients will concurrently receive 6 weeks of radiation therapy, weeks 2-7: Patients will receive a total dose to the breast, axilla and supraclavicular area of 45 Gy at 1.8 Gy/fraction, +14 Gy to the area of the original palpable tumor at 2 Gy/fraction (32 fractions)
- interventionNames
- Drug: Paclitaxel
- Radiation: Radiation therapy
Primary outcomes (1)
- measure
- Test the Clinical Effectiveness of Concurrent Paclitaxel and Radiation in a Multiethnic Cohort
- timeFrame
- 4.5 years
- description
- Test the effectiveness of concurrent paclitaxel and radiation in a prospective multiethnic cohort of patients with newly diagnosed stage 2B-3C breast cancer treated at three international academic centers under uniform conditions. Local recurrence, regional recurrence and overall survival will be measured
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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)
References
Publications (0)
Data not yet available