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

NCT02280252 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 69

Last updated 2020-11-23

Study results available
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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.

Conditions

Interventions

DRUG

Paclitaxel

Paclitaxel (including Abraxane), 30 mg/m2 twice per week. Paclitaxel will be given IV over 1 hour, Abraxane® will be administered over 30 min, and administered on a Monday/Thursday or Tuesday/Friday schedule.

RADIATION

Radiation therapy

Patients will receive a total dose of 45 Gy to the breast, axilla and supraclavicular area at 1.8 Gy/fraction, +14 Gy to the original palpable tumor at 2 Gy/fraction (total 32 fractions)

Sponsors & Collaborators

Principal Investigators

  • Nelly Huppert, M.D. · NYU Langone Medical Center

Study Design

Allocation
NA
Purpose
TREATMENT
Masking
NONE
Model
SINGLE_GROUP

Eligibility

Min Age
18 Years
Sex
FEMALE
Healthy Volunteers
No

Timeline & Regulatory

Start
2005-03-31
Primary Completion
2018-12-20
Completion
2018-12-20
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs
Diseases
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02280252 on ClinicalTrials.gov