CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 69 enrolled
Drug / intervention
Paclitaxel +1 moredrug
Likely dose
Paclitaxel 30 mg/m2from record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02280252
NCT02280252Phase 2Completed

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

NYU Langone Health·interventional·Posted Oct 31, 2014·Updated Nov 23, 2020

In Brief

A Phase 2 clinical trial evaluating Paclitaxel and Radiation therapy for Breast Cancer. Completed, enrolled 69 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedOct 31, 2014
Enrollment StartMar 1, 2005
Primary CompletionDec 20, 2018
TodayJul 2, 2026
Enrollment to primary: 13.8 yearsPosted 11.7 years ago

Interventions

Paclitaxeldrug

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 therapyradiation

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)