Trial Outcomes & Findings for Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response (NCT NCT02280252)
NCT ID: NCT02280252
Last Updated: 2020-11-23
Results Overview
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
COMPLETED
PHASE2
69 participants
4.5 years
2020-11-23
Participant Flow
The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Participant milestones
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Concurrent Paclitaxel and RT
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)
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 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)
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Overall Study
STARTED
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Overall Study
COMPLETED
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Overall Study
NOT COMPLETED
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Study of Concurrent Paclitaxel and Radiation: Correlation of Tumor Profiles With Pathologic Response
Baseline characteristics by cohort
Baseline data not reported
PRIMARY outcome
Timeframe: 4.5 yearsPopulation: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
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
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4.5 yearsPopulation: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Measure the pathological response rate to concurrent paclitaxel-radiation at each collaborating institution and compare it to that achieved in a previous Phase I-II trial
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4.5 yearsPopulation: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Obtain core biopsies of the original tumor before and after treatment (from the surgical specimen) for molecular biology and genomic studies of biomarkers and genetic anomalies that may signal a population's predisposition to breast cancer and/or susceptibility to study intervention
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 4.5 yearsPopulation: The PI and study team has left the institution. Efforts were made to contact the PI/study team members, but were unsuccessful. No study data are available
Acquire descriptive information on patient epidemiological, cultural and behavioral characteristics
Outcome measures
Outcome data not reported
Adverse Events
Concurrent Paclitaxel and RT
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place