Trial Outcomes & Findings for Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer (NCT NCT00088829)

Results Overview

Due to the early termination of the study, this data for this outcome was not collected.

Recruitment status

TERMINATED

Study phase

PHASE2

Target enrollment

22 participants

Primary outcome timeframe

3 months

Results posted on

2018-07-11

Participant milestones
Measure	Paclitaxel Paclitaxel given before surgery paclitaxel: subjects will receive paclitaxel neoadjuvantly microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis biopsy: All subjects will have a biopsy to collect tissue neoadjuvant therapy: paclitaxel is given neoadjuvantly Paclitaxel: All patients will receive paclitaxel neoadjuvantly
Overall Study STARTED	22
Overall Study COMPLETED	0
Overall Study NOT COMPLETED	22

Reasons for withdrawal
Measure	Paclitaxel Paclitaxel given before surgery paclitaxel: subjects will receive paclitaxel neoadjuvantly microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis biopsy: All subjects will have a biopsy to collect tissue neoadjuvant therapy: paclitaxel is given neoadjuvantly Paclitaxel: All patients will receive paclitaxel neoadjuvantly
Overall Study PI left institution and study was close	22

Genetic Testing in Predicting Response to Paclitaxel in Women With Breast Cancer

Baseline characteristics by cohort
Measure	Paclitaxel n=22 Participants Paclitaxel given before surgery paclitaxel: subjects will receive paclitaxel neoadjuvantly microarray analysis: subjects will have a biopsy to collect tissue for gene microarray analysis biopsy: All subjects will have a biopsy to collect tissue neoadjuvant therapy: paclitaxel is given neoadjuvantly Paclitaxel: All patients will receive paclitaxel neoadjuvantly
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	12 Participants n=5 Participants
Age, Categorical >=65 years	10 Participants n=5 Participants
Sex: Female, Male Female	22 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	22 participants n=5 Participants

Timeframe: 3 months

Due to the early termination of the study, this data for this outcome was not collected.

Outcome data not reported

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Adverse event data not reported

Adverse event data not reported

Georgetown University Medical Center

Phone: 202-444-3677