Trial Outcomes & Findings for Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response (NCT NCT03096418)
NCT ID: NCT03096418
Last Updated: 2026-01-16
Results Overview
To test if high cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria
Recruitment status
RECRUITING
Study phase
PHASE4
Target enrollment
50 participants
Primary outcome timeframe
Up to 3 months
Results posted on
2026-01-16
Participant Flow
Participant milestones
| Measure |
Weekly Paclitaxel
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|
|
Overall Study
STARTED
|
24
|
|
Overall Study
Paclitaxel Concentration Determine
|
15
|
|
Overall Study
Analyzed After First Dose
|
16
|
|
Overall Study
Analyzed After Third Dose
|
5
|
|
Overall Study
Analyzed After Twelfth Dose
|
1
|
|
Overall Study
COMPLETED
|
24
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Weekly Paclitaxel and Biomarkers of Therapy Response
Baseline characteristics by cohort
| Measure |
Weekly Paclitaxel
n=24 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|
|
Age, Customized
20-29 years
|
1 Participants
n=9 Participants
|
|
Age, Customized
30-39 years
|
4 Participants
n=9 Participants
|
|
Age, Customized
40-49 years
|
7 Participants
n=9 Participants
|
|
Age, Customized
50-59 years
|
7 Participants
n=9 Participants
|
|
Age, Customized
60-69 years
|
2 Participants
n=9 Participants
|
|
Age, Customized
70-79 years
|
3 Participants
n=9 Participants
|
|
Sex: Female, Male
Female
|
24 Participants
n=9 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
0 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
24 Participants
n=9 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Black or African American
|
2 Participants
n=9 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=9 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=9 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=9 Participants
|
|
Region of Enrollment
United States
|
24 participants
n=9 Participants
|
PRIMARY outcome
Timeframe: Up to 3 monthsPopulation: Only 12 participants were evaluable because of insufficient specimen.
To test if high cancers with high chromosomal instability (CIN) respond to paclitaxel better than low CIN cancers. Response determined by the percent decrease in linear measurement of tumor size on the greatest dimension per RECIST-like criteria
Outcome measures
| Measure |
Weekly Paclitaxel
n=12 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Response to Paclitaxel
|
-29.63 percent decrease in tumor size
Interval -70.21 to 30.0
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 dayPopulation: Participant 10 withdrew consent.
Identify patient-specific differences in tumor levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.
Outcome measures
| Measure |
Weekly Paclitaxel
n=14 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Tumor Level Difference of Paclitaxel
Participant 5
|
NA micromolar
Insufficient tumor tissue collected by biopsy
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 12
|
NA micromolar
Insufficient tumor tissue collected by biopsy
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 1
|
1.07 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 2
|
0.34 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 3
|
0.80 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 4
|
0.57 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 6
|
3.43 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 7
|
1.55 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 8
|
0.53 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 9
|
0.63 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 11
|
0.57 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 13
|
1.67 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 14
|
0.52 micromolar
|
—
|
—
|
—
|
|
Tumor Level Difference of Paclitaxel
Participant 15
|
1.20 micromolar
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 1 dayPopulation: Participant 10 withdrew consent
Identify patient-specific differences in non-tumor (plasma) levels of paclitaxel at 20 hours after first dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing variability between patients with descriptive statistics.
Outcome measures
| Measure |
Weekly Paclitaxel
n=14 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Non-Tumor Level Difference of Paclitaxel
Participant 1
|
0.023 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 2
|
0.040 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 3
|
0.030 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 4
|
0.027 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 5
|
0.031 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 6
|
0.020 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 7
|
0.013 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 8
|
0.011 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 9
|
0.020 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 11
|
0.038 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 12
|
0.040 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 13
|
0.094 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 14
|
0.048 micromolar
|
—
|
—
|
—
|
|
Non-Tumor Level Difference of Paclitaxel
Participant 15
|
0.035 micromolar
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 79 daysPaclitaxel levels at the first dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by high-performance liquid chromatography of tumor and plasma samples and comparing difference at two time points within the same patient with paired statistics.
Outcome measures
| Measure |
Weekly Paclitaxel
n=7 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Paclitaxel Levels
First dose plasma paclitaxel
|
0.041 micromolars
Interval 0.014 to 0.094
|
—
|
—
|
—
|
|
Paclitaxel Levels
Third dose plasma paclitaxel
|
0.029 micromolars
Interval 0.013 to 0.062
|
—
|
—
|
—
|
|
Paclitaxel Levels
First dose intratumoral paclitaxel
|
0.785 micromolars
Interval 0.34 to 1.67
|
—
|
—
|
—
|
|
Paclitaxel Levels
Third dose intratumoral paclitaxel
|
1.21 micromolars
Interval 0.12 to 2.4
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 79 daysPopulation: An increasing smaller subset of participants were biopsied after the first dose.
Compare pre-existing versus post-treatment antimitotic effects at 20 hours after the 1st dose, 20 hours after the 3rd dose, and 20 hours after the 12th dose. This is measured by tissue analysis of tumor samples with phospho-histone H3 and stains for spindle morphology to quantify mitotic index and mitotic characteristics at two time points using paired statistical analysis.
Outcome measures
| Measure |
Weekly Paclitaxel
n=16 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
n=16 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
n=5 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
n=1 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Antimitotic Effects
Participant 1
|
113 number of mitotic cells
|
109 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 2
|
41 number of mitotic cells
|
100 number of mitotic cells
|
32 number of mitotic cells
|
—
|
|
Antimitotic Effects
Participant 3
|
100 number of mitotic cells
|
104 number of mitotic cells
|
105 number of mitotic cells
|
—
|
|
Antimitotic Effects
Participant 4
|
101 number of mitotic cells
|
103 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 6
|
106 number of mitotic cells
|
108 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 7
|
79 number of mitotic cells
|
103 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 8
|
75 number of mitotic cells
|
27 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 9
|
35 number of mitotic cells
|
63 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 11
|
6 number of mitotic cells
|
11 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 12
|
24 number of mitotic cells
|
30 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 13
|
106 number of mitotic cells
|
110 number of mitotic cells
|
101 number of mitotic cells
|
—
|
|
Antimitotic Effects
Participant 14
|
86 number of mitotic cells
|
102 number of mitotic cells
|
20 number of mitotic cells
|
—
|
|
Antimitotic Effects
Participant 15
|
116 number of mitotic cells
|
101 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 16
|
106 number of mitotic cells
|
104 number of mitotic cells
|
—
|
—
|
|
Antimitotic Effects
Participant 18
|
42 number of mitotic cells
|
214 number of mitotic cells
|
23 number of mitotic cells
|
8 number of mitotic cells
|
|
Antimitotic Effects
Participant 19
|
30 number of mitotic cells
|
70 number of mitotic cells
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 20 hours post-first dosePopulation: Clinical Response reported here.
The mitotic index is a measure of cells arresting in mitosis, previously thought to be the major mechanism of taxol action. It is defined as the percentage of cells undergoing mitosis in a given population of cells. An elevated mitotic index indicates more cells are at this phase of the cell cycle at the time of sampling.
Outcome measures
| Measure |
Weekly Paclitaxel
n=13 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
n=13 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Mitotic Index
Participant 1
|
1.4 mitotic index
|
2.6 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 2
|
1 mitotic index
|
3.379722 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 3
|
1.35 mitotic index
|
4.4 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 4
|
1.8 mitotic index
|
3.192745 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 6
|
1.052765 mitotic index
|
2.305837 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 7
|
1.2 mitotic index
|
3.201638 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 8
|
0.6 mitotic index
|
1.29731 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 9
|
1.466667 mitotic index
|
1.872558 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 11
|
0.198311 mitotic index
|
0.32 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 12
|
0.32 mitotic index
|
1.44 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 13
|
2 mitotic index
|
4.2 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 14
|
1.48 mitotic index
|
2.87 mitotic index
|
—
|
—
|
|
Mitotic Index
Participant 15
|
1.33 mitotic index
|
5.56 mitotic index
|
—
|
—
|
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This biomarker was not measured
Correlate pathologic response and clinical response with biomarkers including aneuploidy
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: This was not measured
Correlate pathologic response and clinical response with biomarkers including CIN
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 3 monthsPopulation: Clinical Response reported here.
The Ki-67 protein is a cellular marker for proliferation. Ki-67 is an excellent marker to determine the growth fraction of a given cell population. The fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) is often correlated with the clinical course of cancer.
Outcome measures
| Measure |
Weekly Paclitaxel
n=12 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Ki67 of Tumor
Participant 1
|
90 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 2
|
80 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 3
|
90 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 6
|
45 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 7
|
90 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 8
|
60 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 9
|
15 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 11
|
20 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 12
|
25 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 13
|
90 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 14
|
60 Percentage of Ki67 + cells
|
—
|
—
|
—
|
|
Ki67 of Tumor
Participant 15
|
60 Percentage of Ki67 + cells
|
—
|
—
|
—
|
SECONDARY outcome
Timeframe: Baseline and 20 hours post-first dosePopulation: Insufficient tissue was collected to complete analysis on remaining participants
There are many proposed ways to measure CIN. Here, we used # of multipolar spindles as a surrogate of CIN measures.
Outcome measures
| Measure |
Weekly Paclitaxel
n=13 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After First Dose
n=13 Participants
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Third Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
Weekly Paclitaxel - 20 Hours After Twelfth Dose
Paclitaxel 80 mg/m2 will be initiated as standard infusion on days 1, 8, 15 of a 21-day cycle.
Participants will continue with paclitaxel 80 mg/m2 for cycles 2-4 prior to surgery.
Paclitaxel: Paclitaxel is an FDA approved medication for treatment of curable breast cancer and is available by prescription at pharmacies throughout the United States.
|
|---|---|---|---|---|
|
Change in CIN Levels
Participant 4
|
3.96039604 % of cells with multipolar spindles
|
29.12621359 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 6
|
16.98113208 % of cells with multipolar spindles
|
60.18518519 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 7
|
3.797468354 % of cells with multipolar spindles
|
64.0776699 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 8
|
5.33333333 % of cells with multipolar spindles
|
62.96296296 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 9
|
8.571428571 % of cells with multipolar spindles
|
61.9047619 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 11
|
0 % of cells with multipolar spindles
|
27.27 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 12
|
4.2 % of cells with multipolar spindles
|
56.6 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 13
|
5.6 % of cells with multipolar spindles
|
64.5 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 14
|
13.95 % of cells with multipolar spindles
|
58.82 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 15
|
3.45 % of cells with multipolar spindles
|
60.4 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 3
|
2.44 % of cells with multipolar spindles
|
26.92 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 1
|
7.08 % of cells with multipolar spindles
|
51.38 % of cells with multipolar spindles
|
—
|
—
|
|
Change in CIN Levels
Participant 2
|
2.44 % of cells with multipolar spindles
|
49 % of cells with multipolar spindles
|
—
|
—
|
Adverse Events
Weekly Paclitaxel
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Cancer Connect
University of Wisconsin Carbone Cancer Center
Phone: 800-622-8922
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place