Trial Outcomes & Findings for Multicentre Study to Determine the Feasibility of Using an Integrated Consent Model to Compare Three Standard of Care Regimens for The Treatment of Triple-Negative Breast Cancer in the Neoadjuvant/Adjuvant Setting (REaCT-TNBC) (NCT NCT02688803)
NCT ID: NCT02688803
Last Updated: 2025-12-04
Results Overview
Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC compared to the number of participants who after being approached subsequently agree to randomization.
Recruitment status
TERMINATED
Study phase
PHASE4
Target enrollment
2 participants
Primary outcome timeframe
One year
Results posted on
2025-12-04
Participant Flow
2 patients were approached for the study between August 30, 2016 and January 31, 2017, and both were enrolled and randomized. The study was closed to accrual prematurely on February 8, 2017, because it did not meet the pilot feasibility endpoints. According to the protocol, feasibility success is defined as over 50% of appropriate patients approached agree to participate, and over 50% of physicians who agree to participate approached patients for the study.
Participant milestones
| Measure |
Dose Dense AC-P
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
|
Dose Dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
|
FEC-D
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
|
|---|---|---|---|
|
Overall Study
STARTED
|
1
|
0
|
1
|
|
Overall Study
COMPLETED
|
1
|
0
|
1
|
|
Overall Study
NOT COMPLETED
|
0
|
0
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Age was not collected. This was a feasibility study.
Baseline characteristics by cohort
| Measure |
Dose Dense AC-P
n=1 Participants
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
|
Dose Dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
|
FEC-D
n=1 Participants
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
|
Total
n=2 Participants
Total of all reporting groups
|
|---|---|---|---|---|
|
Sex: Female, Male
Female
|
—
|
—
|
—
|
0 Participants
Sex variable was not collected. This was a feasibility study.
|
|
Sex: Female, Male
Male
|
—
|
—
|
—
|
0 Participants
Sex variable was not collected. This was a feasibility study.
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
Region of Enrollment
Canada
|
1 participants
n=1 Participants
|
—
|
1 participants
n=1 Participants
|
2 participants
n=2 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.
Percentage of patients who receive chemotherapy in the neoadjuvant/adjuvant setting for TNBC compared to the number of participants who after being approached subsequently agree to randomization.
Outcome measures
| Measure |
Dose Dense AC-P
n=1 Participants
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
|
Dose Dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
|
FEC-D
n=1 Participants
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
|
|---|---|---|---|
|
Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC
Received chemotherapy
|
1 Participants
|
—
|
1 Participants
|
|
Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC
Chemotherapy dose adjustments or delays
|
0 Participants
|
—
|
1 Participants
|
|
Percentage of Patients Who Receive Chemotherapy in the Neoadjuvant/Adjuvant Setting for TNBC
Completed study as planned
|
0 Participants
|
—
|
1 Participants
|
PRIMARY outcome
Timeframe: One yearPopulation: No participants were randomized to the Dose-dense AC group.
Participant satisfaction survey. Overall participant satisfaction will be determined using the participant survey
Outcome measures
| Measure |
Dose Dense AC-P
n=1 Participants
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
|
Dose Dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
|
FEC-D
n=1 Participants
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
|
|---|---|---|---|
|
Participant Satisfaction
The clinical trial was explained clearly to me by my oncologist. · Strongly disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
The clinical trial was explained clearly to me by my oncologist. · Disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
The clinical trial was explained clearly to me by my oncologist. · Neutral
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
The clinical trial was explained clearly to me by my oncologist. · Agree
|
1 Participants
|
—
|
1 Participants
|
|
Participant Satisfaction
The clinical trial was explained clearly to me by my oncologist. · Strongly agree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
The clinical trial was explained clearly to me by my oncologist. · Not applicable
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I thought that the questions I had about the clinical trial were answered to my satisfaction. · Strongly disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I thought that the questions I had about the clinical trial were answered to my satisfaction. · Disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I thought that the questions I had about the clinical trial were answered to my satisfaction. · Neutral
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I thought that the questions I had about the clinical trial were answered to my satisfaction. · Agree
|
1 Participants
|
—
|
1 Participants
|
|
Participant Satisfaction
I thought that the questions I had about the clinical trial were answered to my satisfaction. · Strongly agree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I thought that the questions I had about the clinical trial were answered to my satisfaction. · Not applicable
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
If I was asked to participate in this study again, I would say yes. · Strongly disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
If I was asked to participate in this study again, I would say yes. · Disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
If I was asked to participate in this study again, I would say yes. · Neutral
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
If I was asked to participate in this study again, I would say yes. · Agree
|
1 Participants
|
—
|
1 Participants
|
|
Participant Satisfaction
If I was asked to participate in this study again, I would say yes. · Strongly agree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
If I was asked to participate in this study again, I would say yes. · Not applicable
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that taking part in this study interfered with my quality of life. · Strongly disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that taking part in this study interfered with my quality of life. · Disagree
|
1 Participants
|
—
|
1 Participants
|
|
Participant Satisfaction
I found that taking part in this study interfered with my quality of life. · Neutral
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that taking part in this study interfered with my quality of life. · Agree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that taking part in this study interfered with my quality of life. · Strongly agree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that taking part in this study interfered with my quality of life. · Not applicable
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that it was time-consuming to take part in this study. · Strongly disagree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that it was time-consuming to take part in this study. · Disagree
|
1 Participants
|
—
|
1 Participants
|
|
Participant Satisfaction
I found that it was time-consuming to take part in this study. · Neutral
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that it was time-consuming to take part in this study. · Agree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that it was time-consuming to take part in this study. · Strongly agree
|
0 Participants
|
—
|
0 Participants
|
|
Participant Satisfaction
I found that it was time-consuming to take part in this study. · Not applicable
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.
Percentage of participants who complete study treatment compared to the percentage who discontinue their treatment while on study (compliance) will be calculated using the sites chemotherapy treatment records and data from New Patient Registration.
Outcome measures
| Measure |
Dose Dense AC-P
n=1 Participants
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
|
Dose Dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
|
FEC-D
n=1 Participants
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
|
|---|---|---|---|
|
Percentage of Participants Who Complete Study Treatment
|
0 Participants
|
0 Participants
|
1 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: There were no participants randomized to the Dose Dense AC group.
The number of participants with adverse effects requiring hospitalization
Outcome measures
| Measure |
Dose Dense AC-P
n=1 Participants
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
|
Dose Dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
|
FEC-D
n=1 Participants
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
|
|---|---|---|---|
|
Hospitalization
|
0 Participants
|
—
|
0 Participants
|
SECONDARY outcome
Timeframe: One yearPopulation: 2 patients were approached for the study and randomized. The study did not meet feasibility and accrual was closed early.
The number of participants with adverse effects requiring treatment delays
Outcome measures
| Measure |
Dose Dense AC-P
n=1 Participants
Dose dense AC-P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
Dose dense AC-P: (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 175 mg/m2 q2weeks x 4 cycles)
|
Dose Dense AC
Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
Dose dense AC: Dose dense AC followed by weekly P (doxorubicin 60 mg/m2 plus cyclophosphamide 600 mg/m2 q2weeks x 4 cycles followed by paclitaxel 80 mg/m2 weekly x 12 cycles)
|
FEC-D
n=1 Participants
FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
FEC-D: FEC-D (5-FU 500 mg/m2 plus epirubicin 100 mg/m2 plus cyclophosphamide 500 mg/m2 q3weeks x 3 cycles followed by docetaxel 100 mg/m2 q3weeks x 3 cycles)
|
|---|---|---|---|
|
Treatment Delays
|
0 Participants
|
0 Participants
|
1 Participants
|
Adverse Events
Dose Dense AC-P
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
Dose Dense AC
Serious events: 0 serious events
Other events: 0 other events
Deaths: 0 deaths
FEC-D
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
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place