Trial Outcomes & Findings for Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer (NCT NCT02413320)
NCT ID: NCT02413320
Last Updated: 2021-05-10
Results Overview
To evaluate the pathological complete response rates with neoadjuvant chemotherapy regimens of carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide X 4 cycles and carboplatin plus docetaxel X 6 cycles in subjects with stage I-III triple-negative breast cancer. Pathological complete response is defined as no evidence of disease in the breast and axilla at the time of pathology review except for DCIS.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
101 participants
Primary outcome timeframe
20 weeks
Results posted on
2021-05-10
Participant Flow
Participant milestones
| Measure |
Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide
Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
|
Carboplatin + Docetaxel
Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
|
|---|---|---|
|
Overall Study
STARTED
|
49
|
52
|
|
Overall Study
COMPLETED
|
48
|
52
|
|
Overall Study
NOT COMPLETED
|
1
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Neoadjuvant Study of Two Platinum Regimens in Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide
n=48 Participants
Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
|
Carboplatin + Docetaxel
n=52 Participants
Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
|
Total
n=100 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
51 years
n=5 Participants
|
54 years
n=7 Participants
|
51 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
48 Participants
n=5 Participants
|
52 Participants
n=7 Participants
|
100 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
0 Participants
n=7 Participants
|
0 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
35 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
71 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
9 Participants
n=5 Participants
|
10 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Asian
|
2 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
3 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
2 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Hispanic
|
1 Participants
n=5 Participants
|
1 Participants
n=7 Participants
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Non-Hispanic
|
47 Participants
n=5 Participants
|
51 Participants
n=7 Participants
|
98 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
48 participants
n=5 Participants
|
52 participants
n=7 Participants
|
100 participants
n=5 Participants
|
|
Lymph node status
Negative
|
34 Participants
n=5 Participants
|
36 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
Lymph node status
Positive
|
14 Participants
n=5 Participants
|
16 Participants
n=7 Participants
|
30 Participants
n=5 Participants
|
|
T stage
T1
|
11 Participants
n=5 Participants
|
8 Participants
n=7 Participants
|
19 Participants
n=5 Participants
|
|
T stage
T2
|
31 Participants
n=5 Participants
|
39 Participants
n=7 Participants
|
70 Participants
n=5 Participants
|
|
T stage
T3-4
|
6 Participants
n=5 Participants
|
5 Participants
n=7 Participants
|
11 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 20 weeksPopulation: Intention-to-treat
To evaluate the pathological complete response rates with neoadjuvant chemotherapy regimens of carboplatin plus paclitaxel x 4 cycles followed by doxorubicin plus cyclophosphamide X 4 cycles and carboplatin plus docetaxel X 6 cycles in subjects with stage I-III triple-negative breast cancer. Pathological complete response is defined as no evidence of disease in the breast and axilla at the time of pathology review except for DCIS.
Outcome measures
| Measure |
Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide
n=48 Participants
Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
|
Carboplatin + Docetaxel
n=52 Participants
Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
|
|---|---|---|
|
Number of Participants With Pathological Complete Response
|
26 Participants
|
28 Participants
|
SECONDARY outcome
Timeframe: 20 weeksPopulation: Patients with residual cancer burden index available
To evaluate minimal residual disease rates (residual cancer burden 0+1) with two neoadjuvant chemotherapy regimens in subjects with stage I-III triple-negative breast cancer.
Outcome measures
| Measure |
Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide
n=46 Participants
Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
|
Carboplatin + Docetaxel
n=52 Participants
Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
|
|---|---|---|
|
Number of Participants With Minimal Residual Disease
|
31 Participants
|
35 Participants
|
Adverse Events
Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide
Serious events: 0 serious events
Other events: 41 other events
Deaths: 0 deaths
Carboplatin + Docetaxel
Serious events: 0 serious events
Other events: 13 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Carboplatin + Paclitaxel Then Doxorubicin + Cyclophosphamide
n=48 participants at risk
Paclitaxel (80mg/m2) given IV every week x12 weeks and Carboplatin (AUC 6) given IV every 21 days x 4 cycles, followed by Doxorubicin (60mg/m2) given IV and Cyclophosphamide (600mg/m2) given IV every 14 days X 4 cycles
|
Carboplatin + Docetaxel
n=52 participants at risk
Carboplatin (AUC 6) given IV and Docetaxel (75mg/m2) given IV every 21 days x 6 cycles
|
|---|---|---|
|
Blood and lymphatic system disorders
Anemia
|
45.8%
22/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
3.8%
2/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Blood and lymphatic system disorders
Neutropenia
|
60.4%
29/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
7.7%
4/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Blood and lymphatic system disorders
Thrombocytopenia
|
16.7%
8/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
3.8%
2/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
18.8%
9/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
0.00%
0/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Investigations
Hypokalemia
|
4.2%
2/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
1.9%
1/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Investigations
Hyponatremia
|
4.2%
2/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
1.9%
1/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Gastrointestinal disorders
Nausea
|
2.1%
1/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
0.00%
0/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Gastrointestinal disorders
Constipation
|
2.1%
1/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
0.00%
0/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Gastrointestinal disorders
Diarrhea
|
2.1%
1/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
7.7%
4/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
General disorders
Fatigue
|
2.1%
1/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
0.00%
0/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
General disorders
Pain
|
2.1%
1/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
1.9%
1/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
4.2%
2/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
0.00%
0/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Skin and subcutaneous tissue disorders
Rash
|
0.00%
0/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
3.8%
2/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
|
Infections and infestations
Infection
|
6.2%
3/48 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
0.00%
0/52 • 20 weeks
Adverse events (serious and non-serious) of grade 3 or 4, definitely related/probably related/possibly related to study treatment, as assessed by Common Terminology Criteria for Adverse Events (CTCAE) version 4.03. Patients were systematically evaluated for toxicity at each visit.
|
Additional Information
Dr. Priyanka Sharma
University of Kansas Medical Center
Phone: 913-588-6029
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place