Trial Outcomes & Findings for Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer (NCT NCT02547987)
NCT ID: NCT02547987
Last Updated: 2025-03-12
Results Overview
This is the complete disappearance of invasive cancer in the breast at the time of surgery
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
25 participants
Primary outcome timeframe
At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)
Results posted on
2025-03-12
Participant Flow
Patient eligibility is confirmed by both the study coordinator and a Lester \& Sue Smith Breast Center physician. If a patient does not meet an inclusion criterion, or meets an exclusion criterion, as listed in the protocol section, the patient is excluded.
Participant milestones
| Measure |
Docetaxel/Carboplatin
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6
|
|---|---|
|
Overall Study
STARTED
|
25
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
3
|
Reasons for withdrawal
| Measure |
Docetaxel/Carboplatin
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Neoadjuvant Carboplatin and Docetaxel in Triple Negative Breast Cancer
Baseline characteristics by cohort
| Measure |
Docetaxel/Carboplatin
n=25 Participants
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
16 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Female
|
25 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
9 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
16 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
2 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
22 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
25 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: At the time of definitive surgery (approximately 4-5 months after beginning chemotherapy)This is the complete disappearance of invasive cancer in the breast at the time of surgery
Outcome measures
| Measure |
Docetaxel/Carboplatin
n=25 Participants
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6
|
|---|---|
|
Pathologic Complete Response
|
10 Participants
|
Adverse Events
Docetaxel/Carboplatin
Serious events: 3 serious events
Other events: 16 other events
Deaths: 1 deaths
Serious adverse events
| Measure |
Docetaxel/Carboplatin
n=25 participants at risk
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6
|
|---|---|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
4.0%
1/25 • Number of events 1 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Ear and labyrinth disorders
Vertigo
|
4.0%
1/25 • Number of events 1 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Colitis
|
4.0%
1/25 • Number of events 1 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
4.0%
1/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Infections and infestations
Urinary tract infection
|
4.0%
1/25 • Number of events 1 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
Other adverse events
| Measure |
Docetaxel/Carboplatin
n=25 participants at risk
Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV on Day 1 of each 21 day cycle for 6 cycles
Docetaxel/Carboplatin: Docetaxel 75 mg/m2 plus Carboplatin AUC 6 IV (in the vein) on day 1 of each 21-day cycle. Number of Cycles: 6
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
36.0%
9/25 • Number of events 15 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Eye disorders
Eyelid function disorder
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Constipation
|
12.0%
3/25 • Number of events 3 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Diarrhea
|
28.0%
7/25 • Number of events 15 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Dyspepsia
|
16.0%
4/25 • Number of events 5 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Gastrointestinal disorders - Other, specify
|
8.0%
2/25 • Number of events 3 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Mucositis oral
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Nausea
|
20.0%
5/25 • Number of events 7 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Gastrointestinal disorders
Vomiting
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
General disorders
Fatigue
|
32.0%
8/25 • Number of events 13 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
General disorders
Pain
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Infections and infestations
Skin infection
|
12.0%
3/25 • Number of events 4 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Investigations
Alanine aminotransferase increased
|
12.0%
3/25 • Number of events 4 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Investigations
Aspartate aminotransferase increased
|
16.0%
4/25 • Number of events 5 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Investigations
Creatinine increased
|
8.0%
2/25 • Number of events 3 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Investigations
Lymphocyte count decreased
|
12.0%
3/25 • Number of events 7 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Investigations
Neutrophil count decreased
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Investigations
Platelet count decreased
|
24.0%
6/25 • Number of events 9 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Investigations
White blood cell decreased
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Anorexia
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
8.0%
2/25 • Number of events 6 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
20.0%
5/25 • Number of events 7 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hypokalemia
|
12.0%
3/25 • Number of events 5 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Metabolism and nutrition disorders
Hyponatremia
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Arthritis
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
8.0%
2/25 • Number of events 3 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
20.0%
5/25 • Number of events 6 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Nervous system disorders
Dizziness
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Nervous system disorders
Dysgeusia
|
24.0%
6/25 • Number of events 6 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Nervous system disorders
Headache
|
20.0%
5/25 • Number of events 6 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
12.0%
3/25 • Number of events 4 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Psychiatric disorders
Insomnia
|
12.0%
3/25 • Number of events 4 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Respiratory, thoracic and mediastinal disorders
Sore throat
|
8.0%
2/25 • Number of events 3 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
28.0%
7/25 • Number of events 11 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Nail discoloration
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
|
Skin and subcutaneous tissue disorders
Skin and subcutaneous tissue disorders - Other, specify
|
8.0%
2/25 • Number of events 2 • 6.5 months (from screening/baseline to 30 days after completion of all cycles).
Adverse events were assessed at baseline, at the start of each 21-day cycle, and up to 30 days after completion of all cycles using descriptions and grading scales found in CTCAE v4.0.
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place