Trial Outcomes & Findings for Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer (NCT NCT01207102)
NCT ID: NCT01207102
Last Updated: 2014-12-15
Results Overview
The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.
Recruitment status
TERMINATED
Study phase
PHASE2
Target enrollment
10 participants
Primary outcome timeframe
PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes first
Results posted on
2014-12-15
Participant Flow
Participant milestones
| Measure |
Abraxane, Carboplatin
Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
0
|
|
Overall Study
NOT COMPLETED
|
10
|
Reasons for withdrawal
| Measure |
Abraxane, Carboplatin
Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
|
|---|---|
|
Overall Study
Withdrawal by Subject
|
5
|
|
Overall Study
Adverse Event
|
2
|
|
Overall Study
progression
|
2
|
|
Overall Study
Withdrawal by Treating Physician
|
1
|
Baseline Characteristics
Study Of Abraxane® And Carboplatin As First-Line Treatment For Triple Negative Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Abraxane, Carboplatin
n=10 Participants
Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
|
|---|---|
|
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
|
3 participants
n=5 Participants
|
|
Region of Enrollment
China
|
7 participants
n=5 Participants
|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
9 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
1 Participants
n=5 Participants
|
|
Age, Continuous
|
54.5 years
STANDARD_DEVIATION 8.1 • n=5 Participants
|
|
Sex: Female, Male
Female
|
10 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
7 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
|
2 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: PFS is defined as the interval from study registration to disease progression or death due to any cause, whichever comes firstPopulation: Due to insufficient accrual, data analysis was not performed.
The primary objective of the trial is to statistically test whether Abraxane® and carboplatin can improve progression-free survival (PFS) as compared to historical controls.
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 2 yearsPopulation: Due to insufficient accrual, data analysis was not performed.
The proportion of patients experiencing any neurotoxicity will be tabulated by grade. The proportion of patients experiencing ≥ grade 3 non-hematologic toxicities (excluding neurotoxicity) and the proportion of patients experiencing ≥ grade 3 hematologic toxicities will be calculated with their exact 80% confidence intervals.
Outcome measures
Outcome data not reported
Adverse Events
Abraxane, Carboplatin
Serious events: 6 serious events
Other events: 10 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Abraxane, Carboplatin
n=10 participants at risk
Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
40.0%
4/10
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
1/10
|
|
Immune system disorders
Allergic reaction
|
10.0%
1/10
|
|
Investigations
Neutrophil count decreased
|
50.0%
5/10
|
|
Investigations
Platelet count decreased
|
10.0%
1/10
|
|
Investigations
White blood cell decreased
|
10.0%
1/10
|
Other adverse events
| Measure |
Abraxane, Carboplatin
n=10 participants at risk
Abraxane 100mg/m2 IV days 1, 8 and 15 of a 28 day cycle Carboplatin area under the concentration curve, (AUC)2 IV days 1,8, and 15 of a 28 day Cycle
Abraxane: Abraxane® 100 mg/m2 IV over 30 min days 1,8,15 every 28 days
Carboplatin: area under curve(AUC)=2 over 15 minutes days 1,8,15 every 28 days
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
60.0%
6/10
|
|
Blood and lymphatic system disorders
Blood and lymphatic system disorders - Other, specify: lymphedema
|
10.0%
1/10
|
|
Cardiac disorders
Ventricular tachycardia
|
10.0%
1/10
|
|
Eye disorders
Eye disorders - Other, specify: floaters
|
10.0%
1/10
|
|
Gastrointestinal disorders
Abdominal pain
|
10.0%
1/10
|
|
Gastrointestinal disorders
Constipation
|
10.0%
1/10
|
|
Gastrointestinal disorders
Diarrhea
|
20.0%
2/10
|
|
Gastrointestinal disorders
Gastritis
|
10.0%
1/10
|
|
Gastrointestinal disorders
Nausea
|
60.0%
6/10
|
|
Gastrointestinal disorders
Vomiting
|
50.0%
5/10
|
|
General disorders
Chills
|
10.0%
1/10
|
|
General disorders
Edema limbs
|
40.0%
4/10
|
|
General disorders
Fatigue
|
30.0%
3/10
|
|
General disorders
Fever
|
10.0%
1/10
|
|
General disorders
General disorders and administration site conditions - Other, specify: cold intolerance
|
10.0%
1/10
|
|
General disorders
Non-cardiac chest pain
|
10.0%
1/10
|
|
General disorders
Pain
|
20.0%
2/10
|
|
Immune system disorders
Allergic reaction
|
20.0%
2/10
|
|
Infections and infestations
Infections -Other: Infection with Grade 3 or 4 neutrophils (ANC <1.0 x 10e9/L)
|
10.0%
1/10
|
|
Infections and infestations
Sinusitis
|
10.0%
1/10
|
|
Infections and infestations
Vaginal infection
|
10.0%
1/10
|
|
Investigations
Alanine aminotransferase increased
|
40.0%
4/10
|
|
Investigations
Aspartate aminotransferase increased
|
30.0%
3/10
|
|
Investigations
Neutrophil count decreased
|
90.0%
9/10
|
|
Investigations
Platelet count decreased
|
40.0%
4/10
|
|
Investigations
White blood cell decreased
|
20.0%
2/10
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
30.0%
3/10
|
|
Musculoskeletal and connective tissue disorders
Musculoskeletal and connective tissue disorder - Other, specify: toes stiff upon standing
|
10.0%
1/10
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
10.0%
1/10
|
|
Nervous system disorders
Dizziness
|
10.0%
1/10
|
|
Nervous system disorders
Dysgeusia
|
10.0%
1/10
|
|
Nervous system disorders
Memory impairment
|
10.0%
1/10
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
30.0%
3/10
|
|
Psychiatric disorders
Anxiety
|
20.0%
2/10
|
|
Renal and urinary disorders
Urinary frequency
|
10.0%
1/10
|
|
Reproductive system and breast disorders
Vaginal dryness
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Allergic rhinitis
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
30.0%
3/10
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
10.0%
1/10
|
|
Respiratory, thoracic and mediastinal disorders
Pharyngolaryngeal pain
|
20.0%
2/10
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory, thoracic and mediastinal disorders - Other, specify: yellow sputum
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
30.0%
3/10
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Nail loss
|
10.0%
1/10
|
|
Skin and subcutaneous tissue disorders
Urticaria
|
10.0%
1/10
|
|
Vascular disorders
Flushing
|
10.0%
1/10
|
|
Vascular disorders
Hot flashes
|
10.0%
1/10
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place