Trial Outcomes & Findings for ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer (NCT NCT00110084)
NCT ID: NCT00110084
Last Updated: 2011-06-02
Results Overview
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
50 participants
Primary outcome timeframe
Two consecutive evaluations at least 6 weeks apart
Results posted on
2011-06-02
Participant Flow
Participants were recruited from 22 medical clinics in the United States between November 2005 to May 2006
Participant milestones
| Measure |
Nab-paclitaxel/Gemcitabine
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
Overall Study
STARTED
|
50
|
|
Overall Study
COMPLETED
|
22
|
|
Overall Study
NOT COMPLETED
|
28
|
Reasons for withdrawal
| Measure |
Nab-paclitaxel/Gemcitabine
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
Overall Study
Adverse Event
|
9
|
|
Overall Study
Death
|
1
|
|
Overall Study
Patient Refusal
|
10
|
|
Overall Study
Alternate Therapy
|
5
|
|
Overall Study
Intercurrent Illness
|
1
|
|
Overall Study
Other
|
2
|
Baseline Characteristics
ABI-007 (Nab-Paclitaxel) and Gemcitabine in Treating Women With Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Nab-paclitaxel/Gemcitabine
n=50 Participants
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
Age Continuous
|
56 years
n=39 Participants
|
|
Sex/Gender, Customized
Female
|
50 participants
n=39 Participants
|
|
Region of Enrollment
United States
|
50 participants
n=39 Participants
|
|
Dominant disease site
Soft tissue
|
5 participants
n=39 Participants
|
|
Dominant disease site
Osseous
|
4 participants
n=39 Participants
|
|
Dominant disease site
Visceral
|
41 participants
n=39 Participants
|
|
Estrogen receptor status
Positive
|
34 participants
n=39 Participants
|
|
Estrogen receptor status
Negative
|
14 participants
n=39 Participants
|
|
Estrogen receptor status
Unknown
|
2 participants
n=39 Participants
|
|
HER2 (human epidermal growth factor receptor 2) status
Positive
|
1 participants
n=39 Participants
|
|
HER2 (human epidermal growth factor receptor 2) status
Negative
|
49 participants
n=39 Participants
|
|
Number of metastatic sites
1
|
5 participants
n=39 Participants
|
|
Number of metastatic sites
2
|
15 participants
n=39 Participants
|
|
Number of metastatic sites
3+
|
30 participants
n=39 Participants
|
|
Performance Score
0 - Fully Active
|
23 participants
n=39 Participants
|
|
Performance Score
1 - Ambulatory, restricted strenuous activity
|
27 participants
n=39 Participants
|
|
Progesterone receptor status
Positive
|
28 participants
n=39 Participants
|
|
Progesterone receptor status
Negative
|
20 participants
n=39 Participants
|
|
Progesterone receptor status
Unknown
|
2 participants
n=39 Participants
|
PRIMARY outcome
Timeframe: Two consecutive evaluations at least 6 weeks apartPopulation: per protocol
Confirmed tumor response (complete and partial) as measured by RECIST(Response Evaluation Criteria In Solid Tumors) criteria on 2 consecutive evaluations at least 6 weeks apart. Confirmed tumor response is at least a 30% decrease in the sum of the longest diameter of target lesions and no new lesions.
Outcome measures
| Measure |
Nab-paclitaxel/Gemcitabine
n=50 Participants
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
Proportion of Patients With Confirmed Responses
Confirmed response
|
25 participants
|
|
Proportion of Patients With Confirmed Responses
Assessable
|
50 participants
|
SECONDARY outcome
Timeframe: Time from registration to progression or death (up to 5 years)Progression-free survival was defined as the number of months from registration to the date of disease progression or death, with patients who are alive and progression free being censored on the date of their last evaluation.
Outcome measures
| Measure |
Nab-paclitaxel/Gemcitabine
n=50 Participants
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
Progression-free Survival
|
7.9 months
Interval 5.4 to 10.0
|
SECONDARY outcome
Timeframe: Death or last follow-up (up to 5 years)Population: Median survival time from Kaplan-meir estimate has not been attained.
Overall survival time was defined as the number of days from registration to the date of death or last follow-up
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Every 6 weeksNumber of patients that experienced adverse events (grade 3 or more occurring in \>5% of patients) as measured by NCI CTCAE (Common Terminology Criteria for Adverse Events) v3.0
Outcome measures
| Measure |
Nab-paclitaxel/Gemcitabine
n=50 Participants
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
Adverse Event
Neutropenia
|
27 participants
|
|
Adverse Event
Fatigue
|
14 participants
|
|
Adverse Event
Anemia
|
7 participants
|
|
Adverse Event
Dyspnea
|
7 participants
|
|
Adverse Event
Thrombocytopenia
|
6 participants
|
|
Adverse Event
Arthralgia
|
4 participants
|
|
Adverse Event
Vomiting
|
4 participants
|
|
Adverse Event
Neuropathy
|
3 participants
|
|
Adverse Event
Myalgia
|
3 participants
|
|
Adverse Event
Nausea
|
3 participants
|
|
Adverse Event
Pain-abdominal
|
3 participants
|
|
Adverse Event
Aspartate aminotransferase (AST)
|
3 participants
|
Adverse Events
Nab-paclitaxel/Gemcitabine
Serious events: 11 serious events
Other events: 50 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Nab-paclitaxel/Gemcitabine
n=50 participants at risk
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
6.0%
3/50 • Number of events 3
|
|
Blood and lymphatic system disorders
Febrile neutropenia
|
2.0%
1/50 • Number of events 1
|
|
Cardiac disorders
Arrythmia
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Ileus
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Nausea
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Pain-Abdominal
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Bronchial infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Neutropenia
|
4.0%
2/50 • Number of events 3
|
|
Investigations
Platelet count decreased
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
2.0%
1/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pulmonary
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Erythema multiforme
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Hypotension
|
2.0%
1/50 • Number of events 1
|
Other adverse events
| Measure |
Nab-paclitaxel/Gemcitabine
n=50 participants at risk
Nab (nanoparticle albumin-bound)-Paclitaxel (125mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle and gemcitabine (1000 mg/m\^2)(IV over 30 min) (days 1 and 8) on 21 day cycle
|
|---|---|
|
General disorders
Edema: Head/Neck
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Edema: Limb
|
16.0%
8/50 • Number of events 14
|
|
General disorders
Edema: trunk/genital
|
2.0%
1/50 • Number of events 1
|
|
General disorders
Fatigue
|
96.0%
48/50 • Number of events 269
|
|
Blood and lymphatic system disorders
Anemia
|
94.0%
47/50 • Number of events 302
|
|
Cardiac disorders
Atrial fibrillation
|
4.0%
2/50 • Number of events 2
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.0%
1/50 • Number of events 1
|
|
Eye disorders
Vision-Blurred
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Constipation
|
6.0%
3/50 • Number of events 3
|
|
Gastrointestinal disorders
Diarrhea-No Colostom
|
36.0%
18/50 • Number of events 33
|
|
Gastrointestinal disorders
Nausea
|
60.0%
30/50 • Number of events 101
|
|
Gastrointestinal disorders
Oral cavity Mucositis/stomatitis (clinical exam)
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Oral cavity Mucositis/stomatitis (functional/symptomatic)
|
36.0%
18/50 • Number of events 35
|
|
Gastrointestinal disorders
Pain-Abdominal
|
8.0%
4/50 • Number of events 7
|
|
Gastrointestinal disorders
Pain-Stomach
|
2.0%
1/50 • Number of events 1
|
|
Gastrointestinal disorders
Vomiting
|
36.0%
18/50 • Number of events 34
|
|
General disorders
Fever-No ANC
|
32.0%
16/50 • Number of events 26
|
|
General disorders
Pain
|
6.0%
3/50 • Number of events 3
|
|
Immune system disorders
Hypersensitivity
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Bladder infection
|
6.0%
3/50 • Number of events 3
|
|
Infections and infestations
Bronchial infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Catheter related infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Infection
|
6.0%
3/50 • Number of events 5
|
|
Infections and infestations
Lung (pneumonia) infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Pleural infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Sepsis
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Sinus infection
|
2.0%
1/50 • Number of events 2
|
|
Infections and infestations
Skin (cellulites) infection
|
2.0%
1/50 • Number of events 1
|
|
Infections and infestations
Skin infection
|
6.0%
3/50 • Number of events 3
|
|
Infections and infestations
Urinary tract infection
|
6.0%
3/50 • Number of events 4
|
|
Investigations
Alanine aminotransferase increased
|
14.0%
7/50 • Number of events 14
|
|
Investigations
Alkaline phosphatase
|
4.0%
2/50 • Number of events 5
|
|
Investigations
Amylase
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Aspartate aminotransferase increased
|
14.0%
7/50 • Number of events 12
|
|
Investigations
Blood bilirubin increased
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Leukopenia
|
20.0%
10/50 • Number of events 16
|
|
Investigations
Lipase increased
|
2.0%
1/50 • Number of events 5
|
|
Investigations
Lymphopenia
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Metabolic/Lab
|
2.0%
1/50 • Number of events 2
|
|
Investigations
Neutropenia
|
88.0%
44/50 • Number of events 194
|
|
Investigations
Platelet count decreased
|
80.0%
40/50 • Number of events 121
|
|
Investigations
Weight gain
|
2.0%
1/50 • Number of events 1
|
|
Investigations
Weight loss
|
2.0%
1/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Anorexia
|
10.0%
5/50 • Number of events 9
|
|
Metabolism and nutrition disorders
Dehydration
|
2.0%
1/50 • Number of events 1
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
6.0%
3/50 • Number of events 6
|
|
Metabolism and nutrition disorders
Hypoalbuminemia
|
8.0%
4/50 • Number of events 21
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
8.0%
4/50 • Number of events 5
|
|
Metabolism and nutrition disorders
Hypokalemia
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
60.0%
30/50 • Number of events 117
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
2.0%
1/50 • Number of events 5
|
|
Musculoskeletal and connective tissue disorders
Bone pain
|
4.0%
2/50 • Number of events 2
|
|
Musculoskeletal and connective tissue disorders
Chest wall pain
|
2.0%
1/50 • Number of events 4
|
|
Musculoskeletal and connective tissue disorders
Extremity-lower weakness
|
2.0%
1/50 • Number of events 1
|
|
Musculoskeletal and connective tissue disorders
Muscle Weakness
|
6.0%
3/50 • Number of events 3
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
58.0%
29/50 • Number of events 94
|
|
Nervous system disorders
Ataxia
|
2.0%
1/50 • Number of events 1
|
|
Nervous system disorders
Dizziness
|
2.0%
1/50 • Number of events 2
|
|
Nervous system disorders
Dysgeusia
|
2.0%
1/50 • Number of events 3
|
|
Nervous system disorders
Headache
|
4.0%
2/50 • Number of events 3
|
|
Nervous system disorders
Peripheral motor neuropathy
|
2.0%
1/50 • Number of events 2
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
52.0%
26/50 • Number of events 145
|
|
Nervous system disorders
Syncope
|
2.0%
1/50 • Number of events 1
|
|
Psychiatric disorders
Depression
|
2.0%
1/50 • Number of events 2
|
|
Renal and urinary disorders
Proteinuria
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
6.0%
3/50 • Number of events 4
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
60.0%
30/50 • Number of events 115
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pharynx Mucositis/stomatitis (functional/symptomatic)
|
4.0%
2/50 • Number of events 2
|
|
Respiratory, thoracic and mediastinal disorders
Pleural effusion
|
2.0%
1/50 • Number of events 1
|
|
Respiratory, thoracic and mediastinal disorders
Pneumonitis
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
90.0%
45/50 • Number of events 304
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
2.0%
1/50 • Number of events 1
|
|
Skin and subcutaneous tissue disorders
Hand-foot skin reaction
|
10.0%
5/50 • Number of events 16
|
|
Skin and subcutaneous tissue disorders
Pruritus
|
4.0%
2/50 • Number of events 3
|
|
Skin and subcutaneous tissue disorders
Rash/Desquamation
|
8.0%
4/50 • Number of events 7
|
|
Skin and subcutaneous tissue disorders
Skin Irritation
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Flushing
|
2.0%
1/50 • Number of events 3
|
|
Vascular disorders
Phlebitis
|
2.0%
1/50 • Number of events 1
|
|
Vascular disorders
Thrombosis
|
2.0%
1/50 • Number of events 1
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place