Trial Outcomes & Findings for Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer (NCT NCT01463072)
NCT ID: NCT01463072
Last Updated: 2025-07-28
Results Overview
Will be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment.
ACTIVE_NOT_RECRUITING
PHASE2
40 participants
During and after treatment, up to 2.5 years
2025-07-28
Participant Flow
Participant milestones
| Measure |
Treatment (Nab-paclitaxel)
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Overall Study
STARTED
|
40
|
|
Overall Study
COMPLETED
|
40
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Nab-Paclitaxel in Treating Older Patients With Locally Advanced or Metastatic Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Age, Continuous
|
73 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
38 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
2 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
7 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
33 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
|
6 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
|
4 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
29 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
40 Participants
n=5 Participants
|
|
Receptor status
HR-positive
|
30 Participants
n=5 Participants
|
|
Receptor status
Triple-negative
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: During and after treatment, up to 2.5 yearsWill be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 2 or higher toxicities attributed to treatment.
Outcome measures
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Percent of Participants With Grade 2-5 Toxicity Using National Cancer Institute Common Toxicity Criteria Version 4.0
|
90 percentage of participants
Interval 76.0 to 97.0
|
PRIMARY outcome
Timeframe: On treatment, 28 days per cycle up to 30 monthsWill be graded according to the National Cancer Institute (NCI) Common Terminology Criteria for Adverse Events (CTCAE) version 4.0. Rates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for grade 3 or higher toxicities attributed to treatment.
Outcome measures
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Percent of Participants With Grade 3 or Higher Toxicities Attributable to Treatment
|
58 percentage of participants
Interval 41.0 to 73.0
|
PRIMARY outcome
Timeframe: On treatment, up to 30 monthsRates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
Outcome measures
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Rate of Participants With a Dose Reduction
|
50 percentage of participants
Interval 34.0 to 66.0
|
PRIMARY outcome
Timeframe: While on treatment, up to 30 monthsRates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for dose reduction.
Outcome measures
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Rate of Participants Requiring Dose Holds
|
75 percentage of participants
Interval 59.0 to 87.0
|
SECONDARY outcome
Timeframe: Up to 2.5 yearsRates and associated 95% exact Clopper and Pearson binomial confidence limits will be estimated for objective response rate (complete response \[CR\] + partial response \[PR\]). RECIST: Complete Response (CR): Disappearance of all target lesions. Any pathological lymph nodes must have reduction in short axis to \<10 mm Partial Response (PR): At least a 30% decrease in the sum of diameters of target lesions, taking as reference the baseline sum diameters Progressive Disease (PD): At least a 20% increase in the sum of diameters of target lesions, taking as reference the smallest sum on study. Additionally, the sum must also demonstrate an absolute increase of at least 5 mm. The appearance of one or more new lesions is also considered progression Stable Disease (SD): Neither sufficient shrinkage to qualify for PR nor sufficient increase to qualify for PD, taking as reference the smallest sum diameters while on study
Outcome measures
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Response Determined by Response Evaluation Criteria in Solid Tumors
Complete remission
|
1 Participants
|
|
Response Determined by Response Evaluation Criteria in Solid Tumors
Partial remission
|
13 Participants
|
|
Response Determined by Response Evaluation Criteria in Solid Tumors
Stable disease
|
16 Participants
|
|
Response Determined by Response Evaluation Criteria in Solid Tumors
Progressive disease
|
4 Participants
|
|
Response Determined by Response Evaluation Criteria in Solid Tumors
Off treatment prior to disease assessment
|
6 Participants
|
SECONDARY outcome
Timeframe: From the date treatment begins until the first date on which recurrence, progression, or death due to any cause, assessed for about 1.5 yearsPFS will be estimated using the product limit method of Kaplan and Meier.
Outcome measures
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Median Progression Free Survival (PFS)
|
6.5 months
Interval 5.5 to
Insufficient number of participants with events
|
SECONDARY outcome
Timeframe: CARG measured prior to treatment, toxicities and dose reduction measured up to 30 monthsGeneral linear models and descriptive methods will be used to explore factors as identified by a CARG assessment that may be predictive of toxicity (grade 3 or higher adverse events) or dose reduction. The cancer specific geriatric assessment score includes an evaluation of functional status, co-morbidity, cognition, psychological stats, social functioning and support, and nutritional status. It assesses a patient's age, gender, height, weight, cancer type, dosage, number of chemotherapy agents, hemoglobin, hearing, number of falls in past 6 months, able to take own medicine, whether walking is limited, have physical or emotional problems interfered with social activities and serum creatinine. Scores can range from 0 to to 1, with a higher score indicating higher risk of chemotherapy toxicity. Scores from 0 to 5 are considered low risk, 6 to 9 are considered intermediate risk, and 10 to 19 are considered high risk.
Outcome measures
| Measure |
Treatment (Nab-paclitaxel)
n=40 Participants
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Cancer-specific Geriatric (CARG) Assessment
Low CARG chemotherapy toxicity risk
|
21 Participants
|
|
Cancer-specific Geriatric (CARG) Assessment
Intermediate CARG chemotherapy toxicity risk
|
15 Participants
|
|
Cancer-specific Geriatric (CARG) Assessment
High CARG chemotherapy toxicity risk
|
4 Participants
|
Adverse Events
Treatment (Nab-paclitaxel)
Serious adverse events
| Measure |
Treatment (Nab-paclitaxel)
n=40 participants at risk
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Cardiac disorders
Atrial fibrillation
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Cardiac disorders
Cardiac disorders - Other, specify
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Cardiac disorders
Heart failure
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Cardiac disorders
Supraventricular tachycardia
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Gastrointestinal disorders
Constipation
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Gastrointestinal disorders
Mucositis oral
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Gastrointestinal disorders
Nausea
|
10.0%
4/40 • On study, up to 2.5 years
|
|
Gastrointestinal disorders
Vomiting
|
10.0%
4/40 • On study, up to 2.5 years
|
|
General disorders
Fatigue
|
2.5%
1/40 • On study, up to 2.5 years
|
|
General disorders
Non-cardiac chest pain
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Immune system disorders
Allergic reaction
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Infections and infestations
Urinary tract infection
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Infections and infestations
Bronchial infection
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Investigations
Activated partial thromboplastin time prolonged
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Metabolism and nutrition disorders
Hyponatermia
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Muscle weakness upper limb
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Nervous system disorders
Headache
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Nervous system disorders
Stroke
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Hypoxia
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Respiratory failure
|
2.5%
1/40 • On study, up to 2.5 years
|
|
Vascular disorders
Hematoma
|
2.5%
1/40 • On study, up to 2.5 years
|
Other adverse events
| Measure |
Treatment (Nab-paclitaxel)
n=40 participants at risk
Patients receive nab-paclitaxel IV over 30 minutes on days 1, 8, and 15. Cycles repeat every 28 days in the absence of disease progression or unacceptable toxicity.
Laboratory Biomarker Analysis: Correlative studies
Nab-paclitaxel: Given IV
Questionnaire Administration: Ancillary studies
|
|---|---|
|
Blood and lymphatic system disorders
Anemia
|
47.5%
19/40 • On study, up to 2.5 years
|
|
Eye disorders
Conjunctivitis
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Gastrointestinal disorders
Diarrhea
|
10.0%
4/40 • On study, up to 2.5 years
|
|
General disorders
Edema limbs
|
5.0%
2/40 • On study, up to 2.5 years
|
|
General disorders
Pain
|
7.5%
3/40 • On study, up to 2.5 years
|
|
General disorders
Fatigue
|
57.5%
23/40 • On study, up to 2.5 years
|
|
Immune system disorders
Allergic reaction
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Infections and infestations
Nail infection
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Infections and infestations
Infections and infestations - Other, specify
|
7.5%
3/40 • On study, up to 2.5 years
|
|
Infections and infestations
Urinary tract infection
|
10.0%
4/40 • On study, up to 2.5 years
|
|
Infections and infestations
Skin infection
|
15.0%
6/40 • On study, up to 2.5 years
|
|
Infections and infestations
Upper respiratory infection
|
17.5%
7/40 • On study, up to 2.5 years
|
|
Investigations
Aspartate aminotransferase increased
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Investigations
Weight gain
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Investigations
Lymphocyte count decreased
|
20.0%
8/40 • On study, up to 2.5 years
|
|
Investigations
Neutrophil count decreased
|
42.5%
17/40 • On study, up to 2.5 years
|
|
Investigations
White blood cell decreased
|
62.5%
25/40 • On study, up to 2.5 years
|
|
Metabolism and nutrition disorders
Hyperglycemia
|
7.5%
3/40 • On study, up to 2.5 years
|
|
Metabolism and nutrition disorders
Hypokalemia
|
10.0%
4/40 • On study, up to 2.5 years
|
|
Metabolism and nutrition disorders
Dehydration
|
12.5%
5/40 • On study, up to 2.5 years
|
|
Metabolism and nutrition disorders
Hypocalcemia
|
15.0%
6/40 • On study, up to 2.5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
15.0%
6/40 • On study, up to 2.5 years
|
|
Respiratory, thoracic and mediastinal disorders
Dyspnea
|
7.5%
3/40 • On study, up to 2.5 years
|
|
Vascular disorders
Thromboembolic event
|
5.0%
2/40 • On study, up to 2.5 years
|
|
Vascular disorders
Hypotension
|
7.5%
3/40 • On study, up to 2.5 years
|
|
Vascular disorders
Hypertension
|
45.0%
18/40 • On study, up to 2.5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place