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Trial record 1 of 1 for:    NCT01746225
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Schedules of Nab-Paclitaxel in Metastatic Breast Cancer (SNAP)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT01746225
Recruitment Status : Active, not recruiting
First Posted : December 10, 2012
Results First Posted : March 27, 2020
Last Update Posted : March 27, 2020
Sponsor:
Collaborator:
Breast International Group
Information provided by (Responsible Party):
International Breast Cancer Study Group

Study Type Interventional
Study Design Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Condition Metastatic Breastcancer
Intervention Drug: nab-Paclitaxel
Enrollment 258
Recruitment Details 255 patients were randomized between 16April2013 and 7August2015 at 35 centers in 5 countries.
Pre-assignment Details  
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Period Title: Overall Study
Started 83 86 86
Completed 43 40 43
Not Completed 40 46 43
Reason Not Completed
Death             1             0             1
Withdrawal by Subject             5             15             19
Physician Decision             14             11             3
Adverse Event             15             12             17
Continuing Treatment             5             8             3
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22 Total
Hide Arm/Group Description

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

Total of all reporting groups
Overall Number of Baseline Participants 83 86 86 255
Hide Baseline Analysis Population Description
Intention-to-treat population. Arm A had randomized 86 patient, but only 83 were analyzed. 3 patients excluded from analysis, who immediately withdrew consent or cancelled treatment.
Age, Continuous  
Median (Inter-Quartile Range)
Unit of measure:  Years
Number Analyzed 83 participants 86 participants 86 participants 255 participants
58
(49 to 67)
56
(45 to 65)
60
(52 to 68)
58
(49 to 67)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 86 participants 86 participants 255 participants
Female
83
 100.0%
86
 100.0%
86
 100.0%
255
 100.0%
Male
0
   0.0%
0
   0.0%
0
   0.0%
0
   0.0%
Race/Ethnicity, Customized  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 86 participants 86 participants 255 participants
White/Caucasian
83
 100.0%
85
  98.8%
85
  98.8%
253
  99.2%
Asian
0
   0.0%
1
   1.2%
1
   1.2%
2
   0.8%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Number Analyzed 83 participants 86 participants 86 participants 255 participants
Belgium 10 10 11 33
Ireland 21 22 18 61
Italy 12 16 12 40
Slovenia 3 1 3 7
Switzerland 20 25 29 75
Spain 17 12 13 42
ER Status  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 86 participants 86 participants 255 participants
Positive
72
  86.7%
69
  80.2%
69
  80.2%
210
  82.4%
Negative
11
  13.3%
17
  19.8%
17
  19.8%
45
  17.6%
Prior Taxanes  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 86 participants 86 participants 255 participants
Yes
26
  31.3%
28
  32.6%
26
  30.2%
80
  31.4%
No
57
  68.7%
58
  67.4%
60
  69.8%
175
  68.6%
Type of Radiologically Evaluable Disease  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 83 participants 86 participants 86 participants 255 participants
Measurable
68
  81.9%
73
  84.9%
69
  80.2%
210
  82.4%
Non-measurable only
15
  18.1%
13
  15.1%
17
  19.8%
45
  17.6%
1.Primary Outcome
Title Progression-free Survival
Hide Description Time from randomization until objective disease progression [progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions] or death, whichever occurs first. For patients without progression, follow-up was censored at the date of last disease assessment without progression, unless death occurred within a short period of time (12 weeks) following the date last known progression-free, in which case the death was counted as a PFS event.
Time Frame Reported after 18.2 months median follow-up since randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Intention-to-treat population
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description:

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Overall Number of Participants Analyzed 83 86 86
Median (90% Confidence Interval)
Unit of Measure: months
7.9
(6.8 to 8.4)
9.0
(8.1 to 10.9)
8.5
(6.7 to 9.5)
Hide Statistical Analysis 1
Statistical Analysis Overview Comparison Group Selection A: Nab-Paclitaxel 150 mg/m2 Days 1,15
Comments For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value 0.12
Comments Not adjusted for multiple comparisons; One-sided .05 alpha-level test
Method Log Rank
Comments One-sided test
Hide Statistical Analysis 2
Statistical Analysis Overview Comparison Group Selection B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15
Comments For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .03
Comments Not adjusted for multiple comparisons; One-sided .05 alpha-level test
Method Log Rank
Comments One-sided test
Hide Statistical Analysis 3
Statistical Analysis Overview Comparison Group Selection C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Comments For each arm separately, PFS was compared to the historic PFS of first-line docetaxel using a one-sample one-sided log-rank test, of the null hypothesis, H0: median PFS≤7 months vs. H1: median PFS>7 months.
Type of Statistical Test Superiority
Comments [Not Specified]
Statistical Test of Hypothesis P-Value .20
Comments Not adjusted for multiple comparisons; One-sided .05 alpha-level test
Method Log Rank
Comments One-sided test
2.Secondary Outcome
Title Feasibility of Treatment: Number of Participants Completed Treatment According to the Protocol for at Least 24 Weeks
Hide Description Whether or not the patient completed treatment according to the protocol for at least 24 weeks. Patients who progressed within 24 weeks were considered as not completing.
Time Frame Baseline to 24 weeks follow-up
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description:

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Overall Number of Participants Analyzed 83 86 86
Measure Type: Count of Participants
Unit of Measure: Participants
40
  48.2%
43
  50.0%
44
  51.2%
3.Secondary Outcome
Title Disease Control: Overall Response of Stable Disease for a Duration of ≥24 Weeks
Hide Description Overall response of stable disease (or non-CR/non-PD for patients with non-measurable disease) for a duration of ≥24 weeks, or better (i.e., partial or complete response) according to RECIST criteria [Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.]
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description:

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Overall Number of Participants Analyzed 83 86 86
Measure Type: Count of Participants
Unit of Measure: Participants
54
  65.1%
59
  68.6%
52
  60.5%
4.Secondary Outcome
Title Best Overall Response
Hide Description Best response according to RECIST 1.1 criteria [assessed by MRI] recorded from the start of treatment across all time points until end of study treatment. Confirmation of partial or complete response by an additional scan was not requested in this trial.
Time Frame From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 18 months
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description:

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Overall Number of Participants Analyzed 83 86 86
Measure Type: Count of Participants
Unit of Measure: Participants
Complete Response (CR)
5
   6.0%
6
   7.0%
4
   4.7%
Partial Response (PR)
34
  41.0%
41
  47.7%
35
  40.7%
Stable Disease (SD)/Non-CR/Non-PD
39
  47.0%
33
  38.4%
31
  36.0%
Progressive Disease (PD)
3
   3.6%
5
   5.8%
11
  12.8%
Not Evaluable (NE)
2
   2.4%
1
   1.2%
5
   5.8%
5.Secondary Outcome
Title Overall Survival
Hide Description Time from randomization until death from any cause, or censored at date last known alive
Time Frame Reported after 18.2 months median follow-up since randomization
Hide Outcome Measure Data
Hide Analysis Population Description
Intention to treat population
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description:

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Overall Number of Participants Analyzed 83 86 86
Median (90% Confidence Interval)
Unit of Measure: months
25.8 [1] 
(16.9 to NA)
26.2 [1] 
(21.0 to NA)
25.5 [1] 
(22.7 to NA)
[1]
Not reported, insufficient number of participants with events.
6.Secondary Outcome
Title Changes in Physical Well-being (Change From Day 1 of Cycle 4 to Day 1 of Cycle 6)
Hide Description Primary quality of life=physical well being; endpoint based on the GLQ 8. The indicator was in Linear Analogue Self-Assessment (LASA) format ranging 0-100 (0=as bad as it can be, 100=as good as it can be).
Time Frame Assessed from day 1 of cycle 4 through day 1 of cycle 12
Hide Outcome Measure Data
Hide Analysis Population Description
Patients who started the maintenance phase of treatment (cycle 4)
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description:

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Overall Number of Participants Analyzed 66 72 61
Mean (95% Confidence Interval)
Unit of Measure: units on a scale
-2
(-9 to 5)
1
(-6 to 7)
4
(-4 to 11)
Time Frame Assessed every 28-day cycle while on treatment and for 30 days after the end of treatment, up to 18 months
Adverse Event Reporting Description Targeted AEs and other grade 3 or higher AEs were collected on CRFs, regardless of attribution.
 
Arm/Group Title A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Hide Arm/Group Description

Arm A: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 150 mg/m2 administered on days 1, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm B: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 100 mg/m2 administered on days 1, 8, 15 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

Arm C: Induction* nab-Paclitaxel 125 mg/m2 on days 1,8,15 every 28 days for 3 cycles followed by maintenance nab-Paclitaxel 75 mg/m2 administered on days 1, 8, 15, 22 of each 28-day cycle (total 300mg/m2 per cycle) until progression or unacceptable toxicity.

nab-Paclitaxel: Induction phase: 3 cycles of nab-Paclitaxel days 1, 8, 15. Maintenance phase with three maintenance schedules of nab-Paclitaxel (same total dose per cycle, different number of administrations)

*Following Amendment 1, the dose in the induction phase dose in all three arms was reduced to 125 mg/m² from 150 mg/m².

All-Cause Mortality
A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   --/--   --/--   --/-- 
Hide Serious Adverse Events
A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   51/83 (61.45%)   43/86 (50.00%)   57/86 (66.28%) 
Blood and lymphatic system disorders       
Anemia  1  5/83 (6.02%)  2/86 (2.33%)  0/86 (0.00%) 
Febrile Neutropenia  1  2/83 (2.41%)  2/86 (2.33%)  0/86 (0.00%) 
Cardiac disorders       
Pericardial effusion  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Ear and labyrinth disorders       
Vertigo  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Eye disorders       
Cataract  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Dry eye  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Gastrointestinal disorders       
Abdominal pain  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Ascites  1  1/83 (1.20%)  0/86 (0.00%)  1/86 (1.16%) 
Diarrhea  1  7/83 (8.43%)  3/86 (3.49%)  2/86 (2.33%) 
Ileal obstruction  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Ileus  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Mucositis oral  1  2/83 (2.41%)  1/86 (1.16%)  0/86 (0.00%) 
Nausea  1  2/83 (2.41%)  1/86 (1.16%)  1/86 (1.16%) 
Pancreatitis  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Periodontal disease  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Stomach pain  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Vomiting  1  1/83 (1.20%)  1/86 (1.16%)  3/86 (3.49%) 
General disorders       
Edema limbs  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Fatigue  1  4/83 (4.82%)  4/86 (4.65%)  9/86 (10.47%) 
Fever  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Multi-organ failure  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Pain  1  3/83 (3.61%)  0/86 (0.00%)  2/86 (2.33%) 
Hepatobiliary disorders       
Cholecystitis  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Hepatic failure  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Infections and infestations       
Appendicitis  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Bronchial infection  1  0/83 (0.00%)  0/86 (0.00%)  2/86 (2.33%) 
Lung infection  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Nail infection  1  0/83 (0.00%)  1/86 (1.16%)  1/86 (1.16%) 
Paronychia  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Rhinitis infective  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Sepsis  1  0/83 (0.00%)  2/86 (2.33%)  1/86 (1.16%) 
Skin infection  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Soft tissue infection  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Upper respiratory infection  1  0/83 (0.00%)  1/86 (1.16%)  1/86 (1.16%) 
Urinary tract infection  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Wound infection  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Injury, poisoning and procedural complications       
Fracture  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Hip fracture  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Radiation recall reaction (dermatologic)  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Spinal fracture  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Vascular access complication  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Investigations       
Neutrophil count decreased  1  18/83 (21.69%)  24/86 (27.91%)  21/86 (24.42%) 
Platelet count decreased  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Alanine aminotransferase increased  1  3/83 (3.61%)  0/86 (0.00%)  1/86 (1.16%) 
Alkaline phosphatase increased  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Aspartate aminotransferase increased  1  3/83 (3.61%)  0/86 (0.00%)  1/86 (1.16%) 
Creatinine increased  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
GGT increased  1  3/83 (3.61%)  1/86 (1.16%)  2/86 (2.33%) 
Weight gain  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
White blood cell decreased  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Metabolism and nutrition disorders       
Anorexia  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Hypokalemia  1  3/83 (3.61%)  0/86 (0.00%)  0/86 (0.00%) 
Hyponatremia  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Hypophosphatemia  1  1/83 (1.20%)  0/86 (0.00%)  1/86 (1.16%) 
Musculoskeletal and connective tissue disorders       
Arthralgia  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Back pain  1  0/83 (0.00%)  2/86 (2.33%)  1/86 (1.16%) 
Bone pain  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Musculoskeletal and connective - Other  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Myalgia  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Osteonecrosis of jaw  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Pain in extremity  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Nervous system disorders       
Peripheral Sensory Neuropathy  1  7/83 (8.43%)  4/86 (4.65%)  5/86 (5.81%) 
Nervous system disorders - Other  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Seizure  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Spasticity  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Syncope  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Psychiatric disorders       
Anxiety  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Depression  1  2/83 (2.41%)  0/86 (0.00%)  1/86 (1.16%) 
Renal and urinary disorders       
Renal and urinary disorders - Other  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Urinary tract obstruction  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Reproductive system and breast disorders       
Reproductive system and breast  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Breast pain  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Pelvic pain  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Respiratory, thoracic and mediastinal disorders       
Bronchial obstruction  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Dyspnea  1  1/83 (1.20%)  2/86 (2.33%)  1/86 (1.16%) 
Epistaxis  1  0/83 (0.00%)  1/86 (1.16%)  1/86 (1.16%) 
Laryngeal stenosis  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Pleural effusion  1  1/83 (1.20%)  0/86 (0.00%)  0/86 (0.00%) 
Respiratory thoracic mediastinal - Other,10038738  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Skin and subcutaneous tissue disorders       
Nail ridging  1  1/83 (1.20%)  0/86 (0.00%)  1/86 (1.16%) 
Periorbital edema  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Photosensitivity  1  0/83 (0.00%)  1/86 (1.16%)  0/86 (0.00%) 
Vascular disorders       
Hypertension  1  1/83 (1.20%)  5/86 (5.81%)  4/86 (4.65%) 
Thromboembolic event  1  3/83 (3.61%)  3/86 (3.49%)  4/86 (4.65%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
A: Nab-Paclitaxel 150 mg/m2 Days 1,15 B: Nab-Paclitaxel 100 mg/m2 Days 1,8,15 C: Nab-Paclitaxel 75 mg/m2 Days 1,8,15,22
Affected / at Risk (%) Affected / at Risk (%) Affected / at Risk (%)
Total   78/83 (93.98%)   83/86 (96.51%)   80/86 (93.02%) 
Blood and lymphatic system disorders       
Anemia  1  46/83 (55.42%)  55/86 (63.95%)  55/86 (63.95%) 
Cardiac disorders       
Heart Failure  1  0/83 (0.00%)  0/86 (0.00%)  3/86 (3.49%) 
Sinus Tachycardia  1  2/83 (2.41%)  4/86 (4.65%)  3/86 (3.49%) 
Gastrointestinal disorders       
Nausea  1  32/83 (38.55%)  31/86 (36.05%)  40/86 (46.51%) 
Vomiting  1  10/83 (12.05%)  11/86 (12.79%)  17/86 (19.77%) 
Diarrhea  1  21/83 (25.30%)  28/86 (32.56%)  27/86 (31.40%) 
Immune system disorders       
Allergic Reaction  1  8/83 (9.64%)  4/86 (4.65%)  4/86 (4.65%) 
Investigations       
Neutrophil count decreased  1  28/83 (33.73%)  35/86 (40.70%)  42/86 (48.84%) 
Platelet count decreased  1  8/83 (9.64%)  8/86 (9.30%)  4/86 (4.65%) 
Nervous system disorders       
Peripheral Sensory Neuropathy  1  51/83 (61.45%)  58/86 (67.44%)  55/86 (63.95%) 
Recurrent Laryngeal nerve Palsy  1  0/83 (0.00%)  0/86 (0.00%)  1/86 (1.16%) 
Respiratory, thoracic and mediastinal disorders       
Pneumonitis  1  2/83 (2.41%)  2/86 (2.33%)  4/86 (4.65%) 
Indicates events were collected by systematic assessment
1
Term from vocabulary, CTCAE v4.0
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Heidi Roschitzki-Voser
Organization: International Breast Cancer Study Group (IBCSG)
Phone: +41 31 511 94 18
EMail: heidi.roschitzki@ibcsg.org
Layout table for additonal information
Responsible Party: International Breast Cancer Study Group
ClinicalTrials.gov Identifier: NCT01746225    
Other Study ID Numbers: IBCSG 42-12 / BIG 2-12
2012-003058-10 ( EudraCT Number )
First Submitted: November 28, 2012
First Posted: December 10, 2012
Results First Submitted: August 24, 2018
Results First Posted: March 27, 2020
Last Update Posted: March 27, 2020