18 and older, female only, with Metastatic Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Percentage of Participants With Objective Confirmed Complete or Partial Overall Response According to Response Evaluation Criteria in Solid Tumors (RECIST) Version 1.0 Based on Investigator and Independent ReviewersPrimary· Every 8 weeks from study start until disease progression; Up to 61 months
Overall response rate (ORR) is complete response (CR) + partial response (PR). Complete response (CR): The disappearance of all known disease and no new sites or disease related symptoms confirmed at least 4 weeks after initial documentation. All sites must be assessed, including non-measurable sites, such as effusions, or markers. Disappearance of all non-target lesions. The normalization of tumor marker level confirmed at least 4 weeks after initial documentation. Partial response (PR): At least a 30% decrease in the sum of the longest diameters of target lesions, taking as a reference the b
Investigator Assessment
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
30
16.7 – 42.9
Abraxane (No Prior Taxane Therapy)
28
17.6 – 37.7
Independent Reviewer Assessment
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
32
18.6 – 45.2
Abraxane (No Prior Taxane Therapy)
32
21.1 – 42.0
Percentage of Participants With Disease ControlSecondary· Every 8 weeks from study start until disease progression; Up to 61 months
Disease control was defined as stable disease (SD) for ≥ 16 weeks or complete response (CR) or partial response (PR). Response was evaluated by the Investigator and by an independent reviewer using Response Evaluation Criteria in Solid Tumors (RECIST) guidelines version 1.0. See Outcome #1 for definitions of CR and PR. RECIST defines SD for target lesions as neither sufficient shrinkage to qualify for partial response nor sufficient increase to qualify for progressive disease, no occurrence of progression disease for non-target lesions, and no new lesions.
Investigator Assessment
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
51
36.8 – 65.4
Abraxane (No Prior Taxane Therapy)
57
45.4 – 67.7
Independent Reviewer Assessment
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
55
41.1 – 69.5
Abraxane (No Prior Taxane Therapy)
57
45.4 – 67.7
Progression-free Survival (PFS)Secondary· Study start until disease progression, death, or up to data cut off of 31 May 2013; up to 61 months
PFS was defined as the time from the first dose of study drug to the start of progression or patient death (any cause), whichever occurred first. Participants who did not have progression or did not die were censored at the last known time the participant was progression free. Participants who initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated.
Investigator Assessment
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
6.0
3.5 – 8.8
Abraxane (No Prior Taxane Therapy)
6.7
5.3 – 7.3
Independent Reviewer Assessment
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
5.3
3.3 – 7.3
Abraxane (No Prior Taxane Therapy)
5.3
3.5 – 6.6
Duration of Response Based on Independent Reviewer AssessmentSecondary· Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. CR and PR were defined in outcome #1. Progressive disea
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
10.9
7.3 – 18.9
Abraxane (No Prior Taxane Therapy)
9.2
7.4 – 14.2
Duration of Response Based on Investigator AssessmentSecondary· Initial response until disease progression; or until data cut off 31 May 2013; up to 61 months
Duration of response was defined as progression-free survival in responders, i.e. as the time between the start of a complete response (CR) or partial response (PR) and the start of progressive disease (PD) or patient death from any cause, whichever occurred first. Participants who did not have progression or had not died were censored at the last known time the participant was progression free. Participants who had initiated other anticancer therapy prior to progression were censored at the time when new anticancer therapy was initiated. Complete response (CR) and partial response (PR) were d
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
10.5
8.8 – 25.4
Abraxane (No Prior Taxane Therapy)
10.8
8.7 – 22.4
Patient SurvivalSecondary· Study start until death, or until data cut-off 31 May 2013; up to 61 months
Participant survival was the time from the first dose of study drug to participant death from any cause. Participants who did not die were censored at the last known time the participant was alive.
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
20.9
14.3 – 28.0
Abraxane (No Prior Taxane Therapy)
20.0
13.8 – 28.6
Number of Participants Experiencing Dose Reductions, Interruptions, or Dose Delays of Study DrugSecondary· Day 1 of study drug to Day 940; data cut off 31 May 2013
The number of participants with dose reductions, dose interruptions and dose delays that occurred during the treatment period. Dose reductions, interruptions and delays are typically caused by clinically significant laboratory abnormalities and /or treatment emergent adverse events/toxicities.
Patients with at Least One Dose Reduction
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
11
Abraxane (No Prior Taxane Therapy)
19
Patients with at Least One Dose Interruption
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
3
Abraxane (No Prior Taxane Therapy)
2
Patients with at Least One Dose Delay/Not Given
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
20
Abraxane (No Prior Taxane Therapy)
39
Number of Participants With Treatment-Emergent Adverse EventsSecondary· Day 1 to Day 940
Count of study participants who had at least one treatment-emergent adverse event (TEAE) defined as any adverse event that began or worsened in grade after the start of study drug through 30 days after the last dose of study drug. The National Cancer Institute (NCI)'s Common Terminology Criteria for AEs (CTCAE) was used to grade AE severity: severity grade 3= severe and undesirable AE. Severity grade 4= life-threatening or disabling AE. Severity grade 5 = death.
≥1 Adverse Event (AE)
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
46
Abraxane (No Prior Taxane Therapy)
75
≥1 Treatment related Adverse Event
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
41
Abraxane (No Prior Taxane Therapy)
74
≥ 1 Serious Adverse Event
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
5
Abraxane (No Prior Taxane Therapy)
14
Treatment related Serious Adverse Event
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
2
Abraxane (No Prior Taxane Therapy)
7
≥1 One Grade 3/4 Adverse Event
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
25
Abraxane (No Prior Taxane Therapy)
36
≥1 One Grade 3 or Higher Adverse Event
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
25
Abraxane (No Prior Taxane Therapy)
36
≥1 AE leading to treatment discontinuation
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
2
Abraxane (No Prior Taxane Therapy)
16
≥1 AE leading to death
Group
Value
95% CI
Abraxane (Prior Taxane Therapy)
0
Abraxane (No Prior Taxane Therapy)
2
Adverse events — posted to ClinicalTrials.gov
Time frame: Any Adverse Event (AE) that started after initial study drug administration through the end of the study or 30 days after the last treatment, whichever was later, were followed until the AE had resolved or stabilized. Upt to 61 months..
Reporting threshold: 5.0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
The purpose of this study is to determine the toxicity and anti-tumor activity of nab-paclitaxel 100mg/m\^2 administered weekly in a 4-week cycle as first line therapy to patients with metastatic breast cancer who received taxanes as part of their adjuvant therapy and patients who did not receive taxanes as part of their adjuvant therapy.
Publications & conference data
1 peer-reviewed publication reference this trial (live from Europe PMC):
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by Celgene
Last refreshed: 22 November 2019
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT00456846.