NCT00274456

Brief Summary

This was an open-label study conducted comparing the toxicity and antitumor activity of ABI-007 (Abraxane®, nab®-paclitaxel) to docetaxel (Taxotere).

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
302

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Nov 2005

Longer than P75 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2005

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

January 10, 2006

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 11, 2006

Completed
2.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2008

Completed
3.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

July 1, 2011

Completed
2 years until next milestone

Results Posted

Study results publicly available

July 2, 2013

Completed
Last Updated

November 21, 2019

Status Verified

November 1, 2019

Enrollment Period

2.3 years

First QC Date

January 10, 2006

Results QC Date

February 7, 2011

Last Update Submit

November 7, 2019

Conditions

Metastatic Breast Cancer

Keywords

Metastatic breast cancer, nab paclitaxel, docetaxel,

Outcome Measures

Primary Outcomes (1)

  • Percentage of Participants Showing an Overall Response As Assessed by the Independent Radiology Reader and by the Investigator

    Percentage of participants who achieve an objective confirmed complete or partial overall response based on Response Evaluation Criteria in Solid Tumors (RECIST) version 1.0. A complete response (CR) is the disappearance of all known disease and no new sites or disease related symptoms. A partial response (PR) is \>= 30% decrease in the sum of the longest diameters of target lesion. PR was also recorded when all measurable disease has completely disappeared, but a non-measurable component (ie, ascites) is still present but not progressing. Overall response (ORR) = CR+PR.

    Day 1 up to 95 weeks

Secondary Outcomes (6)

  • Percentage of Participants With Stable Disease for ≥ 16 Weeks, or Complete or Partial Overall Response

    Day 1 up to 95 weeks

  • Kaplan-Meier Estimates for Progression-free Survival (PFS)

    Day 1 up to 95 weeks

  • Kaplan-Meier Estimates for Duration of Response Based on Independent Radiology Assessment of Response and Progression

    Day 1 - 95 weeks

  • Kaplan-Meier Estimates for Duration of Response Based on Investigator Assessment of Response and Progression

    Day 1 - 95 weeks

  • Kaplan-Meier Estimate for Overall Survival (OS)

    Day 1 to 221 weeks

  • +1 more secondary outcomes

Other Outcomes (2)

  • Nadir of Myelosuppression (Over All Cycles) as Measured by Absolute Neutrophils (ANC), White Blood Cells (WBC) and Platelet Counts

    Day 1 up to 125 weeks

  • Nadir of Myelosuppression (Over All Cycles) as Measured by Hemoglobin (Hb) Counts

    Day 1 up to 125 weeks

Study Arms (4)

ABI-007 300 mg/m^2 q3w

EXPERIMENTAL

ABI-007 300 mg/m\^2 administered once every third week (q3w).

Drug: ABI-007

ABI-007 100 mg/m^2 weekly

EXPERIMENTAL

ABI-007 100 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest

Drug: ABI-007

ABI-007 150 mg/m^2 weekly

EXPERIMENTAL

ABI-007 150 mg/m\^2 once weekly for 3 weeks followed by 1 week of rest

Drug: ABI-007

Docetaxel 100 mg/m^2, q3w

ACTIVE COMPARATOR

Docetaxel (Taxotere) 100 mg/m\^2 administered once every third week (q3w).

Drug: Docetaxel

Interventions

ABI-007DRUG

ABI-007 administered by intravenous infusion over 30 minutes at one of three different dosing levels (100, 150 or 300 mg/m\^2) with a treatment cycle length of either 3 or 4 weeks depending upon treatment arm assignment.

Also known as: Abraxane®, nab®-paclitaxel
ABI-007 100 mg/m^2 weeklyABI-007 150 mg/m^2 weeklyABI-007 300 mg/m^2 q3w
DocetaxelDRUG

Docetaxel dosed q3w at 100 mg/m\^2

Also known as: Taxotere
Docetaxel 100 mg/m^2, q3w

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients had to meet the following criteria to be eligible for the study:
  • Pathologically confirmed adenocarcinoma of the breast.
  • No prior chemotherapy for metastatic breast cancer.
  • Stage IV disease.
  • Measurable disease (must have been ≥ 2.0 cm, except for pulmonary lesions that were well documented on CT scan that were ≥ 1.0 cm).
  • At least 3 weeks since prior cytotoxic chemotherapy (patients should have recovered from all acute effects of such therapy.
  • At least 4 weeks since radiotherapy, with full recovery. The measurable disease was completely outside the radiation portal or there was radiologic or clinical exam proof of progressive disease within the radiation portal.
  • At least 4 weeks since major surgery, with full recovery.
  • Eastern Cooperative Oncology Group (ECOG) performance status 0-2.
  • Age ≥18 years.
  • Patient had the following blood counts at Baseline:
  • Absolute neutrophil count (ANC) ≥1.5\*10\^9 cells/L
  • Platelets ≥100\*10\^9 cells/L
  • Hemoglobin (Hgb) ≥9 g/dL.
  • Patient had the following baseline blood chemistry levels:
  • +8 more criteria

You may not qualify if:

  • Patients who met any of the following criteria were excluded from the study:
  • Prior neo-adjuvant or adjuvant chemotherapy was allowed. No prior chemotherapy for metastatic disease was allowed. If a taxane was part of the adjuvant regimen, at least one year should have transpired since completion of taxane regimen.
  • Cumulative life-time dose of doxorubicin \>360 mg/m\^2. Doxorubicin was allowed as prior neo-adjuvant or adjuvant therapy but not for metastatic disease.
  • Concurrent immunotherapy or hormonal therapy for breast cancer.
  • Parenchymal brain metastases, unless documented to be clinically and radiographically stable for at least 6 months after treatment.
  • Serious intercurrent medical or psychiatric illness, including serious active infection.
  • History of class II-IV congestive heart failure.
  • History of other malignancy within the last 5 years which could affect the diagnosis or assessment of breast cancer.
  • Patients who had received an investigational drug within the previous 3 weeks.
  • Patient was enrolled in a different clinical study in which investigational procedures were performed or investigational therapies were administered. Also, a patient was not permitted enroll in such clinical trials while participating in this study.
  • Pregnant or nursing women
  • Patients with prior hypersensitivity to either Taxol or Taxotere.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Study Sites in Russia and the Ukraine

Kiev, 01021, Ukraine

Location

Related Publications (3)

  • O'Shaughnessy J, Gradishar WJ, Bhar P, Iglesias J. Nab-paclitaxel for first-line treatment of patients with metastatic breast cancer and poor prognostic factors: a retrospective analysis. Breast Cancer Res Treat. 2013 Apr;138(3):829-37. doi: 10.1007/s10549-013-2447-8. Epub 2013 Apr 6.

    PMID: 23563958BACKGROUND

  • Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P. Significantly longer progression-free survival with nab-paclitaxel compared with docetaxel as first-line therapy for metastatic breast cancer. J Clin Oncol. 2009 Aug 1;27(22):3611-9. doi: 10.1200/JCO.2008.18.5397. Epub 2009 May 26.

    PMID: 19470941RESULT

  • Gradishar WJ, Krasnojon D, Cheporov S, Makhson AN, Manikhas GM, Clawson A, Bhar P, McGuire JR, Iglesias J. Phase II trial of nab-paclitaxel compared with docetaxel as first-line chemotherapy in patients with metastatic breast cancer: final analysis of overall survival. Clin Breast Cancer. 2012 Oct;12(5):313-21. doi: 10.1016/j.clbc.2012.05.001. Epub 2012 Jun 23.

    PMID: 22728026RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Albumin-Bound PaclitaxelDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

PaclitaxelTaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenesAlbuminsProteinsAmino Acids, Peptides, and Proteins

Results Point of Contact

Title
Associate Director, Clinical Trials Disclosure
Organization
Celgene Corporation
clinicaltrialdisclosure@celgene.com
1-888-260-1599

Study Officials

  • Jose Iglesias, MD

    Abraxis BioScience, LLC, a wholly owned subsidiary of Celgene Corporation

    STUDY CHAIR

Publication Agreements

PI is Sponsor Employee
No
Restriction Type
OTHER
Restrictive Agreement
Yes

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

January 10, 2006

First Posted

January 11, 2006

Study Start

November 1, 2005

Primary Completion

March 1, 2008

Study Completion

July 1, 2011

Last Updated

November 21, 2019

Results First Posted

July 2, 2013

Record last verified: 2019-11

Locations

UA(1)