NCT00193037

Brief Summary

The efficacy of single agent liposomal doxorubicin as compared to single agent docetaxel will be evaluated as first line treatment in metastatic breast cancer patients, with subsequent crossover to the opposite arm at disease progression or patient intolerance. We will explore this as well as any possible cross resistance between these two agents.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
102

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Feb 2001

Longer than P75 for phase_2 breast-cancer

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

February 1, 2001

Completed
4.6 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
3.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed
11 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2009

Completed
3.7 years until next milestone

Results Posted

Study results publicly available

July 19, 2013

Completed
Last Updated

July 31, 2013

Status Verified

July 1, 2013

Enrollment Period

7.8 years

First QC Date

September 12, 2005

Results QC Date

August 22, 2012

Last Update Submit

July 24, 2013

Conditions

Breast Cancer

Keywords

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment

    ORR is defined as the percentage of patients who exhibit a Complete Response (CR) or Partial Response (PR). Complete Response is the total disappearance of clinically and radiologically detectable disease for at least 4 weeks. Partial Response is at least a 50% reduction of all measurable lesions as measured by the product of the perpendicular diameters of the greatest dimensions of tumor size, with no new lesions appearing for at least four weeks.

    18 Months

Secondary Outcomes (1)

  • Progression Free Survival (PFS), the Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Worsening of Their Disease.

    18 Months

Study Arms (2)

Liposomal Doxorubicin

EXPERIMENTAL

Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days.

Drug: Liposomal Doxorubicin

Docetaxel

EXPERIMENTAL

Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle

Drug: Docetaxel

Interventions

Liposomal DoxorubicinDRUG

Liposomal Doxorubicin

Also known as: Doxil
Liposomal Doxorubicin
DocetaxelDRUG

Docetaxel

Also known as: Taxotere
Docetaxel

Eligibility Criteria

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

You may qualify if:

  • To be included in this study, you must meet the following criteria:
  • Metastatic breast cancer confirmed by biopsy
  • Prior adjuvant/neoadjuvant treatment allowed
  • Measurable disease
  • Able to perform activities of daily living with minimal assistance
  • Age 18 years or older
  • Adequate bone marrow, liver and kidney function
  • Normal heart function
  • Written informed consent

You may not qualify if:

  • You cannot participate in this study if any of the following apply to you:
  • Pre-existing moderate peripheral neuropathy
  • History of significant heart disease
  • Meningeal metastases.
  • Prior chemotherapy for metastatic breast cancer
  • No measurable disease (including bone only, pleural effusions, etc.)
  • Receiving Herceptin therapy.
  • Women who are pregnant or lactating.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • Yardley DA, Burris HA 3rd, Spigel DR, Clark BL, Vazquez E, Shipley D, Barton J, Thompson D, Montes I, Greco FA, Hainsworth JD. A phase II randomized crossover study of liposomal doxorubicin versus weekly docetaxel in the first-line treatment of women with metastatic breast cancer. Clin Breast Cancer. 2009 Nov;9(4):247-52. doi: 10.3816/CBC.2009.n.042.

    PMID: 19933081RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

liposomal doxorubicinDocetaxel

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

TaxoidsCyclodecanesCycloparaffinsHydrocarbons, AlicyclicHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsDiterpenesTerpenes

Results Point of Contact

Title
John D. Hainsworth, MD
Organization
Sarah Cannon Research Institute
jhainsworth@tnonc.com
615-329-7274

Study Officials

  • Denise A. Yardley, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

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
CROSSOVER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

February 1, 2001

Primary Completion

December 1, 2008

Study Completion

November 1, 2009

Last Updated

July 31, 2013

Results First Posted

July 19, 2013

Record last verified: 2013-07

Locations

US(1)