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A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

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Trial Information

A Phase II Randomized Crossover Study Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer


Upon determination of eligibility, patients will be randomly assigned to one of two
treatment arms:

- Liposomal Doxorubicin

- Docetaxel

For ever 2 patients treated, 1 will receive treatment A (Liposomal Doxorubicin) and 1 will
receive treatment B (Docetaxel). Patients demonstrating progression on either ARM will be
eligible for cross over to treatment in the other ARM, provided patient still meets the
eligibility laboratory and performance status criteria. The study is not blinded so both the
patient and the doctor will know which treatment has been assigned.


Inclusion Criteria:



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

Exclusion Criteria:

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.

Please note: There are additional inclusion/exclusion criteria. The study center will
determine if you meet all of the criteria. If you do not qualify for the trial, study
personnel will explain the reasons. If you do qualify, study personnel will explain the
trial in detail and answer any questions you may have.

Type of Study:

Interventional

Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Overall survival

Outcome Time Frame:

18 Months

Safety Issue:

No

Principal Investigator

Denise A. Yardley, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Sarah Cannon Research Institute

Authority:

United States: Institutional Review Board

Study ID:

SCRI BRE 43

NCT ID:

NCT00193037

Start Date:

February 2001

Completion Date:

November 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location
Tennessee Oncology Nashville, Tennessee  37203