Doxorubicin HCI Liposome Injection Versus Weekly Docetaxel in Patients First Relapse Metastatic Breast Cancer

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Docetaxel

Drug: Liposomal Doxorubicin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193037

SCRI BRE 43

Details and patient eligibility

About

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.

Full description

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.

Enrollment

102 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

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.