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

Phase 2

Completed

Conditions: Breast Cancer

Interventions: Drug: Liposomal Doxorubicin
Drug: Docetaxel

Registration Number: NCT00193037

Lead Sponsor: SCRI Development Innovations, LLC

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.

Detailed 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.

Recruitment & Eligibility

Status: COMPLETED

Sex: All

Target Recruitment: 102

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.

Study & Design

Study Type: INTERVENTIONAL

Study Design: CROSSOVER

Arm && Interventions

Group	Intervention	Description
Liposomal Doxorubicin	Liposomal Doxorubicin	Liposomal doxorubicin 40 mg/m2 by 1 hour IV infusion repeated every 28 days.
Docetaxel	Docetaxel	Weekly docetaxel 36 mg/m2 by 30 minute IV infusion on days 1, 8, and 15 of the 28 day cycle

Primary Outcome Measures

Name	Time	Method
Overall Response Rate (ORR), the Percentage of Patients Who Experience an Objective Benefit From Treatment	18 Months	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.

Secondary Outcome Measures

Name	Time	Method
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	PFS was defined as the interval from first study treatment until the date that the first progression of breast cancer was documented, or death occurred.