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

Phase 2CompletedNCT00193037

SCRI Development Innovations, LLC102 enrolled

Overview

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.

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

102

Conditions

Breast Cancer

Interventions

Liposomal DoxorubicinDRUG

Liposomal Doxorubicin

DocetaxelDRUG

Docetaxel

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

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.

Locations (1)

Tennessee Oncology

Nashville, Tennessee, United States

Outcomes

Primary Outcomes

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.

Time frame: 18 Months

Secondary Outcomes

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.

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.

Time frame: 18 Months

Data from ClinicalTrials.gov

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