Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer

Phase 2CompletedNCT00193063

SCRI Development Innovations, LLC41 enrolled

Overview

Due to its remarkable activity as salvage treatment in women with metastatic breast cancer as well as the additive activity observed for gemcitabine administered in combination with trastuzumab, the clinical activity of the combination of gemcitabine administered with trastuzumab represents an exciting and ideal combination to further evaluate in Her 2 over-expressing metastatic breast cancer patients.

Upon determination of eligibility, all patients will be receive: Gemcitabine + Trastuzumab

Study Type

INTERVENTIONAL

Allocation

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Breast Cancer

Interventions

TrastuzumabDRUG

Trastuzumab

GemcitabineDRUG

Gemcitabine

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: To be included in this study, you must meet the following criteria: * Her-2 positive metastatic breast cancer confirmed by biopsy * Measurable disease * Able to perform activities of daily living without considerable * No previous chemotherapy with gemcitabine * No more than one prior chemotherapy regimen for metastatic breast cancer * Adequate bone marrow, liver and renal function * Normal heart function * Give written informed consent prior to entering this study. Exclusion Criteria: You cannot participate in this study if any of the following apply to you: * Received previous treatment with gemcitabine * History of brain metastases * Serious underlying medical conditions 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.

Outcomes

Primary Outcomes

Overall Response Rate (ORR)

The Percentage of Patients Who Experience an Objective Benefit From Treatment. Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI or CT: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

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. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.

Time frame: 21 Months

Overall Survival (OS)

The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death

Time frame: 24 months

Data from ClinicalTrials.gov

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