Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer

Status

Completed

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT00193076

Enrollment

Registered

2005-09-19

Start date

2003-11-30

Completion date

2008-10-31

Last updated

2011-05-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

Brief summary

Pre-clinical data suggests that combination therapy with gemcitabine and carboplatin is synergistic, and both drugs may be synergistic with trastuzumab. Additionally, recent clinical data suggest that the combination of gemcitabine with platinum is an active regimen in metastatic breast cancer. This study will test the combination of gemcitabine with carboplatin in patients with metastatic breast cancer. Patients with Her2/neu overexpression will be stratified to receive trastuzumab in addition to gemcitabine and carboplatin.

Detailed description

Upon determination of eligibility, all patients will receive the following treatment: Gemcitabine + Carboplatin

Interventions

DRUGGemcitabine

Gemcitabine

DRUGCarboplatin

Carboplatin

DRUGTrastuzumab

Trastuzumab

Study design

Allocation

NON_RANDOMIZED

Intervention model

SINGLE_GROUP

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

To be included in this study, you must meet the following criteria: * Locally advanced or metastatic breast cancer * Measurable disease as per RECIST criteria * No prior chemotherapy in the metastatic breast setting * Prior chemotherapy and/or hormonal therapy for early stage breast cancer * Adjuvant Herceptin is allowed * Prior radiation therapy in either the metastatic or early stage setting * Patients may have received any number of hormonal therapies * Age \>18 years * Only women are eligible for the study * Able to perform activities of daily living with minimal assistance * Normal organ and bone marrow function * Patients who will be receiving Trastuzumab must have normal heart function * Sign a written informed consent document

Exclusion criteria

You cannot participate in this study if any of the following apply to you: * Received prior chemotherapy for metastatic breast cancer * Known leptomeningeal carcinomatosis * Uncontrolled brain metastasis * Uncontrolled intercurrent illness * Pregnant or lactating * History of other non-breast cancer malignancy * Received prior chemotherapy for early stage breast cancer within 6 months Please note: There are additional inclusion/

Design outcomes

Primary

Measure	Time frame
Overall response rates	18 Months

Countries

United States

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026