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

SCRI Development Innovations

Status and phase

Completed

Phase 2

Conditions

Breast Cancer

Treatments

Drug: Trastuzumab

Drug: Gemcitabine

Drug: Carboplatin

Study type

Interventional

Funder types

Other

Industry

Identifiers

NCT00193076

SCRI BRE 63

H3036S

B9E-US-S324

Details and patient eligibility

About

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.

Full description

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

Gemcitabine + Carboplatin

Enrollment

96 estimated patients

Sex

Female

Ages

18+ years old

Volunteers

No 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/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.