Clinical trial NCT00193076: Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Official title: A Phase II Trial of Combination Gemcitabine, Carboplatin With or Without Trastuzumab in Patients With Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Lead sponsor: SCRI Development Innovations, LLC
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Genentech, Inc.
First posted: 2005-09-19
Enrollment: 96
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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

Eligibility criteria: 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.

Primary outcomes:
measure: Overall response rates
timeFrame: 18 Months
Secondary outcomes:
Other outcomes:
Locations:
city: Nashville
country: United States
facility: Tennessee Oncology
state: Tennessee
Study officials:
affiliation: SCRI Development Innovations, LLC
name: Denise A. Yardley, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Yardley DA, Burris HA 3rd, Simons L, Spigel DR, Greco FA, Barton JH, Shipley D, Drosick D, Hainsworth JD. A phase II trial of gemcitabine/carboplatin with or without trastuzumab in the first-line treatment of patients with metastatic breast cancer. Clin Breast Cancer. 2008 Oct;8(5):425-31. doi: 10.3816/CBC.2008.n.051.