NCT00193076

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
96

participants targeted

Target at P50-P75 for phase_2 breast-cancer

Timeline
Completed

Started Nov 2003

Typical duration for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 1, 2003

Completed
1.9 years until next milestone

First Submitted

Initial submission to the registry

September 12, 2005

Completed
7 days until next milestone

First Posted

Study publicly available on registry

September 19, 2005

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 1, 2006

Completed
2.4 years until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2008

Completed
Last Updated

May 3, 2011

Status Verified

May 1, 2011

Enrollment Period

2.5 years

First QC Date

September 12, 2005

Last Update Submit

May 2, 2011

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Overall response rates

    18 Months

Interventions

GemcitabineDRUG

Gemcitabine

CarboplatinDRUG

Carboplatin

TrastuzumabDRUG

Trastuzumab

Eligibility Criteria

Age18 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Tennessee Oncology

Nashville, Tennessee, 37203, United States

Location

Related Publications (1)

  • 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.

    PMID: 18952556RESULT

Related Links

MeSH Terms

Conditions

Breast Neoplasms

Interventions

GemcitabineCarboplatinTrastuzumab

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Heterocyclic CompoundsDeoxycytidineCytidinePyrimidine NucleosidesPyrimidinesHeterocyclic Compounds, 1-RingCoordination ComplexesOrganic ChemicalsAntibodies, Monoclonal, HumanizedAntibodies, MonoclonalAntibodiesImmunoglobulinsImmunoproteinsBlood ProteinsProteinsAmino Acids, Peptides, and ProteinsSerum GlobulinsGlobulins

Study Officials

  • Denise A. Yardley, MD

    SCRI Development Innovations, LLC

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER

Study Record Dates

First Submitted

September 12, 2005

First Posted

September 19, 2005

Study Start

November 1, 2003

Primary Completion

May 1, 2006

Study Completion

October 1, 2008

Last Updated

May 3, 2011

Record last verified: 2011-05

Locations

US(1)