Weekly Gemcitabine and Trastuzumab in the Treatment of Patients With Human Epidermal Growth Factor Receptor 2 (HER2) Positive Metastatic Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00193063|
Recruitment Status : Completed
First Posted : September 19, 2005
Results First Posted : March 12, 2014
Last Update Posted : March 12, 2014
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Trastuzumab Drug: Gemcitabine||Phase 2|
Upon determination of eligibility, all patients will be receive:
Gemcitabine + Trastuzumab
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Trial of Weekly Gemcitabine and Herceptin in the Treatment of Patients With HER-2 Overexpressing Metastatic Breast Cancer|
|Study Start Date :||July 2001|
|Actual Primary Completion Date :||May 2009|
|Actual Study Completion Date :||August 2009|
All patients entering this trial received treatment with a combination of gemcitabine and trastuzumab. Gemcitabine 1000 mg/m2 was administered intravenously on days 1, 8,and 15 of a 28-day cycle. Trastuzumab was administered as a 4 mg/kg intravenous loading dose on day 1 and subsequently at a dose of 2 mg/kg on a weekly basis.
Other Name: Herceptin
Other Name: Gemzar
- Overall Response Rate (ORR) [ Time Frame: 18 Months ]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.
- Progression Free Survival (PFS) [ Time Frame: 21 Months ]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.
- Overall Survival (OS) [ Time Frame: 24 months ]The Length of Time, in Months, That Patients Were Alive From Their First Date of Protocol Treatment Until Death
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00193063
|Principal Investigator:||Denise A. Yardley, MD||SCRI Development Innovations, LLC|