Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00128856|
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : December 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Gemcitabine Drug: Adriamycine Drug: Paclitaxel||Phase 2|
2 treatment cycles of chemotherapy (one cycle = 2 weeks) must be administered to each patient before breast surgery.
The required number of patients has been calculated following Simon's method. 43 patients will be enrolled in two phases: first, 29 patients must be enrolled, and at least 2 pathological complete responses obtained. Patients recruitment will continue until 43 patients have been enrolled. Assumptions are that there is a 95% probability to obtain a rate of pathological complete responses of at least 10%.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||46 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer|
|Actual Study Start Date :||March 2003|
|Actual Primary Completion Date :||January 2015|
|Actual Study Completion Date :||January 2015|
Experimental: Gemcitabine + Adriamycine + Paclitaxel
Neoadjuvant chemotherapy consisted of adriamycine 40 mg/m2, administered on day 1 as an i.v. infusion. Paclitaxel 150 mg/m2 was administered on day 2 as an i.v infusion followed by gemcitabine 2000 mg/m2 as an i.v. infusion. The three drugs were administered every two weeks for 6 cycles.
Other Name: Gemzar
Other Name: doxorubicin
Other Name: Taxol
- Pathological complete response (pCR) rate [ Time Frame: Up to week 15 ]pCR is defined as no invasive cells identifiable in breast sections at surgery. Response will be measured by physical exam and breast imaging before surgery and will be evaluated according to the World Health Organization (WHO) criteria. Pathological response after surgery, will be based on the proportion of remaining tumor and post-chemotherapy changes, evaluating separately the response in the breast and in the axilla lymph nodes.
- Overall response rate (ORR) [ Time Frame: Up to week 12 ]Tumor response is defined as the percentage of patients with a complete or partial response out of the patients who had measurable disease at baseline.
- Conservative surgery rate [ Time Frame: Up to week 15 ]To determine the percentage of conservative surgery rate versus other surgery
- The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: Through study treatment up to surgery ]According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0
- Disease-free survival [ Time Frame: Up to 5 years since surgery ]Time from the start of treatment to the progression of the disease (if it happens)
- Tissue molecular markers and their correlation with response [ Time Frame: Up to week 15 ]Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment.
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): NCT00128856
|Hospital Universitario Germans Trias i Pujol|
|Badalona, Barcelona, Spain, 08916|
|Hospital Universitario Marqués de Valdecilla|
|Santander, Cantabria, Spain, 39008|
|Hospital Universitario Fundación Alcorcón|
|Alcorcón, Madrid, Spain, 28922|
|Complejo Hospitalario Unviesitario A Coruña|
|A Coruña, Spain, 15006|
|Hospital Infanta Cristina|
|Badajoz, Spain, 06080|
|Complejo Hospitalario de Jaén|
|Jaén, Spain, 23007|
|Hospital Universitario La Princesa|
|Madrid, Spain, 28006|
|Hospital Universitario Ramón y Cajal|
|Madrid, Spain, 28034|
|Hospital General Universitario de Valencia|
|Valencia, Spain, 46014|
|Hospital Universitario Miguel Servet|
|Zaragoza, Spain, 50009|
|Study Director:||Study Director||Hospital Universitario Miguel Servet|
|Study Director:||Study Director||Complejo Hospitalrio de Jaén|