Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients

NCT ID: NCT00128856

Last Updated: 2023-03-06

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE2
• Total Enrollment: 46 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2003-03-31
• Study Completion Date: 2015-01-31

Brief Summary

This is a multicenter, open-label, phase II trial to assess the efficacy of the GAT neoadjuvant regimen in patients with stage III breast cancer.

Detailed Description

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%.

Conditions

Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

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.

Group Type: EXPERIMENTAL

Gemcitabine

Intervention Type: DRUG

Adriamycine

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Interventions

Gemcitabine

Intervention Type: DRUG

Adriamycine

Intervention Type: DRUG

Paclitaxel

Intervention Type: DRUG

Other Intervention Names

Gemzar; doxorubicin; Taxol

Eligibility Criteria

Inclusion Criteria

• Stage III breast cancer disease, with histological confirmation by true-cut or open-biopsy.
• Ages between 18 and 75 years old. Patients older than 70 must have an adequate quality of life to be eligible.
• Patients cannot have received previous treatment with chemotherapy, hormone therapy, radiotherapy or immune therapy.
• Performance status of 0,1, 2 Eastern Cooperative Oncology Group (ECOG).
• At least a 6 month life expectancy.
• Neutrophils > 1500; platelets > 100000; haemoglobin > 10 mg/dL.
• Adequate renal and hepatic functions, with serum creatinine < 1.2 mg/dl and total bilirubin < 2 mg/dl.
• Adequate contraceptive methods during the study and up to 3 months after.
• Adequate cardiac function assessed by physical exam, electrocardiogram and left ventricular ejection fraction > 55%.

Exclusion Criteria

• Inflammatory carcinoma or stage I, II or IV breast cancer disease.
• Males.
• Active infection.
• Other neoplasms except for basal skin carcinoma or cervical in situ carcinoma adequately treated. Other previous neoplasms are allowed if diagnosed and treated more than 5 years before study registration.
• Concomitant serious disease provoking organ failure (heart, renal, hepatic, respiratory).
• Pre-existing motor or sensorial neuropathy > grade 1.
• Inability for treatment compliance.
• History of hypersensitivity to compounds such as cremophor, cyclosporine or vitamin K.
• History of arrhythmias or congestive heart failure, even when controlled; or active cardiac blocking of second or third grade.
• History of myocardial infarction in the previous 6 months.
• Hypertension not controlled.
• Pregnant or lactating women.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Eli Lilly and Company

INDUSTRY

Sponsor Role: collaborator

Bristol-Myers Squibb

INDUSTRY

Sponsor Role: collaborator

Spanish Breast Cancer Research Group

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Study Director

Role: STUDY_DIRECTOR

Hospital Miguel Servet

Study Director

Role: STUDY_DIRECTOR

Complejo Hospitalrio de Jaén

Locations

Hospital Universitario Germans Trias i Pujol

Badalona, Barcelona, Spain

Hospital Universitario Marqués de Valdecilla

Santander, Cantabria, Spain

Hospital Universitario Fundación Alcorcón

Alcorcón, Madrid, Spain

Complejo Hospitalario Unviesitario A Coruña

A Coruña, , Spain

Hospital Infanta Cristina

Badajoz, , Spain

Complejo Hospitalario de Jaén

Jaén, , Spain

Hospital Universitario La Princesa

Madrid, , Spain

Hospital Universitario Ramón y Cajal

Madrid, , Spain

Hospital General Universitario de Valencia

Valencia, , Spain

Hospital Universitario Miguel Servet

Zaragoza, , Spain

Countries

Spain

References

Sanchez-Rovira P, Anton A, Barnadas A, Velasco A, Lomas M, Rodriguez-Pinilla M, Ramirez JL, Ramirez C, Rios MJ, Castella E, Garcia-Andrade C, San Antonio B, Carrasco E, Palacios JL. Classical markers like ER and ki-67, but also survivin and pERK, could be involved in the pathological response to gemcitabine, adriamycin and paclitaxel (GAT) in locally advanced breast cancer patients: results from the GEICAM/2002-01 phase II study. Clin Transl Oncol. 2012 Jun;14(6):430-6. doi: 10.1007/s12094-012-0820-4.

Reference Type: RESULT

PMID: 22634531 (View on PubMed)

Related Links

http://www.geicam.org

Description Spanish Breast Cancer Research Group (GEICAM) is a Spanish Breast Cancer Research Group

Other Identifiers

GEICAM 2002-01

Identifier Type: -

Identifier Source: org_study_id