Clinical trial NCT00128856: Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Neoadjuvant chemotherapy.
Stage III disease.
Lead sponsor: Spanish Breast Cancer Research Group
Sponsor class: OTHER
Collaborators: name: Eli Lilly and Company
name: Bristol-Myers Squibb
First posted: 2005-08-10
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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%.

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.

Primary outcomes:
measure: Pathological complete response (pCR) rate
timeFrame: Up to week 15
Secondary outcomes:
measure: Overall response rate (ORR)
timeFrame: Up to week 12
measure: Conservative surgery rate
timeFrame: Up to week 15
measure: The Number of Participants Who Experienced Adverse Events (AE)
timeFrame: Through study treatment up to surgery
measure: Disease-free survival
timeFrame: Up to 5 years since surgery
measure: Tissue molecular markers and their correlation with response
timeFrame: Up to week 15
Other outcomes:
Locations:
city: Badalona
country: Spain
facility: Hospital Universitario Germans Trias i Pujol
state: Barcelona
city: Santander
country: Spain
facility: Hospital Universitario Marqués de Valdecilla
state: Cantabria
city: Alcorcón
country: Spain
facility: Hospital Universitario Fundación Alcorcón
state: Madrid
city: A Coruña
country: Spain
facility: Complejo Hospitalario Unviesitario A Coruña
city: Badajoz
country: Spain
facility: Hospital Infanta Cristina
city: Jaén
country: Spain
facility: Complejo Hospitalario de Jaén
city: Madrid
country: Spain
facility: Hospital Universitario La Princesa
city: Madrid
country: Spain
facility: Hospital Universitario Ramón y Cajal
city: Valencia
country: Spain
facility: Hospital General Universitario de Valencia
city: Zaragoza
country: Spain
facility: Hospital Universitario Miguel Servet
Study officials:
affiliation: Hospital Miguel Servet
name: Study Director
role: STUDY_DIRECTOR
affiliation: Complejo Hospitalrio de Jaén
name: Study Director
role: STUDY_DIRECTOR
References:
citation: 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.