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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00128856
• Other study ID #: GEICAM 2002-01
• Status: Completed
• Phase: Phase 2
• Start date: March 2003
• Est. completion date: January 2015

Study information

• Verified date: March 2023
• Source: Spanish Breast Cancer Research Group
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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%.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: January 2015
• Est. primary completion date: January 2015
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• Gemcitabine

• Adriamycine

• Paclitaxel

Locations

Country	Name	City	State
Spain	Complejo Hospitalario Unviesitario A Coruña	A Coruña
Spain	Hospital Universitario Fundación Alcorcón	Alcorcón	Madrid
Spain	Hospital Infanta Cristina	Badajoz
Spain	Hospital Universitario Germans Trias i Pujol	Badalona	Barcelona
Spain	Complejo Hospitalario de Jaén	Jaén
Spain	Hospital Universitario La Princesa	Madrid
Spain	Hospital Universitario Ramón y Cajal	Madrid
Spain	Hospital Universitario Marqués de Valdecilla	Santander	Cantabria
Spain	Hospital General Universitario de Valencia	Valencia
Spain	Hospital Universitario Miguel Servet	Zaragoza

Sponsors (3)

Lead Sponsor	Collaborator
Spanish Breast Cancer Research Group	Bristol-Myers Squibb, Eli Lilly and Company

Country where clinical trial is conducted

Spain, 

References & Publications (1)

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 — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Pathological complete response (pCR) rate	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.	Up to week 15
Secondary	Overall response rate (ORR)	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.	Up to week 12
Secondary	Conservative surgery rate	To determine the percentage of conservative surgery rate versus other surgery	Up to week 15
Secondary	The Number of Participants Who Experienced Adverse Events (AE)	According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0	Through study treatment up to surgery
Secondary	Disease-free survival	Time from the start of treatment to the progression of the disease (if it happens)	Up to 5 years since surgery
Secondary	Tissue molecular markers and their correlation with response	Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment.	Up to week 15

External Links

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