Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
This study has been completed.
Sponsor:
Spanish Breast Cancer Research Group
Collaborators:
Eli Lilly and Company
Bristol-Myers Squibb
Information provided by:
Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier:
NCT00128856
First received: August 9, 2005
Last updated: August 29, 2005
Last verified: August 2005
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Purpose
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, confirmed by true-cut or open biopsy.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: gemcitabine Drug: doxorubicin Drug: paclitaxel |
Phase 2 |
| Study Type: | Interventional |
| Study Design: | Allocation: Non-Randomized Endpoint Classification: Efficacy Study Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Doxorubicin
Doxorubicin hydrochloride
Paclitaxel
Gemcitabine
Gemcitabine hydrochloride
U.S. FDA Resources
Further study details as provided by Spanish Breast Cancer Research Group:
Primary Outcome Measures:
- Pathological response rate
Secondary Outcome Measures:
- Overall response rate (complete + partial responses)
- Conservative surgery rate
- Toxicity
- Disease-free survival
- Tissue molecular markers and correlation with response
- XPD single nucleotide polymorphisms (SNPs) and correlation with treatment response
| Estimated Enrollment: | 43 |
| Study Start Date: | December 2002 |
| Estimated Study Completion Date: | August 2005 |
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| Ages Eligible for Study: | 18 Years to 75 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
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 (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 (EKG) and left ventricular ejection fraction (LVEF) > 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 (HT) not controlled.
- Pregnant or lactating women.
Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00128856
Locations
| Spain | |
| Spanish Breast Cancer Research Group | |
| San Sebastián de los Reyes, Madrid, Spain, 28700 | |
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Eli Lilly and Company
Bristol-Myers Squibb
Investigators
| Study Chair: | Antonio Antón, Md., PhD. | Spanish Breast Cancer Research Group (GEICAM) |
| Study Chair: | Pedro Sánchez-Rovira, MD., PhD | Spanish Breast Cancer Research Group (GEICAM) |
More Information
Additional Information:
No publications provided
| ClinicalTrials.gov Identifier: | NCT00128856 History of Changes |
| Other Study ID Numbers: | GEICAM 2002-01 |
| Study First Received: | August 9, 2005 |
| Last Updated: | August 29, 2005 |
| Health Authority: | Spain: Spanish Agency of Medicines |
Keywords provided by Spanish Breast Cancer Research Group:
|
Neoadjuvant chemotherapy. Stage III disease. |
Additional relevant MeSH terms:
|
Breast Neoplasms Neoplasms by Site Neoplasms Breast Diseases Skin Diseases Doxorubicin Gemcitabine Paclitaxel Antibiotics, Antineoplastic Antineoplastic Agents Therapeutic Uses Pharmacologic Actions Antimetabolites, Antineoplastic |
Antimetabolites Molecular Mechanisms of Pharmacological Action Antiviral Agents Anti-Infective Agents Enzyme Inhibitors Immunosuppressive Agents Immunologic Factors Physiological Effects of Drugs Radiation-Sensitizing Agents Tubulin Modulators Antimitotic Agents Mitosis Modulators Antineoplastic Agents, Phytogenic |
ClinicalTrials.gov processed this record on May 16, 2013