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

This study has been completed.
Sponsor:
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
  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:


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
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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
Breast Diseases
Neoplasms
Neoplasms by Site
Skin Diseases
Doxorubicin
Gemcitabine
Liposomal doxorubicin
Paclitaxel
Anti-Infective Agents
Antibiotics, Antineoplastic
Antimetabolites
Antimetabolites, Antineoplastic
Antimitotic Agents
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Antiviral Agents
Enzyme Inhibitors
Immunologic Factors
Immunosuppressive Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Physiological Effects of Drugs
Radiation-Sensitizing Agents
Therapeutic Uses
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Tubulin Modulators

ClinicalTrials.gov processed this record on November 25, 2014