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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT00128856
Recruitment Status : Completed
First Posted : August 10, 2005
Last Update Posted : December 14, 2018
Sponsor:
Collaborators:
Eli Lilly and Company
Bristol-Myers Squibb
Information provided by (Responsible Party):
Spanish Breast Cancer Research Group

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.

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Gemcitabine Drug: Adriamycine Drug: Paclitaxel Phase 2

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%.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 46 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : March 2003
Actual Primary Completion Date : January 2015
Actual Study Completion Date : January 2015


Arm Intervention/treatment
Experimental: 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.
Drug: Gemcitabine
Other Name: Gemzar

Drug: Adriamycine
Other Name: doxorubicin

Drug: Paclitaxel
Other Name: Taxol




Primary Outcome Measures :
  1. Pathological complete response (pCR) rate [ Time Frame: Up to week 15 ]
    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.


Secondary Outcome Measures :
  1. Overall response rate (ORR) [ Time Frame: Up to week 12 ]
    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.

  2. Conservative surgery rate [ Time Frame: Up to week 15 ]
    To determine the percentage of conservative surgery rate versus other surgery

  3. The Number of Participants Who Experienced Adverse Events (AE) [ Time Frame: Through study treatment up to surgery ]
    According to the Common Terminology Criteria for Adverse Events (CTCAE) version 2.0

  4. Disease-free survival [ Time Frame: Up to 5 years since surgery ]
    Time from the start of treatment to the progression of the disease (if it happens)

  5. Tissue molecular markers and their correlation with response [ Time Frame: Up to week 15 ]
    Evaluation of changes in the tumor marker profile before and after treatment in tumor samples obtained before and after chemotherapy treatment.



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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes 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 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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00128856


Locations
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Spain
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
Hospital Universitario Marqués de Valdecilla
Santander, Cantabria, Spain, 39008
Hospital Universitario Fundación Alcorcón
Alcorcón, Madrid, Spain, 28922
Complejo Hospitalario Unviesitario A Coruña
A Coruña, Spain, 15006
Hospital Infanta Cristina
Badajoz, Spain, 06080
Complejo Hospitalario de Jaén
Jaén, Spain, 23007
Hospital Universitario La Princesa
Madrid, Spain, 28006
Hospital Universitario Ramón y Cajal
Madrid, Spain, 28034
Hospital General Universitario de Valencia
Valencia, Spain, 46014
Hospital Universitario Miguel Servet
Zaragoza, Spain, 50009
Sponsors and Collaborators
Spanish Breast Cancer Research Group
Eli Lilly and Company
Bristol-Myers Squibb
Investigators
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Study Director: Study Director Hospital Universitario Miguel Servet
Study Director: Study Director Complejo Hospitalrio de Jaén

Additional Information:
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Responsible Party: Spanish Breast Cancer Research Group
ClinicalTrials.gov Identifier: NCT00128856    
Other Study ID Numbers: GEICAM 2002-01
First Posted: August 10, 2005    Key Record Dates
Last Update Posted: December 14, 2018
Last Verified: December 2018
Keywords provided by Spanish Breast Cancer Research Group:
Neoadjuvant chemotherapy.
Stage III disease.
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Gemcitabine
Paclitaxel
Albumin-Bound Paclitaxel
Doxorubicin
Liposomal doxorubicin
Antineoplastic Agents, Phytogenic
Antineoplastic Agents
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antimetabolites
Antiviral Agents
Anti-Infective Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors