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Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-Doxorubicin-Paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer


Phase 2
18 Years
75 Years
Not Enrolling
Female
Breast Cancer

Thank you

Trial Information

Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-Doxorubicin-Paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer


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%.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Pathological response rate

Principal Investigator

Antonio Antón, Md., PhD.

Investigator Role:

Study Chair

Investigator Affiliation:

Spanish Breast Cancer Research Group (GEICAM)

Authority:

Spain: Spanish Agency of Medicines

Study ID:

GEICAM 2002-01

NCT ID:

NCT00128856

Start Date:

December 2002

Completion Date:

August 2005

Related Keywords:

  • Breast Cancer
  • Neoadjuvant chemotherapy.
  • Stage III disease.
  • Breast Neoplasms

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