Clinical trial · Interventional
Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients
Phase II Pharmacogenomic and Clinical Trial for the Administration of Gemcitabine-doxorubicin-paclitaxel (GAT) as Neoadjuvant Treatment of Patients With Stage III Breast Cancer
NCT00128856CI-TRIAL-00064457completedPhase 2ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (3)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Adriamycine | Drug | — | UNRESOLVED |
| Gemcitabine | Drug | Gemcitabine | ALIAS |
| Paclitaxel | Drug | Paclitaxel | ALIAS |
Design
Arms and outcomes
Arms (1)
- type
- EXPERIMENTAL
- label
- Gemcitabine + Adriamycine + Paclitaxel
- description
- 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.
- interventionNames
- Drug: Gemcitabine
- Drug: Adriamycine
- Drug: Paclitaxel
Primary outcomes (1)
- measure
- Pathological complete response (pCR) rate
- timeFrame
- Up to week 15
- description
- 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 outcomes (5)
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
- Maximum age
- 75 Years
Show eligibility criteria text
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.
References
Publications (1)
- RESULTSanchez-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 involved in the pathological response to gemcitabine, adriamycin and paclitaxel (GAT) in locally advanced breast cancer patients: results from the GEICAM/2002-01 phase II study. Clin Transl Oncol. 2012 Jun;14(6):430-6. doi: 10.1007/s12094-012-0820-4. PMID 22634531