Approval Probability 71%
TA Base Rate26%
Adjusted LOA41%
ML RiskLOW_RISK
| NCT ID | Title | Phase | Status | Enrollment | Velocity | Design | Start | Completion | Last Updated | Sites | Countries |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00128856 | Gemcitabine, Doxorubicin and Paclitaxel (GAT) as Neoadjuvant Treatment of Breast Cancer Patients | PHASE2 | COMPLETED | 46 | — | — | Mar 1, 2003 | Jan 1, 2015 | Mar 6, 2023 | 10 | Spain |
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.
| Arm | Type | Description |
|---|---|---|
| Gemcitabine + Adriamycine + Paclitaxel | EXPERIMENTAL | 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. |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | - |
| Adriamycine | DRUG | - |
| Paclitaxel | DRUG | - |
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, ho...