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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT00193206 | Neo-adjuvant Gemcitabine, Epirubicin, ABI-007 (GEA) in Locally Advanced or Inflammatory Breast Cancer | PHASE2 | COMPLETED | 123 | — | — | Sep 1, 2005 | May 1, 2009 | Nov 23, 2021 | 13 | United States |
| NCT00193050 | Weekly Gemcitabine, Epirubicin, and Docetaxel in Locally Advanced or Inflammatory Breast Cancer | PHASE2 | COMPLETED | 110 | — | — | Nov 1, 2001 | Mar 1, 2009 | Oct 26, 2021 | - | — |
For the purpose of this study, a pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0) and axillary lymph nodes (pN0), gross or microscopic, in the sample removed at the time of surgical resection. Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
For the purpose of this study, a Pathologic complete response (pCR) was defined as no evidence of residual invasive tumor in the breast (pT0). Residual ductal or lobular carcinoma in situ was not considered in pCR assessments. Percentage of participants who experienced pCR is reported.
| Arm | Type | Description |
|---|---|---|
| Intervention | EXPERIMENTAL | Patients were treated with 6 doses of neoadjuvant gemcitabine 2000 mg/m2, epirubicin 50 mg/m2, and albumin-bound paclitaxel 175 mg/m2 intravenously administered at 14-day intervals. Following neoadjuvant chemotherapy, patients underwent either mastectomy or breast conservation surgery; pathologic response to treatment was assessed. Postoperatively, patients received 4 doses of gemcitabine 2000 mg/m2 with albumin-bound paclitaxel 220 mg/m2 at 14-day intervals. Pegfilgrastim 6 mg was administered subcutaneously on day 2 following each dose of chemotherapy. |
| Name | Type | Description |
|---|---|---|
| Gemcitabine | DRUG | Gemcitabine 2000 mg/m2 IV D1 q 14 days x 6 cycles |
| Epirubicin | DRUG | Epirubicin 50 mg/m2 D1 q 14 days x 6 cycles |
| Albumin-bound Paclitaxel | DRUG | ABI-007 175 mg/m2 D1 q 14 days x 6 cycles |
| Docetaxel | DRUG | Docetaxel |
Inclusion Criteria: To be included in this study, you must meet the following criteria: * Locally advanced/inflammatory adenocarcinoma of the breast * 18 years of age or older * Normal heart function * Able to perform activities of daily living with minimal assistance * No prior chemotherapy for b...