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 |
|---|---|---|---|---|---|---|---|---|---|---|---|
| NCT04425018 | MARGetuximab Or Trastuzumab (MARGOT) | PHASE2 | ACTIVE NOT_RECRUITING | 174 | — | — | Jul 13, 2020 | Jul 1, 2027 | Nov 18, 2025 | 14 | United States |
Compare the percentage of pathologic complete response (pCR) between patients treated with neoadjuvant TMP versus THP. Subject was considered a pCR responder if they achieved RCB 0 (no residual disease at surgery) and did not receive any additional non-protocol neoadjuvant treatment. Subject was considered a pCR non-responder if they did not achieve RCB 0 (RCB I, II, or III, or did not receive surgery) or if they received additional non-protocol neoadjuvant therapy. RCB is used to assess the response to neoadjuvant chemotherapy in breast cancer patients and is in a scale of 0 to 3, defined using established guidelines (Symmans et al. JCO 2007; M.D Anderson http://www.mdanderson.org/breastcancer\_RCB). Higher RCB score indicates more tumor burden remaining, thus worse outcome. RCB in this trial was determined according to local pathology review.
| Arm | Type | Description |
|---|---|---|
| Paclitaxel + Pertuzumab + Margetuximab | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days * Paclitaxel- via IV, Day 1,8,15 of each cycle * Margetuximab via IV, Day 1 of each cycle * Pertuzumab via IV, Day 1 of each cycle |
| Paclitaxel + Pertuzumab + Trastuzumab | EXPERIMENTAL | The research study procedures include screening for eligibility and study treatment including laboratory evaluations, two mandatory research biopsies and follow up visits.Cycle=21 days * Paclitaxel- via IV, Day 1,8,15 of each cycle * Pertuzumab via IV, Day 1 of each cycle * Trastuzumab via IV, Day 1 of each cycle |
| Name | Type | Description |
|---|---|---|
| Paclitaxel | DRUG | Pre-determined dose administered via IV, Day 1,8,15 of each cycle 4 study cycles, or 12 weeks. |
| Pertuzumab | DRUG | Pre-determined dose administered via IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. |
| Margetuximab | DRUG | Pre-determined dose administered by IV - Day 1 of each 21- day cycle 4 study cycles, or 12 weeks. |
| Trastuzumab | DRUG | Pre-determined dose administered via IV Day 1 of each 21- day cycle for 4 study cycles, or 12 weeks. |
Inclusion Criteria: * Stage II or III (according to AJCC cancer staging manual anatomic staging table, 8th edition) histologically confirmed invasive carcinoma of the breast. A minimum tumor size of 1.5 cm (in breast mass or axillary lymph node) determined by physical exam or imaging (whichever is ...