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Post-operative treatment trastuzumab mono therapy · 1 trial · 2 indications
The experimental therapy would be rated as insufficiently active, if the observed pCR rate is 10 % or lower, as this corresponds to the expectations after chemotherapy alone. The experimental therapy would be considered to be a promising candidate for further development (e.g. in a phase III trial), if the true pCR rate amounted to 20% or more.
| Arm | Type | Description |
|---|---|---|
| 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| 5-FU, leucovorin, docetaxel, oxaliplatin (FLOT), trastuzumab | DRUG | Pre-operative treatment 4 cycles and post-operative treatment 4 cycles: Trastuzumab 4 mg/kg BW (6 mg loading dose at 1st administration), iv over 1 h on day 1 of each 14 day cycle Docetaxel 50 mg/m², iv over 2 h on day 1 of each 14 day cycle Oxaliplatin 85 mg/m² in 500 ml G5%, iv over 2h on day 1 of each 14 day cycle Leucovorin 200 mg/m² in 250 ml NaCl 0,9%, iv over 1 h on day 1 of each cycle 5-FU 2600 mg/m², iv over 24 h on day 1 of each 14 day cycle |
| Post-operative treatment trastuzumab mono therapy | DRUG | Trastuzumab mono therapy for 9 cycles: Trastuzumab 6 mg/kg BW, iv over 1 h on day 1 of each 21 day cycle |
Inclusion Criteria: \- Histologically confirmed adenocarcinoma of the gastroesophageal junction (AEG I-III) or the stomach (uT2, uT3, uT4, any N category, M0), or any T N+ M0 patient, with the following specifications: Endosonography and an esophageal-gastro-duodenoscopy; Categorization of gastroes...
Post-operative treatment trastuzumab mono therapy is used for adenocarcinoma of the gastroesophageal junction. It is an investigational oncology treatment being studied as a perioperative therapy in patients with this condition, as well as adenocarcinoma of the stomach.
Post-operative treatment trastuzumab mono therapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research on this treatment for adenocarcinoma of the gastroesophageal junction.
Post-operative treatment trastuzumab mono therapy is in Phase 2 clinical development. It is an investigational treatment and has not been approved by regulatory authorities. One Phase 2 trial has been completed.
Post-operative treatment trastuzumab mono therapy has one completed clinical trial, NCT01472029. This was an explorative Phase II study of perioperative treatment in patients with adenocarcinoma of the gastroesophageal junction or stomach, conducted in Germany with 53 participants.
Post-operative treatment trastuzumab mono therapy is a trastuzumab monotherapy regimen. It refers to the use of trastuzumab as a single agent in the post-operative setting for adenocarcinoma of the gastroesophageal junction, rather than a distinct drug.