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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 an investigational monoclonal antibody given after surgery to patients with adenocarcinoma of the gastroesophageal junction. It was studied as a single-agent treatment in a Phase 2 trial of perioperative therapy. It is not described as approved and remains a clinical-stage asset.
It is used in the post-operative setting for adenocarcinoma of the gastroesophageal junction, and the same trial also enrolled patients with adenocarcinoma of the stomach. The Phase 2 study evaluated it as perioperative treatment in biomarker-selected patients. It is investigational and not an established standard of care.
Roche Holding AG is the developer of post-operative treatment trastuzumab mono therapy. The company trades under the ticker RHHBY. The asset was studied in a Roche-sponsored Phase 2 trial conducted in Germany.
Post-operative treatment trastuzumab mono therapy is in Phase 2 development. The single registered trial, NCT01472029, is a completed Phase 2 study. There are no active trials listed for this asset, and it is not described as FDA approved.
Post-operative treatment trastuzumab mono therapy was studied in NCT01472029, an explorative Phase 2 trial of perioperative treatment in patients with adenocarcinoma of the gastroesophageal junction or stomach. The trial enrolled 53 patients in Germany, was uncontrolled, was not randomized or double blinded, and has completed.
Yes. The Phase 2 trial NCT01472029 for post-operative treatment trastuzumab mono therapy was biomarker selected, meaning enrollment was restricted to patients whose tumors met a prespecified biomarker criterion. The study enrolled 53 patients aged 18 years and older of any sex, and it has completed.