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Neo-adjuvant chemotherapy · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Trastuzumab | EXPERIMENTAL | In adjuvant setting trastuzumab will be administered in the following treatment regimens: (a) trastuzumab following surgery, chemotherapy (neo-adjuvant or adjuvant) and radiotherapy (if applicable); (b) trastuzumab following adjuvant chemotherapy with doxorubicin and cyclophosphamide, in combination with paclitaxel or docetaxel; (c) trastuzumab in combination with adjuvant chemotherapy consisting of docetaxel and carboplatin. In neo-adjuvant setting, trastuzumab will be administered in combination with neo-adjuvant chemotherapy followed by adjuvant trastuzumab, for locally advanced (including inflammatory) breast cancer or tumors greater than (\>) 2 centimeters (cm) in diameter. |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | Trastuzumab will be administered subcutaneously at a fixed dose of 600 mg (irrespective of body weight) every 3 weeks for 1 year (adjuvant or neo-adjuvant plus adjuvant therapy). |
| Doxorubicin | DRUG | Doxorubicin will be administered in combination with trastuzumab and cyclophosphamide in the adjuvant setting as per local Product Information and the investigator's discretion. |
| Cyclophosphamide | DRUG | Cyclophosphamide will be administered in combination with trastuzumab and doxorubicin in the adjuvant setting as per local Product Information and the investigator's discretion. |
| Paclitaxel | DRUG | Paclitaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion. |
| Docetaxel | DRUG | Docetaxel will be administered in combination with trastuzumab in the adjuvant setting as per local Product Information and the investigator's discretion. |
| Carboplatin | DRUG | Carboplatin will be administered in combination with trastuzumab and docetaxel in the adjuvant setting as per local Product Information and the investigator's discretion. |
| Neo-adjuvant chemotherapy | DRUG | Neo-adjuvant chemotherapy will be administered according to local guidelines in combination with trastuzumab in the neo-adjuvant setting. The study protocol does not mention any specific neo-adjuvant chemotherapy drug names. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Hormonal therapy will be allowed as per institutional guidelines * Prior use of anti-HER2 therapy will be allowed, except for early breast cancer participants in the neo-adjuvant setting * Left ventricular ejec...
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Neo-adjuvant chemotherapy is used for breast cancer, specifically in the treatment of HER2-positive early breast cancer. It is administered before the main treatment to shrink tumors. In the context of the clinical trial data, it is part of a study evaluating participant satisfaction and safety with subcutaneously administered trastuzumab.
Neo-adjuvant chemotherapy is developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting clinical research involving this treatment approach for breast cancer.
Neo-adjuvant chemotherapy is in Phase 3 clinical development. The associated trial, NCT01964391, is a Phase 3 study that has been completed. It is an investigational treatment approach and is not yet approved for general use.
Neo-adjuvant chemotherapy is associated with one completed Phase 3 clinical trial, NCT01964391. This study enrolled 174 participants with HER2-positive early breast cancer and evaluated participant satisfaction and safety with subcutaneously administered trastuzumab. The trial was conducted in Algeria, Morocco, Saudi Arabia, Tunisia, and Turkey.
Neo-adjuvant chemotherapy is not the same as trastuzumab. Trastuzumab is a specific drug used in the treatment of HER2-positive breast cancer, while neo-adjuvant chemotherapy refers to the timing of treatment, given before the primary therapy. In the clinical trial, trastuzumab is administered as part of the neo-adjuvant regimen.