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PTC+Pertuzumab · 1 trial · 2 indications
To compare the efficacy of six cycles neoadjuvant PTC plus pertuzumab preceded by either three cycles of FEC-T plus pertuzumab or three cycles of PTC plus pertuzumab in HER2 positive breast cancer
| Arm | Type | Description |
|---|---|---|
| FEC-T +Pertuzumab | ACTIVE_COMPARATOR | Fluorouracil; 500 mg/m2; day 1 Epirubicine; 90 mg/m2; day 1 Cyclophosphamide; 500 mg/m2; day 1 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg) Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle is repeated every 21 days |
| PTC+Pertuzumab | ACTIVE_COMPARATOR | Paclitaxel; 80 mg/m2; day 1,8 Trastuzumab; 6 mg/kg (loading dose 8 mg/kg); day 1 Carboplatin; AUC=6; day 1 Pertuzumab; 420 mg (loading dose 840 mg); day 1 Cycle repeated every 21 days |
| Name | Type | Description |
|---|---|---|
| PTC+Pertuzumab | DRUG | Cycle repeated every 21 days |
| FEC-T+Pertuzumab | DRUG | Cycle is repeated every 21 days |
Inclusion Criteria: * Histologically confirmed infiltrating breast cancer * Stage II or stage III disease. Nodal status must be examined by ultrasound, fine needle aspiration, sentinel node biopsy, or FDG-PET scan. * Overexpression and/or amplification of HER2 in an invasive component of the core b...
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PTC+Pertuzumab is a combination therapy being studied for the treatment of HER2-positive breast cancer. It is administered as neoadjuvant chemotherapy, meaning it is given before surgery to shrink tumors. The therapy is currently in Phase 3 clinical development and is intended for patients with this specific type of breast cancer.
PTC+Pertuzumab targets HER2, a protein that promotes the growth of cancer cells. Pertuzumab is a monoclonal antibody that binds to the HER2 receptor, while PTC refers to a small molecule component of the combination. This targeted approach is designed to treat HER2-positive breast cancer by interfering with cancer cell signaling.
PTC+Pertuzumab is being developed by Roche Holding AG, a multinational healthcare company. Roche's stock is traded under the ticker symbol RHHBY on the OTC market. The company is conducting clinical trials to evaluate the safety and efficacy of this combination therapy for breast cancer.
PTC+Pertuzumab is currently in Phase 3 clinical development. It is an investigational therapy, meaning it has not yet been approved by regulatory authorities. The ongoing Phase 3 trial is evaluating the combination as a neoadjuvant treatment for HER2-positive breast cancer, with active but not recruiting status.
PTC+Pertuzumab is being studied in a single Phase 3 clinical trial with the identifier NCT01996267. This trial, titled 'Neoadjuvant Chemotherapy in HER2 Positive Breast Cancer, TRAIN-2', is being conducted in the Netherlands and has enrolled 437 participants. The study is active but not recruiting, and it is randomized and active-controlled.
No, PTC+Pertuzumab is a combination therapy that includes Pertuzumab as one of its components. While Pertuzumab is a monoclonal antibody targeting HER2, the PTC component adds a small molecule to the regimen. This combination is being investigated specifically for its potential in neoadjuvant treatment of HER2-positive breast cancer.