Approval Probability
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Adjusted LOA
ML Risk
Pertuzumab · 1 trial · 4 indications
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 ...
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Pertuzumab is an investigational antibody being studied for the treatment of breast cancer, specifically in patients with HER2-positive, stage II or stage III breast cancer. It is currently in Phase 2 clinical development and has not been approved by regulatory authorities.
Pertuzumab is a monoclonal antibody (mab) that targets the HER2 receptor, which is overexpressed in HER2-positive breast cancers. By binding to HER2, it is designed to interfere with cancer cell growth and survival signals, though its full mechanism is still under investigation in clinical trials.
Pertuzumab is being developed by MacroGenics, Inc., a biopharmaceutical company traded on the NASDAQ under the ticker symbol MGNX. The company is conducting clinical trials to evaluate the drug's safety and efficacy in breast cancer patients.
Pertuzumab is currently in Phase 2 clinical development. It is an investigational drug, meaning it has not yet been approved by the FDA or other regulatory agencies, and its safety and efficacy are still being evaluated in clinical trials.
Pertuzumab is being studied in the MARGetuximab Or Trastuzumab (MARGOT) trial, registered as NCT04425018. This Phase 2, randomized, controlled trial is enrolling 174 patients with HER2-positive stage II or stage III breast cancer in the United States, and it is currently active but not recruiting.
No, Pertuzumab is not the same as Margetuximab. The MARGOT trial (NCT04425018) compares Pertuzumab against Margetuximab or Trastuzumab as treatment options for HER2-positive breast cancer, indicating they are distinct investigational antibodies being evaluated in the same study.