Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pertuzumab · 1 trial · 3 indications
Evaluate the ability of tucatinib in combination with trastuzumab/pertuzumab or TDM-1 to prolong intracranial progression free survival (PFS) in patients compared to historical controls. PFS is defined as the time from the day of study treatment initiation until evidence of intracranial disease progression per RANO-BM or death from any cause.
| Arm | Type | Description |
|---|---|---|
| Experimental Group | EXPERIMENTAL | Trastuzumab/pertuzumab + tucatinib or T-DM1 + tucatinib 300mg of tucatinib taken orally twice a day. Taken on Days 1-21 of a 21 Day cycle (3 Weeks). Trastuzumab/Biosimilar administered per current package insert based on site standard of care guidelines Pertuzumab or Biosimilar administered per current package insert based on site standard of care guidelines Trastuzumab Emtansine (T-DM1) administered per current package insert based on site standard of care guidelines |
| Name | Type | Description |
|---|---|---|
| Trastuzumab | DRUG | Administer per current package insert based on site standard of care guidelines |
| Trastuzumab Emtansine (T-DM1) | DRUG | Administer per current package insert based on site standard of care guidelines |
| Pertuzumab | DRUG | Administer per current package insert based on site standard of care guidelines |
| Tucatinib | DRUG | 300 mg orally twice daily (21 Day Cycle) |
Inclusion Criteria: Subject must meet all of the following applicable inclusion criteria to participate in this study: * Written informed consent and HIPAA authorization for release of personal health information prior to registration. NOTE: HIPAA authorization may be included in the informed cons...
Pertuzumab is an investigational antibody being studied for the treatment of brain metastases in patients with advanced human epidermal growth factor receptor 2 positive breast cancer. It is being evaluated in a Phase 2 clinical trial for this indication, specifically in combination with trastuzumab and tucatinib.
Pertuzumab is a monoclonal antibody, indicated by its -mab suffix, that targets the human epidermal growth factor receptor 2, commonly known as HER2. It is being studied in patients with HER2 positive advanced breast cancer who have brain metastases.
Pertuzumab is being developed by Pfizer, Inc., which is publicly traded under the ticker symbol PFE on the New York Stock Exchange. The company is conducting clinical research to evaluate the drug's safety and efficacy in patients with brain metastases.
Pertuzumab is currently in Phase 2 clinical development. It is an investigational drug and has not been approved by regulatory authorities. The ongoing Phase 2 trial is actively recruiting or has completed enrollment, with a total of 48 participants planned.
Pertuzumab is being studied in a single Phase 2 clinical trial registered as NCT05323955. This trial is evaluating the prevention of secondary brain metastases after isolated intracranial progression on trastuzumab/pertuzumab or T-DM1, with the addition of tucatinib in patients with advanced HER2 positive breast cancer.
No, Pertuzumab is not the same as trastuzumab. While both are monoclonal antibodies targeting HER2, they are distinct drugs. In the clinical trial, Pertuzumab is being studied in combination with trastuzumab and tucatinib for the treatment of brain metastases in HER2 positive breast cancer patients.