Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
pertuzumab · 2 trials · 21 indications
safety of a dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (riobciclib) plus endocrine therapy as compared to a dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus chemotherapy (followed by endocrine therapy plus ribociclib in combination with trastuzumab and pertuzumab as maintenance therapy) by the proportion of patients experiencing any adverse event (as defined by the modified adverse event score)
Defined as the highest dose level that does not lead to unacceptable toxicity in two or more patients in a dosing level.
Defined as no invasive tumor in the breast or lymph nodes at the time of surgery. Response evaluable participants are defined as participants who are randomized and have receive at least one cycle of protocol therapy. The pCR rate is defined as percentage of randomized patients with a pCR in each of the treatment arms.The estimated pCR rate (and 95% confidence interval \[CIs\]) will be calculated for each experimental arm and compared to the corresponding control arm using the Cochran-Mantel-Haenszel x\^2 test, with a two-sided significance level of 5%. Absolute differences in pCR rate between study arms will be calculated, along with 95% exact confidence intervals. This will be stratified according to hormone receptor (HR) status Multivariate logistic regression will be used to control for important baseline characteristics and odds ratios with corresponding CIs will be calculated.
| Arm | Type | Description |
|---|---|---|
| Chemotherapy with docetaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus docetaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with paclitaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus paclitaxel.Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with vinorelbine | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus vinorelbine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with capecitabine | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus capecitabine. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| endocrine therapy with exemestane | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus exemestane. |
| endocrine therapy with fulvestrant | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus fulvestrant. |
| endocrine therapy with anastrozole | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus anastrozole. |
| endocrine therapy with letrozole | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus letrozole. |
| Chemotherapy with nab-Paclitaxel | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab) and Perjeta® (pertuzumab) plus nab-Paclitaxel. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| Chemotherapy with eribulin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus eribulin. Up to three weeks after completion of chemotherapy, patients will be treated with maintenance endocrine therapy plus dual HER2-targeted therapy and Kisqali® (Ribociclib). |
| endocrine therapy with leuprorelin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus leuprorelin. |
| endocrine therapy with goserelin | EXPERIMENTAL | dual HER2-targeted therapy with Herceptin® (trastuzumab), Perjeta® (pertuzumab) and Kisqali® (Ribociclib) plus goserelin. |
| Phase Ib (ribociclib, tucatinib, trastuzumab) | EXPERIMENTAL | Patients receive ribociclib PO QD on days 1-21, tucatinib PO BID on days 1-28, and trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 4 cycles in the absence of disease progression or unacceptable toxicity. |
| Phase II, Arm C (ribociclib, tucatinib, trastuzumab) | EXPERIMENTAL | Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, and trastuzumab IV over 30-90 minutes every 7 days. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Phase II,Arm A(ribociclib,tucatinib, trastuzumab, fulvestrant) | EXPERIMENTAL | Patients receive ribociclib PO QD on days 1-21, tucatinib BID on days 1-28, trastuzumab IV over 30-90 minutes every 7 days and fulvestrant subcutaneously (SC) on days 1 and 15 of cycle 1 and day 1 of every subsequent cycle. Cycles repeat every 28 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Phase II,Arm B(docetaxel,carboplatin,trastuzumab,pertuzumab) | ACTIVE_COMPARATOR | Patients receive docetaxel IV over 1 hour on day 1, carboplatin IV on day 1, trastuzumab IV over 30-90 minutes on day 1, and pertuzumab IV over 1 hour on day 1. Cycles repeat every 21 days for up to 6 cycles in the absence of disease progression or unacceptable toxicity. |
| Name | Type | Description |
|---|---|---|
| pertuzumab | DRUG | HER2 targeted Therapy |
| Trastuzumab | DRUG | HER2 targeted Therapy |
| Capecitabine | DRUG | Chemotherapy |
| Paclitaxel | DRUG | Chemotherapy |
| Vinorelbine | DRUG | Chemotherapy |
| Docetaxel | DRUG | Chemotherapy |
| Exemestane | DRUG | endocrine therapy |
| Letrozole | DRUG | endocrine therapy |
| Anastrozole | DRUG | endocrine therapy |
| Fulvestrant | DRUG | endocrine therapy |
| Ribociclib | DRUG | CDK 4/6 inhibitor |
| nab-Paclitaxel | DRUG | chemotherapy |
| eribulin | DRUG | chemotherapy |
| leuprorelin | DRUG | endocrine therapy |
| goserelin | DRUG | endocrine therapy |
| Carboplatin | DRUG | Given IV |
| Quality-of-Life Assessment | OTHER | Ancillary Studies |
| Tucatinib | DRUG | Given PO |
Inclusion criteria: * Signed, written informed consent in study participation * The primary tumor and/or biopsies from metastatic sites or locoregional recurrences have been confirmed as HER2-positive (FISH-positive or IHC 3+) and hormone receptor positive breast cancer by histopathology according ...
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Pertuzumab is a monoclonal antibody being studied for the treatment of breast cancer, specifically Anatomic Stage II Breast Cancer AJCC v8 and Metastatic Breast Cancer. It is currently in clinical development and is not yet approved for these indications.
Pertuzumab is a monoclonal antibody that targets HER2, a protein that can promote the growth of cancer cells. It is being evaluated in HER2-positive breast cancer, as part of combination therapies for the treatment of the disease.
Pertuzumab is being developed by Novartis AG, a multinational pharmaceutical company. Novartis is listed on the stock exchange under the ticker symbol NVS.
Pertuzumab is currently in Phase 1 clinical trials. It is an investigational drug, meaning it has not yet received regulatory approval and is still being studied for safety and efficacy in patients with breast cancer.
Pertuzumab is being studied in two clinical trials. One is NCT02344472, a Phase 3 trial in Germany for metastatic breast cancer. The other is NCT05319873, a Phase 1 trial in the United States for HER2-positive breast cancer, testing it with ribociclib and trastuzumab.
Pertuzumab is the generic name for the drug also known as Perjeta. It is a HER2-targeted monoclonal antibody used in the treatment of HER2-positive breast cancer.