Approval Probability
TA Base Rate
Adjusted LOA
ML Risk
Pertuzumab · 2 trials · 7 indications
PFS is defined as the time from initiation of T-DXd + pertuzumab until PD or death, whichever occurs first.
Proportion of participants who have no evidence by Hematoxylin \& Eosin (H\&E) staining of residual invasive disease in the complete resected breast specimen and all sampled regional lymph nodes (ypT0/Tis ypN0) by central evaluation following completion of neoadjuvant therapy.
| Arm | Type | Description |
|---|---|---|
| T-DXd | EXPERIMENTAL | Adult participants with previously untreated advanced or metastatic HER2+/HR+ breast cancer who will receive T-DXd intravenously every 3 weeks (IV Q3W) in 3 treatment phases: Upfront treatment phase: T-DXd + pertuzumab IV Q3W Maintenance treatment phase: Trastuzumab + palbociclib + endocrine therapy + pertuzumab IV Q3W T-DXD retreatment phase: T-DXd monotherapy IV Q3W |
| Arm A | EXPERIMENTAL | Trastuzumab deruxtecan |
| Arm B | EXPERIMENTAL | T-DXd, followed by THP |
| Arm C | ACTIVE_COMPARATOR | doxorubicin and cyclophosphamide, followed by THP |
| Name | Type | Description |
|---|---|---|
| Trastuzumab deruxtecan | DRUG | Upfront treatment: One IV infusion Q3W 5.4 mg/kg (starting dose) on Day 1 of each 21-day cycle T-DXd Retreatment: One IV infusion Q3W 5.4 mg/kg (starting dose) on Day 1 of each 21-day cycle \*Dose reductions implemented during Upfront treatment phase will be maintained. |
| Trastuzumab | DRUG | Maintenance treatment: One IV infusion Q3W 6 mg/kg on Day 1 of each 21-day cycle |
| Pertuzumab | DRUG | Upfront treatment: One IV infusion Q3W loading dose of 840 mg, then 420 mg Q3W thereafter on Day 1 of each 21-day cycle Maintenance treatment: One IV infusion Q3W 420 mg on Day 1 of each 21-day cycle |
| Endocrine Therapy | DRUG | Aromatase inhibitors or fulvestrant administered as approved product label |
| Palbociclib | DRUG | Maintenance treatment: Daily (3 out of 4 weeks, Q4W) oral 125 mg |
| Paclitaxel | DRUG | administered by intravenous infusion |
| Doxorubicin | DRUG | administered by intravenous infusion |
| cyclophosphamide | DRUG | administered by intravenous infusion |
Key Inclusion Criteria for Upfront Treatment Phase 1. Sign and date the Main Trial informed consent form (ICF), prior to the start of any trial-specific procedures. 2. Participant must be ≥18 years of age at the time the ICF is signed. 3. Have pathologically documented breast cancer that: * Is ...
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Pertuzumab is an investigational antibody being studied for the treatment of breast cancer, including HER2-positive early breast cancer and HER2-positive, HR-positive advanced or metastatic breast cancer. It is currently in Phase 3 clinical development.
Pertuzumab is a monoclonal antibody (-mab) that targets HER2, a protein that promotes cancer cell growth. By binding to HER2, it is designed to block signaling pathways that drive tumor proliferation in HER2-positive breast cancers.
Pertuzumab is being developed by AstraZeneca PLC, a biopharmaceutical company listed on the stock exchange under the ticker symbol AZN.
Pertuzumab is currently in Phase 3 clinical trials. It is an investigational drug and has not yet been approved by regulatory authorities for any indication.
Pertuzumab is being evaluated in two Phase 3 trials. NCT05113251 is an active, not recruiting study of T-DXd alone or in sequence with THP versus standard treatment in HER2-positive early breast cancer. NCT07683754 is a not yet recruiting study of T-DXd-based therapy followed by endocrine therapy plus dual HER2 blockade in first-line HER2+/HR+ metastatic breast cancer.
No, Pertuzumab is a distinct monoclonal antibody from trastuzumab. While both target HER2, they bind to different epitopes on the HER2 receptor. In clinical trials, Pertuzumab is often studied in combination with trastuzumab as part of dual HER2 blockade therapy.