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Also known as Phesgo 1, 30,000 UNT Per
Phesgo · 1 trial · 1 indication
| Arm | Type | Description |
|---|---|---|
| Induction Therapy: Phesgo plus Taxane-Based Chemotherapy | OTHER | - |
| Arm A, Maintenance Therapy: Phesgo | ACTIVE_COMPARATOR | - |
| Arm B, Maintenance Therapy: Giredestrant plus Phesgo | EXPERIMENTAL | - |
| Name | Type | Description |
|---|---|---|
| Phesgo | DRUG | Phesgo will be administered subcutaneously (SC) at a fixed non-weight-based dose. In the induction therapy phase, a loading dose (1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase \[rHuPH20\]) will be administered in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses (600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20) will be administered once every 3 weeks (Q3W). |
| Giredestrant | DRUG | A 30 milligram (mg) capsule of giredestrant will be taken orally once a day on Days 1 to 21 of each 21-day cycle. |
| Docetaxel | DRUG | During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Docetaxel will be administered at 75 milligrams per metre squared of body surface area (mg/m2) intravenously over 60 (±10) minutes on Day 1 of each cycle for 4 to 8 cycles (a cycle is 21 days); this dose may be escalated to 100 mg/m2 if the initial dose was well tolerated. |
| Paclitaxel | DRUG | During the induction therapy phase, the investigator's choice of taxane-based chemotherapy (i.e., docetaxel or paclitaxel) will be administered after Phesgo. Paclitaxel will be administered at 80 milligrams per metre squared of body surface area (mg/m2) intravenously over a minimum of 1 hour on Days 1, 8, and 15 of each cycle for 4 to 8 cycles (a cycle is 21 days); this weekly regimen is considered as one complete cycle whenever 3 weekly doses are given. |
| LHRH Agonist | DRUG | A luteinizing hormone-releasing hormone (LHRH) agonist will be administered every 28 days to pre- and peri-menopausal women and all male participants while receiving giredestrant in Arm B. An LHRH agonist may be administered to male participants and pre- and peri-menopausal female participants receiving tamoxifen in Arm A, and should be administered to those receiving an aromatase inhibitor in Arm A. The investigator will determine and supply the appropriate LHRH agonist locally approved for use in breast cancer. The LHRH agonist will be administered according to local prescribing information. |
| Optional Endocrine Therapy of Investigator's Choice | DRUG | For participants in Arm A, optional endocrine therapy of investigator's choice is allowed based on the standard of care, and it can include an aromatase inhibitor or tamoxifen with or without an LHRH agonist, or gonadal ablation. The decision to include or exclude this option must be made prior to randomization. |
Inclusion Criteria: * Histologically or cytologically confirmed and documented human epidermal growth factor receptor 2 (HER2)-positive/estrogen receptor (ER)-positive adenocarcinoma of the breast with metastatic or locally-advanced disease not amenable to curative resection * At least one measurab...
Phesgo is an investigational combination therapy being studied for the treatment of locally advanced or metastatic breast cancer. It is being evaluated in a Phase 3 clinical trial in combination with giredestrant versus Phesgo alone in participants with this condition.
Phesgo contains pertuzumab, trastuzumab, and hyaluronidase-zzxf. Pertuzumab and trastuzumab are monoclonal antibodies that target the HER2 receptor, while hyaluronidase-zzxf is an enzyme that helps with subcutaneous delivery of the medication.
Phesgo is being developed by Roche Holding AG, which trades under the ticker RHHBY. The company is conducting a Phase 3 clinical trial to evaluate the efficacy and safety of Phesgo in combination with giredestrant for locally advanced or metastatic breast cancer.
Phesgo is currently in Phase 3 clinical development. It is being studied in an active, not recruiting trial with an enrollment of 922 participants, evaluating its use in locally advanced or metastatic breast cancer.
Phesgo is being studied in the Phase 3 clinical trial NCT05296798, titled 'A Study to Evaluate the Efficacy and Safety of Giredestrant in Combination With Phesgo (Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf) Versus Phesgo in Participants With Locally Advanced or Metastatic Breast Cancer (heredERA Breast Cancer).'
Yes, Phesgo is also known as Phesgo 1,200 MG / 600 MG / 30,000 UNT Per 15 ML Injection and Phesgo 1, 30,000 UNT Per. These names refer to the same drug product being developed by Roche.