Approval Probability
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Fixed-Dose Combination of Pertuzumab and Trastuzumab · 1 trial · 3 indications
The PPQ was used to evaluate the participant preference for PH FDC SC compared to P+H IV. Participants completed the PPQ, where Question (Q) 1 was: "All things considered, which setting for your treatment did you prefer?" Participants were required to select one of the following options: home, hospital or no preference. The reported results show the percentage of participants who preferred receiving PH FDC SC at home setting over the hospital setting. Percentages were rounded off.
| Arm | Type | Description |
|---|---|---|
| Arm A: Pertuzumab IV and Trastuzumab IV Plus Investigator's Choice of Chemotherapy | OTHER | During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with pertuzumab and trastuzumab intravenously (PH IV) plus investigator's choice of chemotherapy (Option 1, 2, or 3). With chemotherapy Option 1, PH IV will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH IV will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks). |
| Arm B: PH FDC SC Plus Investigator's Choice of Chemotherapy | OTHER | During the neoadjuvant phase, the enrolled participants randomized to this arm will receive treatment with the fixed dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC) plus investigator's choice of chemotherapy (Option 1, 2, or 3). With chemotherapy Option 1, PH FDC SC will be administered at each cycle from Cycles 1 to 6 (1 cycle is 3 weeks); with chemotherapy Options 2 and 3, PH FDC SC will be administered once per cycle from Cycles 5 to 8 (1 cycle is 3 weeks). |
| Arm C: Adjuvant PH FDC SC in Hospital, Then at Home | EXPERIMENTAL | During the adjuvant phase, participants who have achieved pCR after surgery will be treated with 2 cycles of PH FDC SC in the hospital (run-in period). After completion of the last cycle of radiotherapy and the last cycle of PH FDC SC (run-in period), participants will then be randomized with a ratio of 1:1 into one of two treatment arms (Arm C or D) in a cross-over treatment period to receive the next 6 cycles of PH FDC SC treatment. Participants in Arm C will receive 3 cycles of PH FDC SC in the hospital and then 3 cycles of PH FDC SC in the home setting. After the cross-over treatment period, participants will receive the remaining PH FDC SC treatment cycles required to complete the planned 18 cycles of HER2-directed therapy, unless of disease recurrence, unacceptable toxicity, or withdrawal. Study treatment during this treatment continuation period will be administered either in the hospital or in the home setting as selected by the participant at the end of the crossover period. |
| Arm D: Adjuvant PH FDC SC at Home, Then in Hospital | EXPERIMENTAL | During the adjuvant phase, participants who have achieved pCR after surgery will be treated with 2 cycles of PH FDC SC in the hospital (run-in period). After completion of the last cycle of radiotherapy and the last cycle of PH FDC SC (run-in period), participants will then be randomized with a ratio of 1:1 into one of two treatment arms (Arm C or D) in a cross-over treatment period to receive the next 6 cycles of PH FDC SC treatment. Participants in Arm D will receive 3 cycles of PH FDC SC in the home setting and then 3 cycles of PH FDC SC in the hospital. After the cross-over treatment period, participants will receive the remaining PH FDC SC treatment cycles required to complete the planned 18 cycles of HER2-directed therapy, unless of disease recurrence, unacceptable toxicity, or withdrawal. Study treatment during this treatment continuation period will be administered either in the hospital or in the home setting as selected by the participant at the end of the crossover period. |
| Arm E: Adjuvant Trastuzumab Emtansine | OTHER | Participants with pathological evidence of residual invasive carcinoma in the breast or axillary lymph nodes following completion of preoperative therapy and surgery will enter Arm E to receive trastuzumab emtansine for 14 cycles. Trastuzumab emtansine will be administered IV in the hospital as per prescribing information. |
| Name | Type | Description |
|---|---|---|
| Fixed Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Use (PH FDC SC) | DRUG | PH FDC SC is administered subcutaneously (SC) as a fixed non-weight-based dose. A loading dose of 1200 milligram (mg) pertuzumab, 600 mg trastuzumab, and 30,000 units of recombinant human PH20 hyaluronidase (rHuPH20) is given in the first cycle (1 cycle is 21 days). In subsequent cycles, maintenance doses of 600 mg pertuzumab, 600 mg trastuzumab, and 20,000 units rHuPH20 are administered once every 3 weeks (Q3W). |
| Pertuzumab IV | DRUG | Pertuzumab is given as a fixed dose of 840 mg intravenous (IV) loading dose and then 420 mg IV for subsequent maintenance doses once every 3 weeks. |
| Trastuzumab IV | DRUG | Trastuzumab is given as an 8 milligram per kilogram (mg/kg) intravenous (IV) loading dose and then 6 mg/kg IV for subsequent maintenance doses once every 3 weeks. |
| Trastuzumab Emtansine | DRUG | Trastuzumab emtansine will be given at a dose of 3.6 mg/kg by intravenous (IV) infusion, once every 3 weeks. |
| Investigator's Choice of Chemotherapy | DRUG | Option 1: Docetaxel and carboplatin once every 3 weeks for 6 cycles; Option 2: Doxorubicin plus cyclophosphamide once every 3 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles); Option 3: Dose-dense doxorubicin plus cyclophosphamide (ddAC) once every 2 weeks for 4 cycles, followed by a taxane (docetaxel once every 3 weeks for 4 cycles or paclitaxel once every week for 12 cycles). |
| Surgery | PROCEDURE | After completing their neoadjuvant therapy, participants will undergo surgical resection for early or locally advanced HER2+ breast cancer (if eligible for surgery). Participants may undergo breast-conserving surgery or mastectomy according to routine clinical practice. The surgery cannot be performed ≤2 weeks from the last systemic neoadjuvant therapy and must be performed ≤6 weeks after the last systemic neoadjuvant therapy. |
| Radiotherapy | RADIATION | After surgery, radiotherapy is to be given as clinically indicated and as per local practice or institutional standards. The selected radiotherapy regimen should be initiated within 4 weeks after surgery. |
Inclusion Criteria: * Eastern Cooperative Oncology Group (ECOG) performance status 0-1 * Intact skin at planned site of subcutaneous (SC) injections * Left ventricular ejection fraction (LVEF) greater than or equal to (≥)55% by echocardiogram (ECHO) or multiple-gated acquisition scan (MUGA) * Negat...
The fixed-dose combination of pertuzumab and trastuzumab is an investigational subcutaneous monoclonal antibody combination developed by Roche Holding AG (ticker RHHBY). It combines two HER2-targeted antibodies in a single fixed-dose formulation for subcutaneous administration, studied in patients with HER2-positive early breast cancer, including locally advanced and inflammatory disease.
It is being studied for the treatment of HER2-positive early breast cancer, including locally advanced and inflammatory breast cancer. The Phase 3 trial enrolled participants with these HER2-positive conditions, and the study evaluated patient preference for home administration of the subcutaneous fixed-dose combination.
Roche Holding AG, which trades under the ticker RHHBY, is the developer of the fixed-dose combination of pertuzumab and trastuzumab. Roche is the company behind the subcutaneous fixed-dose combination program studied in HER2-positive breast cancer.
The fixed-dose combination of pertuzumab and trastuzumab is in Phase 3 development. Its Phase 3 trial, NCT05415215, has been completed. The drug is investigational and is not described as approved; it remains in clinical development for HER2-positive early breast cancer.
The fixed-dose combination of pertuzumab and trastuzumab was studied in Phase 3 trial NCT05415215, titled a study to evaluate patient preference for home administration of the fixed-dose combination for subcutaneous administration in participants with early or locally advanced or inflammatory HER2-positive breast cancer. The trial was completed and enrolled 346 participants across multiple countries.
Yes. The fixed-dose combination of pertuzumab and trastuzumab is also known as PH FDC SC, the fixed-dose combination of pertuzumab and trastuzumab for subcutaneous use (PH FDC SC), and the fixed-dose combination of pertuzumab and trastuzumab for use. These names refer to the same Roche subcutaneous antibody combination.