{"id":"pertuzumab-and-trastuzumab-fdc-sc","safety":{"commonSideEffects":[{"rate":"40-50","effect":"Diarrhea"},{"rate":"30-40","effect":"Nausea"},{"rate":"25-35","effect":"Fatigue"},{"rate":"20-30","effect":"Vomiting"},{"rate":"5-10","effect":"Decreased left ventricular ejection fraction (LVEF)"},{"rate":"5-15","effect":"Infusion-related reactions"},{"rate":"10-20","effect":"Rash"}]},"_chembl":null,"_dailymed":null,"mechanism":{"_ai_source":"claude-haiku-4.5","explanation":"Pertuzumab binds to HER2 domain II and blocks ligand-induced HER2 heterodimerization, while trastuzumab binds to domain IV and mediates antibody-dependent cellular cytotoxicity (ADCC) and inhibits HER2 signaling. Together, they provide complementary mechanisms of HER2 inhibition in HER2-positive cancers. The subcutaneous formulation improves patient convenience compared to intravenous administration.","oneSentence":"This fixed-dose combination of two monoclonal antibodies blocks HER2 signaling by targeting different epitopes on the HER2 receptor, preventing tumor cell growth and survival.","_ai_confidence":"high"},"_scrapedAt":"2026-03-28T00:49:42.016Z","_scrapedBy":"cloudflare-swarm","_wikipedia":null,"indications":{"approved":[{"name":"HER2-positive metastatic breast cancer"},{"name":"HER2-positive early breast cancer (neoadjuvant and adjuvant settings)"}]},"trialDetails":[{"nctId":"NCT04802759","phase":"PHASE1, PHASE2","title":"A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Participants With Breast Cancer","status":"RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2021-06-22","conditions":"Inoperable, Locally Advanced or Metastatic, ER-positive Breast Cancer","enrollment":316},{"nctId":"NCT04024462","phase":"PHASE3","title":"A Two-Arm Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Chinese Participants With HER2-Positive Early Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2020-02-05","conditions":"HER2-positive Early Breast Cancer","enrollment":200},{"nctId":"NCT05415215","phase":"PHASE3","title":"A Study to Evaluate Patient Preference for Home Administration of Fixed-Dose Combination of Pertuzumab and Trastuzumab for Subcutaneous Administration in Participants With Early or Locally Advanced/Inflammatory HER2-Positive Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2022-07-05","conditions":"Early Breast Cancer, Locally Advanced Breast Cancer, Inflammatory Breast Cancer","enrollment":346},{"nctId":"NCT05296798","phase":"PHASE3","title":"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)","status":"ACTIVE_NOT_RECRUITING","sponsor":"Hoffmann-La Roche","startDate":"2022-07-18","conditions":"Locally Advanced or Metastatic Breast Cancer","enrollment":922},{"nctId":"NCT07245797","phase":"PHASE2","title":"A Phase II, Multicenter, Open-label Study to Evaluate the Efficacy and Safety of Neoadjuvant Therapy With Inavolisib Plus Pertuzumab and Trastuzumab as Subcutaneous (PH-FDC SC) and 3-week Cycle Nab-paclitaxel for PIK3CA-mutated, HER2+, eBC","status":"NOT_YET_RECRUITING","sponsor":"Zhimin Shao","startDate":"2025-12-15","conditions":"Breast Cancer","enrollment":164},{"nctId":"NCT04733118","phase":"PHASE2","title":"Chemotherapy-Free pCR-Guided Strategy With Trastuzumab-pertuzumab and T-DM1 in HER2-positive Early Breast Cancer","status":"ACTIVE_NOT_RECRUITING","sponsor":"MedSIR","startDate":"2021-08-05","conditions":"Early Breast Cancer","enrollment":393},{"nctId":"NCT04569747","phase":"PHASE2","title":"A Single Arm Phase II Study of ADjuvant Endocrine Therapy, Pertuzumab, and Trastuzumab for Patients With Anatomic Stage I Hormone Receptor-positive, HER2-positive Breast Cancer","status":"RECRUITING","sponsor":"Dana-Farber Cancer Institute","startDate":"2021-01-11","conditions":"HER2-positive Breast Cancer, Invasive Carcinoma of the Breast, Breast Cancer","enrollment":375},{"nctId":"NCT06172127","phase":"PHASE2","title":"PHESGO Maintenance After T-DXd Short Induction for HER2+ Unresectable Locally Recurrent or Metastatic Breast Cancer","status":"RECRUITING","sponsor":"MedSIR","startDate":"2024-07-22","conditions":"HER2-positive Breast Cancer","enrollment":165},{"nctId":"NCT06835348","phase":"","title":"An Observational, Multicenter Study Evaluating the Safety of ReAl-lifePertuzumab and Trastuzumab Fixed Dose Combination: the RAPID Study","status":"COMPLETED","sponsor":"Fondazione Oncotech","startDate":"2023-10-03","conditions":"Breast Cancer","enrollment":80},{"nctId":"NCT05306041","phase":"PHASE2","title":"Neoadjuvant Endocrine Therapy +/- the PI3K Inhibitor Inavolisib in HER2+, HR+, PIK3CA Mutant Early Breast Cancer","status":"RECRUITING","sponsor":"GBG Forschungs GmbH","startDate":"2023-01-02","conditions":"HER2-positive Breast Cancer","enrollment":170},{"nctId":"NCT04632992","phase":"PHASE2","title":"A Study Evaluating Targeted Therapies in Participants Who Have Advanced Solid Tumors With Genomic Alterations or Protein Expression Patterns Predictive of Response","status":"COMPLETED","sponsor":"Genentech, Inc.","startDate":"2021-01-13","conditions":"Advanced Unresectable or Metastatic Solid Malignancy","enrollment":252},{"nctId":"NCT04675827","phase":"PHASE2","title":"De-escalation Adjuvant Chemo in HER2+/ER-/node-neg Early BC Patients Who Achieved PCR After Neoadjuvant Chemo & Dual HER2 Blockade","status":"TERMINATED","sponsor":"Jules Bordet Institute","startDate":"2022-01-17","conditions":"HER2-positive Breast Cancer, ER-Negative Breast Cancer, PR-Negative Breast Cancer","enrollment":139},{"nctId":"NCT05275010","phase":"PHASE1","title":"A Study in Healthy Male Subjects to Investigate the Comparability of Pharmacokinetics of the Fixed-Dose Combination of Pertuzumab and Trastuzumab Administered Subcutaneously Using a Handheld Syringe or Using the On-Body Delivery System","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2022-05-30","conditions":"Healthy Male Subjects","enrollment":151},{"nctId":"NCT03493854","phase":"PHASE3","title":"A Study to Evaluate the Pharmacokinetics, Efficacy, and Safety of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Combination With Chemotherapy in Participants With HER2-Positive Early Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2018-06-14","conditions":"Early Breast Cancer","enrollment":500},{"nctId":"NCT03674112","phase":"PHASE2","title":"A Study to Evaluate Patient Preference and Satisfaction of Subcutaneous Administration of the Fixed-Dose Combination of Pertuzumab and Trastuzumab in Participants With HER2-Positive Early Breast Cancer","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2018-12-19","conditions":"HER2-Positive Early Breast Cancer","enrollment":160},{"nctId":"NCT04395508","phase":"","title":"An Expanded Access Study to Provide at Home Subcutaneous Administration of Pertuzumab and Trastuzumab Fixed-Dose Combination (PH FDC SC) for Patients With HER2-Positive Breast Cancer During the COVID-19 Pandemic","status":"APPROVED_FOR_MARKETING","sponsor":"Genentech, Inc.","startDate":"","conditions":"HER2-positive Breast Cancer","enrollment":""},{"nctId":"NCT02738970","phase":"PHASE1","title":"A Dose-Finding Study of Pertuzumab (Perjeta) in Combination With Trastuzumab (Herceptin) in Healthy Male Participants and Women With Early Breast Cancer (EBC)","status":"COMPLETED","sponsor":"Hoffmann-La Roche","startDate":"2016-06-23","conditions":"Early Breast Cancer","enrollment":88}],"_emaApprovals":[],"_faersSignals":[],"_approvalHistory":[],"publicationCount":0,"rwe":[],"genericFilers":[],"relatedDrugs":[],"labelChanges":[],"biosimilarFilings":[],"pricing":[],"formularyStatus":[],"manufacturing":[],"companionDiagnostics":[],"competitors":[],"timeline":[],"patents":[],"ownershipHistory":[],"trials":[],"biosimilars":[],"latestUpdates":[],"references":[],"tags":[],"ecosystem":[],"genericManufacturerList":[],"offLabel":[],"developmentCodes":[],"aliases":["Pertuzumab, Trastuzumab, and Hyaluronidase-zzxf","PHESGO™","PH FDC SC","RG6264","RO7198574"],"phase":"phase_3","status":"active","brandName":"Pertuzumab and Trastuzumab FDC SC","genericName":"Pertuzumab and Trastuzumab FDC SC","companyName":"Hoffmann-La Roche","companyId":"roche","modality":"Small molecule","firstApprovalDate":"","aiSummary":"This fixed-dose combination of two monoclonal antibodies blocks HER2 signaling by targeting different epitopes on the HER2 receptor, preventing tumor cell growth and survival. Used for HER2-positive metastatic breast cancer, HER2-positive early breast cancer (neoadjuvant and adjuvant settings).","enrichmentLevel":3,"visitCount":0,"trialStats":{"total":1,"withResults":1},"verificationStatus":"verified","dataCompleteness":{"mechanism":true,"indications":true,"safety":true,"trials":true,"score":4}}