CLINICAL TRIALS PROFILE FOR PERTUZUMAB
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Biosimilar Clinical Trials for pertuzumab
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT03811418 ↗ | A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer | Withdrawn | Amgen | Phase 3 | 2019-01-01 | This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first. |
NCT03811418 ↗ | A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer | Withdrawn | Arbeitsgemeinschaft fur Internistische Onkologie | Phase 3 | 2019-01-01 | This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first. |
NCT03811418 ↗ | A Study to Compare Pertuzumab + Trastuzumab + Vinorelbine vs. Placebo + Trastuzumab + Docetaxel in Previously Untreated HER2-positive Metastatic Breast Cancer | Withdrawn | iOMEDICO AG | Phase 3 | 2019-01-01 | This is a randomized, open-label, two-arm, phase III trial in Germany to investigate whether vinorelbine-based triple combination presents a less toxic treatment option than docetaxel-based triple combination in patients with HER2-positive advanced breast cancer who have not previously received any systemic treatment in the metastatic setting. The primary objective of the study is to compare patient-reported quality of life in the two treatment arms. Patients will be followed-up for survival until death or end of study after at least 79 deaths occured in each arm, whatever comes first. |
NCT03988036 ↗ | A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) | Recruiting | Amgen | Phase 2 | 2020-08-18 | Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50. |
NCT03988036 ↗ | A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) | Recruiting | Merck Sharp & Dohme Corp. | Phase 2 | 2020-08-18 | Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50. |
NCT03988036 ↗ | A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) | Recruiting | NanoString Technologies, Inc. | Phase 2 | 2020-08-18 | Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50. |
NCT03988036 ↗ | A Study With Pembrolizumab in Combination With Dual Anti-HER2 Blockade With Trastuzumab and Pertuzumab in Early Breast Cancer Patients With Molecular HER2-enriched Intrinsic Subtype (Keyriched-1) | Recruiting | West German Study Group | Phase 2 | 2020-08-18 | Keyriched-1 is a multicenter, interventional, prospective, single arm, open label, neoadjuvant phase II trial evaluating the pathological complete response (pCR) rate induced by pembrolizumab in combination with the dual anti-HER2 blockade consisting of trastuzumab biosimilar ABP 980 and pertuzumab in early breast cancer patients with molecular HER2-enriched intrinsic subtype tested by PAM50. |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
All Clinical Trials for pertuzumab
Trial ID | Title | Status | Sponsor | Phase | Start Date | Summary |
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NCT00058539 ↗ | Safety and Efficacy Study of Pertuzumab to Treat Castration-Resistant Prostate Cancer | Completed | Genentech, Inc. | Phase 2 | 2003-04-01 | The purpose of this study is to evaluate safety and efficacy of Omnitarg (Pertuzumab) on cancerous lesions in men with castration-resistant (hormone-refractory) prostate cancer. |
NCT00058552 ↗ | A Study to Evaluate the Effect of HER2 Activation on rhuMAb 2C4 (Pertuzumab) in Subjects With Advanced Ovarian Cancer | Completed | Genentech, Inc. | Phase 2 | 2003-05-01 | The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced ovarian cancer that is refractory to, or has recurred following, prior chemotherapy. |
NCT00063154 ↗ | Safety and Effect of Pertuzumab in Patients With Advanced Non-Small Cell Lung Cancer, Which Has Progressed After Prior Chemotherapy | Completed | Genentech, Inc. | Phase 2 | 2003-07-01 | The purpose of this study is to determine if the study drug pertuzumab is effective in treating patients with advanced lung cancer that has recurred following prior chemotherapy. |
NCT00096941 ↗ | A Study to Evaluate Subjects Treated With rhuMab 2C4 (Pertuzumab) in a Previous Genentech Phase II Cancer Study | Completed | Genentech, Inc. | Phase 2 | 2005-05-01 | This is a multicenter, open label extension study. Subjects who have completed treatment in the parent study of pertuzumab, either alone or with a combination agent, and who received at least one dose of pertuzumab in the parent study are eligible for inclusion in this trial if they are continuing to receive clinical benefit. |
NCT00096993 ↗ | A Study to Evaluate rhuMab 2C4 and Gemcitabine in Subjects With Ovarian, Primary Peritoneal, or Fallopian Tube Cancer | Completed | Genentech, Inc. | Phase 2 | 2005-01-01 | This is a Phase II, randomized, placebo-controlled, double-blind, multicenter clinical trial of pertuzumab in combination with gemcitabine relative to placebo in combination with gemcitabine in subjects with advanced ovarian, primary peritoneal, or fallopian tube cancer that is resistant to platinum-based chemotherapy. |
NCT00545688 ↗ | A Study of Pertuzumab in Combination With Herceptin in Patients With HER2 Positive Breast Cancer. | Completed | Hoffmann-La Roche | Phase 2 | 2006-06-26 | This 4 arm study will evaluate the efficacy and safety of 4 neoadjuvant treatment regimens in female patients with locally advanced, inflammatory or early stage HER2 positive breast cancer. Before surgery, patients will be randomized to one of 4 treatment arms, to receive 4 cycles of a)Herceptin + docetaxel b)Herceptin + docetaxel + pertuzumab c)Herceptin + pertuzumab or 4)pertuzumab + docetaxel. Pertuzumab will be administered at a loading dose of 840mg iv, then 420mg iv 3-weekly, Herceptin at a loading dose of 8mg/kg iv then 6mg/kg 3-weekly, and docetaxel at a dose of 75mg/m2 escalating to 100mg/m2 3-weekly. During the entire pre- and post-surgery period all patients will receive adequate chemotherapy as per standard of care, as well as any surgery and/or radiotherapy as required. The anticipated time on study treatment is 3-12 months, and the target sample size is 100-500 individuals. |
NCT00551421 ↗ | Pertuzumab and Cetuximab in Treating Patients With Previously Treated Locally Advanced or Metastatic Colorectal Cancer | Completed | National Cancer Institute (NCI) | Phase 1/Phase 2 | 2007-10-01 | Monoclonal antibodies, such as pertuzumab and cetuximab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Giving pertuzumab together with cetuximab may kill more tumor cells. This phase I/II trial is studying the side effects and best dose of pertuzumab when given together with cetuximab and to see how well they work in treating patients with previously treated locally advanced or metastatic colorectal cancer |
>Trial ID | >Title | >Status | >Sponsor | >Phase | >Start Date | >Summary |
Clinical Trial Conditions for pertuzumab
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Clinical Trial Locations for pertuzumab
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Clinical Trial Progress for pertuzumab
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Clinical Trial Sponsors for pertuzumab
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