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| ID | Type | Description | Link |
|---|---|---|---|
| 2014-002048-42 | EudraCT Number | ||
| 2023-505102-42-00 | Registry Identifier | CTIS (EU) |
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This is a single-arm, multi-center, open-label extension study designed to provide continued pertuzumab therapy to patients receiving pertuzumab as an investigational medicinal product (IMP) in a Roche-sponsored global study and who continue to receive pertuzumab at the end of the Parent study, as well as to collect long-term safety and efficacy data of pertuzumab therapy. Patients with solid tumors who have not experienced progressive disease in the Parent study and, in the investigator's opinion, may potentially benefit from continued pertuzumab treatment, will continue to receive pertuzumab until disease progression, unacceptable toxicity, investigator/patient decision, patient non-compliance, patient death, patient request to withdraw, or study termination by the Sponsor, whichever occurs first.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pertuzumab (Single-Agent or Combination Therapy) | Experimental | Pertuzumab will continue to be administered as a single agent or in combination with other anti-cancer therapies at the same dose, schedule, and guidelines that were in effect at the end of the Parent study. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pertuzumab | Drug | In general, patients will continue to receive 420 milligrams (mg) of pertuzumab administered as an intravenous infusion every 3 weeks following the guidance of the Parent protocol. |
| Measure | Description | Time Frame |
|---|---|---|
| Progression-Free Survival | From date of first dose of pertuzumab in this study until the date of disease progression or death, whichever occurs first (up to approximately 10 years) | |
| Overall Survival | From date of first dose of pertuzumab in this study until the date of death (up to approximately 10 years) | |
| Number of Participants with Adverse Events by Severity, Classified According to the National Cancer Institute Common Terminology Criteria for Adverse Events (NCI-CTCAE) Version 4.03 | From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years) | |
| Number of Participants with Adverse Events Leading to Pertuzumab Discontinuation or Dose Interruption | From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years) | |
| Number of Participants with Non-Serious Adverse Events of Special Interest (AESIs) | Non-serious AESIs for this study include the following: Cases of potential drug-induced liver injury that include an elevated alanine aminotransferase (ALT) or aspartate aminotransferase (AST) in combination with either an elevated bilirubin or clinical jaundice, as defined by Hy's law; Suspected transmission of an infectious agent by the study drug; or, An asymptomatic decline in left ventricular ejection fraction (LVEF) requiring treatment or leading to discontinuation of human epidermal growth factor receptor 2 (HER2)-targeted therapies. | From Baseline until 7 months after the last dose of pertuzumab (up to approximately 10 years) |
| Left Ventricular Ejection Fraction (LVEF) Over Time | Baseline, every 3 treatment cycles (1 cycle is 21 days), and 28 days after last dose of pertuzumab (up to approximately 10 years) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Clinical Trials | Hoffmann-La Roche | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Santa Casa de Misericordia de Porto Alegre | Porto Alegre | Rio Grande do Sul | 90050-170 | Brazil | ||
| Hospital Amaral Carvalho |
For eligible studies, qualified researchers may request access to individual patient level clinical data. See Roche's commitment to transparency of clinical study information here: https://go.roche.com/data\_sharing
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|
| Trastuzumab | Drug | If trastuzumab intravenous infusions were given in combination with pertuzumab as part of the Parent study, patients will continue to receive treatment at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure. |
|
| Other Combination Anti-Cancer Therapies | Drug | If other anti-cancer therapies were given in combination with pertuzumab as part of the Parent study, patients will receive all treatments at the same dose, schedule and under the same administration guidelines which were in effect at the time of Parent study closure. |
|
| Jaú |
| São Paulo |
| 17210-080 |
| Brazil |
| Instituto do Cancer do Estado de Sao Paulo - ICESP | São Paulo | São Paulo | 01246-000 | Brazil |
| Hospital Sírio-Libanês | São Paulo | São Paulo | 01308-050 | Brazil |
| Hospital Perola Byington | São Paulo | São Paulo | 01317-000 | Brazil |
| Núcleo de Pesquisa São Camilo | São Paulo | São Paulo | 04014-002 | Brazil |
| Instituto de Oncologia de Sorocaba - CEPOS | Sorocaba | São Paulo | 18030-005 | Brazil |
| Instituto Nacional de Cancer - INCa | Rio de Janeiro | 20560-120 | Brazil |
| Beijing Cancer Hospital | Beijing | 100142 | China |
| The First Hospital of Jilin University | Changchun | 130021 | China |
| West China Hospital, Sichuan University | Chengdu | 610041 | China |
| Zhejiang Cancer Hospital | Hangzhou | 310022 | China |
| Harbin Medical University Cancer Hospital | Harbin | 150081 | China |
| Jiangsu Province Hospital (the First Affiliated Hospital With Nanjing Medical University) | Nanjing | 210029 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200032 | China |
| Fudan University Shanghai Cancer Center | Shanghai | 200120 | China |
| Liaoning cancer Hospital & Institute | Shenyang | 110042 | China |
| Hospital Metropolitano (Sede Lindora-Santa Ana) | San José | 10903 | Costa Rica |
| Centre Georges Francois Leclerc | Dijon | 21079 | France |
| Centre Henri Becquerel | Rouen | 76038 | France |
| Clinique Armoricaine Radiologie | Saint-Brieuc | 22015 | France |
| Centre Rene Huguenin | Saint-Cloud | 92210 | France |
| Hämatologisch-Onkologische Gemeinschaftspraxis am Bethanien-Krankenhaus | Frankfurt am Main | 60389 | Germany |
| Praxis für Interdisziplinäre Onkologie und Hämatologie GbR | Freiburg im Breisgau | 79110 | Germany |
| Praxis für Ambulante Onkologie im Krankenhaus Jerusalem | Hamburg | 20357 | Germany |
| Studienzentrum UnterEms;Onkologische Schwerpunktpraxis Leer | Leer | 26789 | Germany |
| Onkologische Praxis Neumarkt (Dr. med. Ekkehart Ladda) | Neumarkt | 92318 | Germany |
| Irccs Ist. Tumori Giovanni Paolo Ii | Bari | Apulia | 70124 | Italy |
| Az. Osp. S. Orsola Malpighi | Bologna | Emilia-Romagna | 40138 | Italy |
| IRST Istituto Scientifico Romagnolo Per Lo Studio E Cura Dei Tumori, Sede Meldola | Meldola | Emilia-Romagna | 47014 | Italy |
| AUSL ? IRCCS Santa Maria Nuova | Reggio Emilia | Emilia-Romagna | 42100 | Italy |
| Irccs Istituto Europeo Di Oncologia (IEO) | Milan | Lombardy | 20141 | Italy |
| Asst Di Monza | Monza | Lombardy | 20052 | Italy |
| A.O. Universitaria Pisana | Pisa | Tuscany | 56100 | Italy |
| National Cancer Center Hospital East | Chiba | 277-8577 | Japan |
| Gifu University Hospital | Gifu | 501-1194 | Japan |
| Saitama Cancer Center | Saitama | 362-0806 | Japan |
| Iem-Fucam | D.F. | Mexico CITY (federal District) | 04980 | Mexico |
| Cancerologia de Queretaro | Querétaro City | Querétaro | 76090 | Mexico |
| Instituto Nacional de Cancerologia | Distrito Federal | 14080 | Mexico |
| Hospital Nacional Carlos Alberto Seguin Escobedo-Essalud | Arequipa | 04001 | Peru |
| Clinica Anglo Americana - Centro de Investigacion Oncologia CAA | Lima | L27 | Peru |
| Clinica Internacional, Sede San Borja | Lima | Lima 41 | Peru |
| Samodzielny Publiczny Kliniczny Nr 1 W Lublinie | Lublin | 20-081 | Poland |
| IPO de Coimbra | Coimbra | 3000-075 | Portugal |
| Hospital da Luz | Lisbon | 1500-650 | Portugal |
| Hospital de Santa Maria | Lisbon | 1649-035 | Portugal |
| IPO do Porto | Porto | 4200-072 | Portugal |
| Kursk Regional Clinical Oncology Dispensary | Kursk | 305035 | Russia |
| SBI of Healthcare Samara Regional Clinical Oncology Dispensary | Samara | 443031 | Russia |
| Seoul National University Hospital | Seoul | 03080 | South Korea |
| Severance Hospital, Yonsei University Health System | Seoul | 03722 | South Korea |
| Asan Medical Center | Seoul | 05505 | South Korea |
| ICO L'Hospitalet | L'Hospitalet de Llobregat | Barcelona | 08908 | Spain |
| Hospital Universitario Marques de Valdecilla | Santander | Cantabria | 39008 | Spain |
| Hospital Universitario de Canarias | San Cristóbal de La Laguna | Tenerife | 38320 | Spain |
| Hospital de Basurto | Bilbao | Vizcaya | 48013 | Spain |
| Vall d'Hebron Institute of Oncology (VHIO), Barcelona | Barcelona | 08035 | Spain |
| Hospital Universitari i Politecnic La Fe | Valencia | 46026 | Spain |
| Mun. Multifield Clin.Hosp.#4,Dept. of Chemotherapy, DSMU | Dnipropetrovsk | 49102 | Ukraine |
| State Oncology Regional Treatment-Diagnostic Center | Lviv | 79031 | Ukraine |
| ID | Term |
|---|---|
| C485206 | pertuzumab |
| D000068878 | Trastuzumab |
| ID | Term |
|---|---|
| D061067 | Antibodies, Monoclonal, Humanized |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
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