- ICH GCP
- Rejestr badań klinicznych w USA
- Badanie kliniczne NCT02571894
The Cardio-Oncology Breast Cancer Study (COBC)
Effects of Identifying and Treating Early, Subclinical Cardiotoxicity on the Long-Term Incidence of Clinical Cardiotoxicity in Women With Breast Cancer, A Prospective Randomized Study: The Cardio-Oncology Breast Cancer Study (COBC)
Przegląd badań
Status
Interwencja / Leczenie
Szczegółowy opis
Rationale for the study:
Breast cancer is the most common cancer among Swedish women, accounting for a third of all cancer cases among females. The breast cancer incidence has increased from 2596 to more than 8000 breast cancer diagnosis 2011. During the past 40 years, the age-adjusted incidence has doubled. Early adjuvant therapy reduces the risk of dying with about 50%. (Early adjuvant therapies; chemotherapy, antibodies, endocrine therapy, and radiotherapy). Treatment advances have improved survival rates, but treatment-related cardiotoxicity (CT) remains a substantial problem.
In general, earlier treatment of cardiotoxicity offers the best chances of preventing or ameliorating clinical cardiotoxicity. Risk factors should be modified or reduced by treating elevated blood pressure, normalizing lipids, encouraging weight reduction and smoking cessation. Patient-tailored therapy is now possible, especially given the availability of different chemotherapy regimens, safer anthracycline analogs such as liposomal doxorubicin, and cardioprotective medications such as angiotensin converting enzyme (ACE)-inhibitors, angiotensin receptor blockers, and b-blockers. It is now suggested that new cardiac biomarkers and ultrasound techniques can detect cardiotoxicity in its early, subclinical, stages. The investigators hypothesized that biomarkers can be used to detect subclinical cardiotoxicity and that detecting early signs of cardiotoxicity might reduce the number, time-to-onset, and severity of cardiotoxic events.
In present proposal the investigators aim in a randomized study to compare primary cardiac preventive measurements versus standard care.
Objectives of the trial:
- Primary objective In a randomized study to investigate the cumulative incidence of cardiotoxic events, per randomized arm, before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of the chemotherapy.
- Secondary Objectives To compare the number, time-to-onset, and severity of cardiotoxic events in an experimental group assessed and treated for subclinical cardiotoxicity before start of chemotherapy, during treatment and at 1, 5, and 10 years after the completion of the chemotherapy and a control group receiving standard of care without early assessment for subclinical cardiotoxicity. Data on the same variables will be collected from both groups before start of chemotherapy, during treatment and at 1, 5, and 10 years. Data from the experimental group will be used in real time to guide therapy, but data from the control group will be not be analyzed until after the end of the study.
To assess subclinical cardiotoxicity with serum concentrations of biomarkers, tissue Doppler and strain echocardiography, electrocardiography, and magnetic resonance imaging, as well as with standard cardiac risk assessment based on standard risk factors: a history of heart disease, increasing age, obesity, hypertension, diabetes mellitus, hypercholesterolemia, smoking, parasternal radiotherapy, and the cumulative dose of anthracyclines and trastuzumab.
To assess the association between primary treatment of existing standard cardiac risk factors, biomarkers and parameters of echocardiography, electrocardiography, and cardiac magnetic resonance imaging, (predictors) and subsequent occurrence of clinical or subclinical cardiotoxicity of cardiotoxicity (outcome) within and between-groups, over time.
To examine how a diagnosis of breast cancer and the development of cardiotoxicity influences women's quality of life.
Typ studiów
Zapisy (Oczekiwany)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Stockholm, Szwecja, 171 76
- Karolinska University Hospital
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
Inclusion Criteria:
- Women with newly diagnosed breast cancer who are eligible to receive neo-adjuvant or adjuvant chemotherapy, with or without trastuzumab, according to the guidelines for breast cancer.
- Written informed consent must be given.
Exclusion Criteria:
- A history of heart disease; ischemic heart disease, arrhythmias, heart failure, and valve diseases.
- Previously received oncological treatment for any malignancy.
- Other disease or conditions that complicates or precludes the patient from following the study protocol.
Plan studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Zapobieganie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Brak (otwarta etykieta)
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
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Brak interwencji: Observational arm
Participants randomized to observational arm will receive standard oncological followup and care.
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Eksperymentalny: Intervention arm
Intervention arm receives standard oncological followup and care + subclinical cardiotoxicity surveillance and treatment.
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Intervention arm receives cardiology assessment and intervention.
Inne nazwy:
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Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
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Event free survival
Ramy czasowe: 1 year after the completion of the chemotherapy.
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The cumulative incidence of clinical or subclinical cardiotoxicity, per randomized arm, in women with breast cancer at 1 year after treatment with neo- or adjuvant chemotherapy.
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1 year after the completion of the chemotherapy.
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Miary wyników drugorzędnych
Miara wyniku |
Ramy czasowe |
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Event free survival
Ramy czasowe: 5 and 10 years after the completion of the chemotherapy.
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5 and 10 years after the completion of the chemotherapy.
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Overall survival
Ramy czasowe: 1, 5 and 10 years after the completion of the chemotherapy.
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1, 5 and 10 years after the completion of the chemotherapy.
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The levels of serum biomarkers (hs-Troponin T (hs-TnT), B-type natriuretic peptide (BNP)).
Ramy czasowe: 1, 5 and 10 years after the completion of the chemotherapy.
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1, 5 and 10 years after the completion of the chemotherapy.
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Echocardiographic global longitudinal strain
Ramy czasowe: 1, 5 and 10 years after the completion of the chemotherapy.
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1, 5 and 10 years after the completion of the chemotherapy.
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The quality of life
Ramy czasowe: 1, 5 and 10 years after the completion of the chemotherapy.
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1, 5 and 10 years after the completion of the chemotherapy.
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Współpracownicy i badacze
Sponsor
Śledczy
- Główny śledczy: Elham Hedayati, MD, PhD, Karolinska University Hospital
- Główny śledczy: Laila Hubbert, MD, PhD, University Hospital, Linkoeping
Publikacje i pomocne linki
Publikacje ogólne
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- Ky B, Putt M, Sawaya H, French B, Januzzi JL Jr, Sebag IA, Plana JC, Cohen V, Banchs J, Carver JR, Wiegers SE, Martin RP, Picard MH, Gerszten RE, Halpern EF, Passeri J, Kuter I, Scherrer-Crosbie M. Early increases in multiple biomarkers predict subsequent cardiotoxicity in patients with breast cancer treated with doxorubicin, taxanes, and trastuzumab. J Am Coll Cardiol. 2014 Mar 4;63(8):809-16. doi: 10.1016/j.jacc.2013.10.061. Epub 2013 Nov 27. Erratum In: J Am Coll Cardiol. 2016 Mar 22;67(11):1385.
- Suter TM, Procter M, van Veldhuisen DJ, Muscholl M, Bergh J, Carlomagno C, Perren T, Passalacqua R, Bighin C, Klijn JG, Ageev FT, Hitre E, Groetz J, Iwata H, Knap M, Gnant M, Muehlbauer S, Spence A, Gelber RD, Piccart-Gebhart MJ. Trastuzumab-associated cardiac adverse effects in the herceptin adjuvant trial. J Clin Oncol. 2007 Sep 1;25(25):3859-65. doi: 10.1200/JCO.2006.09.1611. Epub 2007 Jul 23.
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- Ewer MS, Swain SM, Cardinale D, Fadol A, Suter TM. Cardiac dysfunction after cancer treatment. Tex Heart Inst J. 2011;38(3):248-52.
- Harbeck N, Ewer MS, De Laurentiis M, Suter TM, Ewer SM. Cardiovascular complications of conventional and targeted adjuvant breast cancer therapy. Ann Oncol. 2011 Jun;22(6):1250-1258. doi: 10.1093/annonc/mdq543. Epub 2010 Nov 26.
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- Fallah-Rad N, Walker JR, Wassef A, Lytwyn M, Bohonis S, Fang T, Tian G, Kirkpatrick ID, Singal PK, Krahn M, Grenier D, Jassal DS. The utility of cardiac biomarkers, tissue velocity and strain imaging, and cardiac magnetic resonance imaging in predicting early left ventricular dysfunction in patients with human epidermal growth factor receptor II-positive breast cancer treated with adjuvant trastuzumab therapy. J Am Coll Cardiol. 2011 May 31;57(22):2263-70. doi: 10.1016/j.jacc.2010.11.063.
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- Garrone O, Crosetto N, Lo Nigro C, Catzeddu T, Vivenza D, Monteverde M, Merlano M, Feola M. Prediction of anthracycline cardiotoxicity after chemotherapy by biomarkers kinetic analysis. Cardiovasc Toxicol. 2012 Jun;12(2):135-42. doi: 10.1007/s12012-011-9149-4.
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Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Oczekiwany)
Ukończenie studiów (Oczekiwany)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Rzeczywisty)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- COBC
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