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| Sponsor: | The Netherlands Cancer Institute |
|---|---|
| Collaborators: |
AstraZeneca Roche Pharma AG |
| Information provided by: | The Netherlands Cancer Institute |
| ClinicalTrials.gov Identifier: | NCT00459771 |
Purpose
Evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan vs placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab.
| Condition | Intervention | Phase |
|---|---|---|
|
Breast Cancer |
Drug: AT1 blocker candesartan Drug: Placebo |
Phase III |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Placebo Control, Parallel Assignment, Bio-availability Study |
| Official Title: | Prospective, Randomized, Pharmacological Intervention Study; Evaluating Effect of the Angiotensin II-receptor (AT1) Blocker Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity in Patients Treated With Trastuzumab |
| Estimated Enrollment: | 200 |
| Study Start Date: | June 2007 |
| Estimated Study Completion Date: | June 2013 |
| Estimated Primary Completion Date: | June 2013 (Final data collection date for primary outcome measure) |
| Arms | Assigned Interventions |
|---|---|
|
Placebo: Placebo Comparator
Placebo
|
Drug: Placebo
Placebo, 32 mg, oral QD
|
|
Candesartan: Active Comparator
Candasartan
|
Drug: AT1 blocker candesartan
AT1 blocker candesartan, 32 mg oral QD
|
Show Detailed Description
Eligibility| Ages Eligible for Study: | 18 Years to 79 Years |
| Genders Eligible for Study: | Female |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
Contacts and Locations| Contact: J.H.M. Schellens, MD PhD | +31 20 512 2446 | j.schellens@nki.nl |
| Contact: A. Boekhout | + 31 20 512 1035 | a.boekhout@nki.nl |
| United States, Massachusetts | |
| Beth Israel Deaconess Medical Center | Not yet recruiting |
| Boston, Massachusetts, United States, MA 02215 | |
| Contact: J. D. Chang, MD | |
| Principal Investigator: J. D. Chang, MD | |
| Netherlands | |
| University Medical Center Groningen | Recruiting |
| Groningen, Netherlands | |
| Contact: E.G.E. de Vries, MD PhD | |
| Principal Investigator: E.G.E. de Vries, Prof. MD. | |
| UMC St. Radboud | Recruiting |
| Nijmegen, Netherlands | |
| Contact: P B. Ottevanger, MD, PhD | |
| Principal Investigator: P. B. Ottevanger, MD, PhD | |
| Medisch Centrum Leeuwarden | Recruiting |
| Leeuwarden, Netherlands | |
| Contact: W.E. Fiets, MD, PhD | |
| Principal Investigator: W.E. Fiets, MD, PhD | |
| Canisius-Wilhelmina Hospital | Recruiting |
| Nijmegen, Netherlands | |
| Contact: C.M.P.W. Mandigers, MD, PhD | |
| Principal Investigator: C.M.P.W. Mandigers, MD, PhD | |
| Slotervaart Hospital | Recruiting |
| Amsterdam, Netherlands | |
| Contact: M. Soesan, MD | |
| Principal Investigator: M. Soesan, MD, PhD | |
| Isala Klinieken | Recruiting |
| Zwolle, Netherlands | |
| Contact: A. Honkoop, MD PhD | |
| Principal Investigator: A. Honkoop, MD, PhD | |
| Medisch Spectrum Twente | Recruiting |
| Enschede, Netherlands | |
| Contact: W. Smit, MD, PhD | |
| Principal Investigator: W. Smit, MD, PhD | |
| The Netherlands Cancer Institute | Recruiting |
| Amsterdam, Netherlands, 1066 CX | |
| Contact: J.H.M. Schellens, MD, PhD | |
| Principal Investigator: J.H.M. Schellens, Prof. MD. | |
| Wilhelmina Ziekenhuis | Recruiting |
| Assen, Netherlands | |
| Contact: P. Nieboer, MD, PhD | |
| Principal Investigator: P. Nieboer, MD, PhD | |
| Flevoziekenhuis | Recruiting |
| Almere, Netherlands | |
| Contact: V. Lustig, MD | |
| Principal Investigator: V. Lustig, MD | |
| Onze Lieve Vrouwe Gasthuis | Recruiting |
| Amsterdam, Netherlands | |
| Contact: B. de Valk, MD | |
| Principal Investigator: B. de Valk, MD | |
| Jeroen Bosch Hospital | Recruiting |
| Den Bosch, Netherlands | |
| Contact: T. Smilde, MD, PhD | |
| Principal Investigator: T. Smilde, MD, PhD | |
| Medisch Centrum Alkmaar | Recruiting |
| Alkmaar, Netherlands | |
| Contact: C. H. Smorenburg, MD, PhD | |
| Principal Investigator: C. H. Smorenburg, MD, PhD | |
| Martini Ziekenhuis | Recruiting |
| Groningen, Netherlands | |
| Contact: A.W.G. van der Velde, MD | |
| Principal Investigator: A.W.G. van der Velde, MD | |
| Antonius Ziekenhuis | Recruiting |
| Nieuwegein, Netherlands | |
| Contact: M. Los, MD | |
| Principal Investigator: M. Los, MD | |
| Ziekenhuis de Tjongerschans | Recruiting |
| Heerenveen, Netherlands | |
| Contact: J. de Boer, MD | |
| Principal Investigator: J. de Boer, MD | |
| Streekziekenhuis Koningin Beatrix | Recruiting |
| Winterswijk, Netherlands | |
| Contact: P.P.J.B.M.M. Schiphorst, MD | |
| Principal Investigator: P.P.J.B.M.M. Schiphorst, MD | |
| VieCuri Medisch Centrum voor Noord-Limburg | Recruiting |
| Venlo, Netherlands | |
| Contact: A. J. van der Wouw, MD, PhD | |
| Principal Investigator: A. J. van der Wouw, MD, PhD | |
| Deventer Ziekenhuis | Recruiting |
| Deventer, Netherlands | |
| Contact: L. Kessels, MD, PhD | |
| Principal Investigator: L. Kessels, MD, PhD | |
| Principal Investigator: | J.H.M. Schellens, MD PhD | The Netherlands Cancer Institute |
More Information
| Responsible Party: | NKI-AVL ( S. Rodenhuis, Prof. MD ) |
| Study ID Numbers: | M06HER, 2006-001707-11 |
| Study First Received: | April 11, 2007 |
| Last Updated: | February 8, 2010 |
| ClinicalTrials.gov Identifier: | NCT00459771 History of Changes |
| Health Authority: | Netherlands: The Central Committee on Research Involving Human Subjects (CCMO) |
|
angiotensin II-receptor (AT1) blocker prevention trastuzumab cardiotoxicity |
|
Molecular Mechanisms of Pharmacological Action Skin Diseases Antineoplastic Agents Breast Neoplasms Cardiovascular Agents Antihypertensive Agents Angiotensin II Pharmacologic Actions Angiotensin II Type 1 Receptor Blockers |
Candesartan cilexetil Neoplasms Neoplasms by Site Therapeutic Uses Candesartan Trastuzumab Vasoconstrictor Agents Breast Diseases |