Full Text View
Tabular View
No Study Results Posted
Related Studies
Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity
This study is currently recruiting participants.
Verified by The Netherlands Cancer Institute, February 2010
First Received: April 11, 2007   Last Updated: February 8, 2010   History of Changes
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

Resource links provided by NLM:


Further study details as provided by The Netherlands Cancer Institute:

Primary Outcome Measures:
  • The occurrence of cardiotoxicity, defined as a decline in LVEF (MUGA) of more than 15% or a decrease of less than 15% to an absolute value below 45%. [ Time Frame: during 1 year trastuzumab therapy and during 26 weeks after discontinuation of trastuzumab ] [ Designated as safety issue: Yes ]

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
Criteria

Inclusion Criteria:

  • Women aged ≥18 years
  • WHO: ≤ 2
  • Strongly HER2-positive breast cancer, defined as an immunohistochemistry score of 3+ using the HercepTestTM, or gene amplification by fluorescence in situ hybridization, or chromogenic in situ hybridization (CISH).
  • Serum creatinine <140 umol/l or creatinine clearance > 50 ml/min (by Cockcroft-Gault formula)
  • Thyroid stimulating hormone between 0.5-3.9 MU/l
  • Blood pressure systolic ≥ 140 mmHg and diastolic ≥ 90 mmHg is acceptable at randomization. However prior to the first administration of trastuzumab blood pressure should be regulated and should be systolic ≥ 100 mmHg and ≤ 180 mmHg and diastolic ≥ 60 mmHg and ≤ 100 mmHg. (blood pressure should be regulated according to the guidelines of appendix 5)
  • LVEF ³ 50% assessed by multigated angiography (MUGA) or cardiac ultrasound
  • Adjuvant regimen: trastuzumab start ≥ 3 weeks after day 1 of the last anthracycline chemotherapy cycle
  • Trastuzumab treatment according to standard medical care
  • Written informed consent to participate in the study

Exclusion Criteria:

  • Prior anthracycline chemotherapy regimen or anti-HER2 therapy, or other prior biologic or immunotherapy for breast cancer treatment or any malignancy
  • Previous malignancy requiring chemotherapy or radiotherapy
  • Uncontrolled serious concurrent illness
  • Patients with New York Heart Association (NYHA) class II/III/IV congestive heart failure
  • Myocardial infarction < 6 months before randomization
  • Treatment with ACE inhibitor, ATII blocker, or lithium. Patients treated with ACE inhibitor, or ATII blocker can switch (after randomization and during the chemotherapy period) to alternative antihypertensive therapy; see appendix 5.
  • History of hypersensitivity to the study medication
  • Pregnancy or breast feeding
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00459771

Contacts
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

Locations
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            
Sponsors and Collaborators
The Netherlands Cancer Institute
AstraZeneca
Roche Pharma AG
Investigators
Principal Investigator: J.H.M. Schellens, MD PhD The Netherlands Cancer Institute
  More Information

No publications provided

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)

Keywords provided by The Netherlands Cancer Institute:
angiotensin II-receptor (AT1) blocker
prevention
trastuzumab
cardiotoxicity

Additional relevant MeSH terms:
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

ClinicalTrials.gov processed this record on February 08, 2010