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Clinical Trials/EUCTR2006-001707-11-NL
EUCTR2006-001707-11-NL
Active, not recruiting
Not Applicable

Prospective, randomized, pharmacological intervention study; evaluating the effect of the angiotensin II-receptor (AT1) blocker candesartan versus placebo in prevention of trastuzumab-associated cardiotoxicity in patients with primary breast cancer treated with trastuzumab - M06HER

KI-Av0 sitesOctober 26, 2007
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ConditionsWHO: 0-2 Serum creatinine <140 umol/l Thyroid stimulating hormone between 0.5-3.9 MU/l. Blood pressure systolic = 140 mmHg diastolic = 90 mmHg is acceptable at randomization. LVEF ? 50% assessed by multigated angiography (MUGA) or cardiac ultrasound
DrugsAtacand

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
WHO: 0-2 Serum creatinine <140 umol/l Thyroid stimulating hormone between 0.5-3.9 MU/l. Blood pressure systolic = 140 mmHg diastolic = 90 mmHg is acceptable at randomization. LVEF ? 50% assessed by multigated angiography (MUGA) or cardiac ultrasound
Sponsor
KI-Av
Status
Active, not recruiting
Last Updated
12 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
October 26, 2007
End Date
TBD
Last Updated
12 years ago
Study Type
Interventional clinical trial of medicinal product
Sex
Female

Investigators

Sponsor
KI-Av

Eligibility Criteria

Inclusion Criteria

  • •Women aged \=18 years
  • •2\.WHO: 0\-2
  • •3\.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)
  • •4\.Serum creatinine \<140 umol/l or creatinine clearance \> 50 ml/min (by Cockcroft\-Gault formula)
  • •5\.Thyroid stimulating hormone between 0\.5\-3\.9 MU/l
  • •6\.Blood pressure systolic \= 140 mmHg 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\).
  • •7\.LVEF ? 50% assessed by multigated angiography (MUGA) or cardiac ultrasound.
  • •8\.(Neo\-) adjuvant regimen: trastuzumab start \= 3 weeks after day 1 of the last anthracycline chemotherapy cycle
  • •9\.Trastuzumab treatment according standard medical care
  • •10\.Written informed consent to participate in the study

Exclusion Criteria

  • •1\.Prior anthracycline chemotherapy regimen or anti\-HER2 therapy, or other prior biologic or immunotherapy for breast cancer treatment or any malignancy
  • •2\.Previous malignancy requiring chemotherapy or radiotherapy
  • •3\.Uncontrolled serious concurrent illness
  • •4\.Patients with New York Heart Association (NYHA) class III/IV congestive heart failure
  • •5\.Myocardial infarction \< 6 months before randomization
  • •6\.Treatment with ACE inhibitors, ATII blockers, or lithium. Patients treated with ACE inhibitors or ATII blockers can switch (after randomization and during the chemotherapy period) to alternative antihypertensive therapy; see appendix 5\.
  • •7\.History of hypersensitivity to the study medication
  • •8\.Pregnancy or breast feeding

Outcomes

Primary Outcomes

Not specified

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