Status:
COMPLETED
Evaluating the Effect of Candesartan vs Placebo in Prevention of Trastuzumab-associated Cardiotoxicity
Lead Sponsor:
The Netherlands Cancer Institute
Collaborating Sponsors:
AstraZeneca
Roche Pharma AG
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-79 years
Phase:
PHASE3
Brief Summary
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 tra...
Detailed Description
Prospective, randomized pharmacological intervention study Primary objectives: \- to determine whether concurrent ATII-antagonist treatment can prevent trastuzumab-related cardiotoxicity, defined as...
Eligibility Criteria
Inclusion
- 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
- 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
Key Trial Info
Start Date :
June 1 2007
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2014
Estimated Enrollment :
210 Patients enrolled
Trial Details
Trial ID
NCT00459771
Start Date
June 1 2007
End Date
December 1 2014
Last Update
December 2 2014
Active Locations (19)
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1
Jeroen Bosch Hospital
's-Hertogenbosch, Netherlands
2
Medisch Centrum Alkmaar
Alkmaar, Netherlands
3
Flevoziekenhuis
Almere Stad, Netherlands
4
The Netherlands Cancer Institute
Amsterdam, Netherlands, 1066 CX