A pharmacodynamics pre-surgical study of LEE011 in early breast cancer patients

Phase 1

• Conditions: HR+, HER2- early breast cancer; Therapeutic area: Diseases [C] - Cancer [C04]

• Registration Number: EUCTR2013-002588-24-FR
• Lead Sponsor: ovartis Pharma AG

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2013-12-10
• Last Update Posted: 22 August 2016

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 120

Inclusion Criteria

1. Patient is = 18 years old at the time of informed consent, with newly
diagnosed resectable breast cancer, who received no prior therapy for
breast cancer.
2. Patient is postmenopausal. Postmenopausal status is defined either
by:
• Prior bilateral oophorectomy
• Age =60
• Age <60 and amenorrhea for 12 or more months and FSH and
estradiol in the postmenopausal range.
3. Patient has a histologically (and/or cytologically) confirmed diagnosis
of estrogen-receptor positive and/or progesterone receptor positive
breast cancer by local laboratory.
4. Patient has a grade II or grade III invasive breast cancer
5. Patient has HER2 negative breast cancer defined as a negative in situ
hybridization test or an IHC status of 0, 1+ or 2+ (if IHC 2+, a negative
in situ hybridization (respectively FISH/CISH/SISH) test is required) by
local laboratory testing
6. Patient has at least one breast lesion with a diameter of =1.5 cm by
ultrasound.
7. Patient has an Eastern Cooperative Oncology Group (ECOG)
performance status 0 or 1
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 30
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 90

Exclusion Criteria

1. Patient has received any prior therapy for breast cancer.
2. Patient has a concurrent malignancy or malignancy within 3 years of
randomization, with the exception of adequately treated, basal or
squamous cell carcinoma, non-melanomatous skin cancer or
curatively resected cervical cancer.
3. Patient has active cardiac disease or a history of cardiac dysfunction
including any of the following:
• History of angina pectoris, symptomatic pericarditis, or myocardial
infarction within 12 months prior to study entry
• History of documented congestive heart failure (New York Heart
Association functional classification III-IV)
• Documented cardiomyopathy
• Patient has a Left Ventricular Ejection Fraction (LVEF) < 50% as
determined by Multiple Gated acquisition (MUGA) scan or
echocardiogram (ECHO)
• History of ventricular, supraventricular, nodal arrhythmias, or any
other cardiac arrhythmias, Long QT Syndrome or conduction
abnormality in the previous 12 months.
• Family history of QTc prolongation or of unexplainable sudden
death at <50 years of age.
• On screening 12 lead ECG, any of the following cardiac
parameters: bradycardia (heart rate < 50 at rest), tachycardia
(heart rate > 90 at rest), PR interval > 220 msec, QRS interval
>109 msec, or QTcF >450 msec.
• Systolic blood pressure >160 mmHg or <90 mmHg.
4. Patient is currently receiving any of the following medications (see
Appendix 1 for details):
• That are known strong inducers or inhibitors of CYP3A4.
• That have a narrow therapeutic window and are predominantly
metabolized through CYP3A4.
• That have a known risk to prolong the QT interval or induce
Torsades de Pointes.

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified