EUCTR2010-019577-16-IEActive, not recruitingNot Applicable
A Phase III trial to compare the safety and efficacy of lapatinib plus trastuzumab plus an aromatase inhibitor (AI) versus trastuzumab plus an AI versus lapatinib plus an AI as first- or second-line therapy in postmenopausal subjects with hormone receptor positive, HER2-positive metastatic breast cancer (MBC) who have received prior trastuzumab and endocrine therapies - N/A
GlaxoSmithKline Research & Development Ltd0 sites525 target enrollmentStarted: November 9, 2010Last updated:
Drugs
Trial Snapshot
- Phase
- Not Applicable
- Status
- Active, not recruiting
- Enrollment
- 525
Study Overview
Brief Summary
No summary available.
Study Design
- Study Type
- Interventional clinical trial of medicinal product
Eligibility Criteria
- Sex
- Female
Inclusion Criteria
- •Refer to the authorized prescribing information for lapatinib [TYKERB
- •Package Insert, 2010], trastuzumab [HERCEPTIN Package Insert, 2009],
- •letrozole [FEMARA Package Insert, 2010], anastrozole [ARIMIDEX
- •Package Insert, 2009], and exemestane [AROMASIN Package Insert, 2008] for specific information regarding warnings, precautions,
- •contraindications, adverse events, and other pertinent information on
- •the study treatment(s) that may impact subject eligibility.
- •Subjects eligible for enrollment in the study must meet all of the
- •following criteria:
- •1. Signed written informed consent. In Korea and Japan, subjects who are between
- •=18 and <20 years of age must also have a legal representative sign the
- •written informed consent.
- •2. Post-menopausal female subjects =18 years of age. Post-menopausal
- •as defined by any of the following:
- •Subjects at least 60 years of age.
- •Subjects under 60 years of age and amenorrhic for at least 12
- •consecutive months AND follicle-stimulating hormone (FSH) and
- •estradiol levels in postmenopausal range (utilizing ranges from the local
- •laboratory facility).
- •Prior bilateral oophorectomy.
- •Prior radiation castration with amenorrhea for at least 6 months
- •3. Subjects must have a history of histologically confirmed breast cancer,
- •with a clinically confirmed diagnosis of metastatic disease [confirmed by
- •histology, cytology or other clinical means (e.g. CT, MRI)]. Subjects may
- •have either measurable or non-measurable disease per Response
- •Evaluation Criteria in Solid Tumors (RECIST 1.1) [Eisenhauer, 2009]
- •4. Tumors that are ER+ and/or PgR+ by local laboratory
- •5. Documentation of HER2 overexpression or gene amplification, in the
- •invasive component of either the primary tumor or metastatic disease
- •site as defined as:
- •3+ by Immunohistochemistry (IHC)
- •HER2/neu gene amplification by fluorescence, chromogenic or silver in
- •situ hybridization [FISH, CISH or SISH; >6 HER2/neu gene copies per
- •nucleus or a FISH, CISH or SISH test ratio (HER2 gene copies to
- •chromosome 17 signals) of =2.0]
- •6. Subject must have received at least one prior regimen containing
- •trastuzumab in
- •combination with chemotherapy for breast cancer:.
- •Subject has ONLY received prior trastuzumab in combination with
- •chemotherapy as neoadjuvant and/or adjuvant treatment.
- •Subject has received ONE prior trastuzumab-containing regimen for
- •metastatic disease (and has progressed), and may or may not have
- •received prior trastuzumab in combination with chemotherapy as
- •neoadjuvant and/or adjuvant treatment.
- •7. Subject must have received prior endocrine therapy (such as
- •aromatase inhibitors or selective estrogen receptor modulators).
- •8. Subjects who have a life expectancy of > 6 months as assessed by the
- •treating investigator
- •Subjects must have baseline Left Ventricular Ejection Fraction (LVEF)
- •=50% measured by echocardiography (ECHO) or multi-gated acquisition
- •scan (MUGA)
- +10 more not shown
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the
- •1. History of another malignancy.
- •Exception: Subjects who have been disease-free for 5 years, or subjects
- •history of completely resected non-melanoma skin cancer or successfully
- •in situ carcinoma are eligible.
- •2. Subjects with extensive symptomatic visceral disease including
- •involvement and pulmonary lymphangitic spread of tumor, or the
- •considered by the investigator to be rapidly progressing or life
- •threatening
- •(subjects who are intended for chemotherapy)
- •3. Serious cardiac illness or medical condition including but not confined
- •. Uncontrolled arrhythmias
- •. Uncontrolled or symptomatic angina
- •. History of congestive heart failure (CHF)
- •. Documented myocardial infarction <6 months from study entry
- •4. Known history of, or clinical evidence of, central nervous system
- •metastases or leptomeningeal carcinomatosis
- •5. Have acute or currently active/requiring anti-viral therapy hepatic or biliary disease (with
- •the exception of subjects with Gilbert's syndrome,
- •asymptomatic
- •gallstones, liver metastases or stable chronic liver disease per
- •investigator assessment)
- •6. Have a concurrent disease or condition that may interfere with study
- •participation,
- •or any serious medical disorder that would interfere with the subject's
- •safety (for
- •example, active or uncontrolled infection or any psychiatric condition
- •prohibiting
- •understanding or rendering of informed consent)
- •7. Have any clinically significant gastrointestinal abnormalities that may
- •absorption such as malabsorption syndrome or major resection of the
- •stomach or bowels
- •8. Have a known immediate or delayed hypersensitivity reaction or
- •idiosyncrasy to drugs chemically related to any of the study agents or their excipients
- •that, in the
- •opinion of the Investigator or GSK medical monitor, contraindicates their
- •participation
- •9. Any prohibited medication as described in Section 6.2.
- •10. Administration of an investigational drug within 30 days or 5 half-
- •whichever is longer, preceding the first dose of study treatment.
Investigators
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