EUCTR2010-019577-16-LT
Active, not recruiting
Not 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
Overview
- Phase
- Not Applicable
- Intervention
- Not specified
- Conditions
- Not specified
- Sponsor
- GlaxoSmithKline Research & Development Ltd
- Enrollment
- 525
- Status
- Active, not recruiting
- Last Updated
- 11 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
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
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the study:
- •1\. History of another malignancy.
- •Exception: Subjects who have been disease\-free for 5 years, or subjects with a
- •history of completely resected non\-melanoma skin cancer or successfully treated
- •in situ carcinoma are eligible.
- •2\. Subjects with extensive symptomatic visceral disease including hepatic
- •involvement and pulmonary lymphangitic spread of tumor, or the disease is
- •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 to:
Outcomes
Primary Outcomes
Not specified
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