EUCTR2010-019577-16-NO
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-line therapy in postmenopausal subjects with hormone receptorpositive, HER2-positive metastatic breast cancer (MBC) who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting - 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
- 13 years ago
Overview
Brief Summary
No summary available.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Subjects eligible for enrollment in the study must meet all of the following criteria:
- •1\. Signed written informed consent
- •2\. Post\-menopausal female subjects \=18 years of age. Post\-menopausal as defined
- •by any of the following:
- •Age \> 60 years
- •Age \= 45 years with amenorrhea \> 12 months with an intact uterus
- •Having undergone a bilateral oophorectomy or radiation castration with
- •amenorrhea for at least 6 months
- •FSH and estradiol levels in postmenopausal range (utilizing ranges from the
- •local laboratory facility). In subjects who have previously been treated with
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\. Subjects who received prior chemotherapy, hormonal therapy, immunotherapy,
Outcomes
Primary Outcomes
Not specified
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