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 receptor positive, HER2-positive metastatic breast cancer (MBC) who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting - N/A

GlaxoSmithKline Research & Development Ltd0 sites525 target enrollmentNovember 25, 2011

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: HER2-positive metastatic breast cancer who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting
Sponsor: GlaxoSmithKline Research & Development Ltd
Enrollment: 525
Status: Active, not recruiting
Last Updated: 13 years ago

No summary available.

Registry

who.int

Start Date

November 25, 2011

End Date

TBD

Last Updated

13 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Sponsor

•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
•2\. Post\-menopausal female subjects \>\= 18 years of age. Post\-menopausal as defined by any of the following:
•\- Age \> 60 years
•\- Age \> or 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 an GnRH/LHRH analogue, the last injection must have been administered \>4 months prior to randomization and menses must not have restarted
•3\. Histologically confirmed Stage IV invasive breast cancer
•\- Subjects may have either measurable or non\-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST 1\.1\) \[Eisenhauer, 2009]

•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, biologic therapy, or anti\-HER2 therapy for advanced or metastatic disease
•4\. Serious cardiac illness or medical condition including but not confined to:
•\- Uncontrolled arrhythmias
•\- Uncontrolled or symptomatic angina
•\- History of congestive heart failure (CHF)
•\- Documented myocardial infarction \<6 months from study entry