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 receptorpositive, HER2-positive metastatic breast cancer (MBC) who have received trastuzumab and endocrine therapies - N/A

ovartis Pharma Services AG0 sites345 target enrollmentAugust 2, 2011

ConditionsHER2-positive metastatic breast cancer who have received prior trastuzumab and endocrine therapies MedDRA version: 20.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)Therapeutic area: Diseases [C] - Cancer [C04]

DrugsTyverb Herceptin

Overview

Phase: Phase 1
Intervention: Not specified
Conditions: HER2-positive metastatic breast cancer who have received prior trastuzumab and endocrine therapies
Sponsor: ovartis Pharma Services AG
Enrollment: 345
Status: Active, not recruiting
Last Updated: 5 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

No summary available.

Registry

who.int

Start Date

August 2, 2011

End Date

TBD

Last Updated

5 years ago

Study Type

Interventional clinical trial of medicinal product

Sex

Female

Investigators

Sponsor

ovartis Pharma Services AG

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.
•Deviations from inclusion criteria are not allowed because they can potentially jeopardize the scientific integrity of the study, regulatory acceptability or subject safety. Therefore, adherence to the criteria as specified in the protocol is essential.
•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 (utilising 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]

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: