EUCTR2010-019577-16-HU
Active, not recruiting
Phase 1
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
ConditionsHER2-positive metastatic breast cancer who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant settingMedDRA version: 19.0Level: PTClassification code 10065430Term: HER-2 positive breast cancerSystem Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- HER2-positive metastatic breast cancer who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant setting
- Sponsor
- ovartis Pharma Services AG
- Enrollment
- 345
- Status
- Active, not recruiting
- Last Updated
- 4 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.
- •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:
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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