EUCTR2010-019577-16-IE
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
Exclusion Criteria
- •Subjects meeting any of the following criteria must not be enrolled in the
- •1\. History of another malignancy.
- •Exception: Subjects who have been disease\-free for 5 years, or subjects
- •history of completely resected non\-melanoma skin cancer or successfully
- •in situ carcinoma are eligible.
- •2\. Subjects with extensive symptomatic visceral disease including
- •involvement and pulmonary lymphangitic spread of tumor, or the
- •considered by the investigator to be rapidly progressing or life
- •threatening
- •(subjects who are intended for chemotherapy)
Outcomes
Primary Outcomes
Not specified
Similar Trials
Active, not recruiting
Phase 1
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib or trastuzumab, or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancer.EUCTR2010-019577-16-ITGLAXOSMITHKLINE RESEARCH & DEVELOPMENT LTD.525
Active, not recruiting
Not Applicable
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib or trastuzumab, or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancerHER2-positive metastatic breast cancer who have received trastuzumab and endocrine therapy in the neoadjuvant and/or adjuvant settingMedDRA version: 14.0Level: LLTClassification 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]EUCTR2010-019577-16-ESGlaxoSmithKline Research & Development Ltd525
Active, not recruiting
Phase 1
A study to compare the safety and efficacy of an aromatase inhibitor in combination with lapatinib or trastuzumab, or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancerHER2-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)Therapeutic area: Diseases [C] - Cancer [C04]EUCTR2010-019577-16-BEGlaxoSmithKline Research & Development Ltd345
Active, not recruiting
Phase 1
A study to compare the safety and efficacy of an aromatase inhibitor incombination with lapatinib or trastuzumab, or both for the treatment of hormone receptor positive, HER2+ metastatic breast cancerHER2-positive metastatic breast cancer who have received prior trastuzumab and endocrine therapiesMedDRA 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]EUCTR2010-019577-16-GBovartis Pharma Services AG345
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 settingHER2-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)EUCTR2010-019577-16-HUovartis Pharma Services AG345