A Randomized, Double-blind, Multicenter, Placebo-controlled Study of Adjuvant Lapatinib in Women with Early-Stage ErbB2 Overexpressing Breast Cancer - TEACH Study

• Conditions: Early Stage Breast Cancer; MedDRA version: 8.1Level: PTClassification code 10057654Term: Breast cancer female

• Registration Number: EUCTR2005-005186-10-IT
• Lead Sponsor: GlaxoSmithKline

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2006-11-23
• Last Update Posted: 26 August 2013

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: Female
• Target Recruitment: 3000

Inclusion Criteria

1. Have histologically or cytologically confirmed ErbB2-overexpressing invasive carcinoma Tx or T1-4 of the breast at the time of the initial diagnosis and have undergone adequate excision of tumor; 2.ad tumors that overexpress ErbB2 - 3. Using the American Joint Committee on Cancer 6th edition staging criteria for breast cancer Greene, 2002 refer to Section 14.3, Appendix 3 , a woman must have Stage I through Stage IIIb disease - 4. Women with synchronous bilateral invasive breast cancer or synchronous DCIS of either the contralateral or ipsilateral breast at the time of the initial diagnosis are also eligible- 5. Have completed all primary adjuvant chemotherapy regimens prior to study enrollment. However, adjuvant endocrine therapy and radiotherapy may continue as described in Inclusion Criteria 11 and 13- 7. Have clinical and radiologic assessments that are negative for local or regional recurrence of disease or metastatic disease at the time of study entry - 9. Have undergone either total mastectomy OR lumpectomy - 16.Have a cardiac ejection fraction within institutional range of normal as measured by either echocardiogram or multigated acquisition MUGA scans. -
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range

Exclusion Criteria

1. Have clinical and radiologic evidence of local or regional recurrence of disease or metastatic disease at the time of study entry; 2. Had metachronous invasive breast cancer breast cancers diagnosed at different times ; 3. Have a prior history of other breast cancer malignancies, including DCIS; 4. Are unable to provide archived tumor tissue samples for assay; 5. Had prior therapy with an ErbB1 and/or ErbB2 inhibitor; 7. Have unresolved or unstable, serious toxicity from prior administration of another investigational drug and/or of prior cancer treatment; 8. Have malabsorption syndrome, disease significantly affecting gastrointestinal function, or resection of the stomach or small bowel. Women with ulcerative colitis are also excluded; 12. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF;

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified