Tykerb Evaluation After Chemotherapy (TEACH): Lapatinib Versus Placebo In Women With Early-Stage Breast Cancer

Conditions

• Neoplasms, Breast

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• lapatinib — DRUG
  Lapatinib 1500 mg (6 tablets) daily for 12 months
• placebo — OTHER
  6 tablets daily for 12 months

Study Details

This study was designed to evaluate and compare the safety and efficacy of an oral dual tyrosine kinase inhibitor, lapatinib, versus placebo in women with early-stage ErbB2-overexpressing breast cancer who have completed their primary neoadjuvant or adjuvant chemotherapy and have no clinical or radiographic evidence of disease.

Key Dates

Start date

Aug 31, 2006

Status verified

Jul 2014

Primary completion

Sep 30, 2011

Completion

Jul 31, 2013

Study Design

Enrollment

3,166 participants (actual)

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Arms

• Placebo Comparator: Placebo
  6 tablets daily for 12 months
• Experimental: Lapatinib
  Lapatinib 1500 mg (6 tablets) daily for 12 months

Primary Outcome Measure

Number of Participants (Par.) With Any Recurrence of the Initial Disease, Second Primary Cancer, Contralateral Breast Cancer, or Death (Disease-free Survival [DFS]) [ Time Frame: From randomization until date of the first occurrence of an objective disease recurrence, a second primary cancer, or death from any cause (assessed up to 6 years; 1 year of treatment, 5 years of follow-up [median of 5.3 years for final analysis]) ]

Locations (103)

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