Continued HER2 Suppression With Lapatinib Plus Trastuzumab Versus Trastuzumab Alone

Conditions

• Cancer

Eligibility Criteria

Sex

FEMALE

Age

18 Years - N/A

Healthy Volunteers

Not accepted

Interventions

• Lapatinib — DRUG
  Oral Lapatinib 1000 mg once daily. Lapatinib was a small molecule, reversible inhibitor targeting HER2 tyrosine kinase receptor.
• Trastuzumab — BIOLOGICAL
  IV Trastuzumab 6 mg/kg every three weeks. Trastuzumab was a humanized, monoclonal antibody directed against the extracellular domain of the HER2 tyrosine kinase receptor.

Study Details

This was a randomized, open-label, multi-center Phase III study evaluating the efficacy and safety of lapatinib in combination with trastuzumab versus trastuzumab alone as continued HER2 suppression therapy in women with HER2-positive metastatic breast cancer (MBC). Eligible subjects should have completed 12 to 24 weeks of first- or second-line treatment with trastuzumab plus chemotherapy, experienced either complete disappearance of all metastatic lesions, or persistence of metastatic disease (stable disease) without unequivocal progression or the occurrence of new lesions, and been indicated to continue to receive trastuzumab alone as maintenance therapy. Eligible subjects who entered the LPT112515 study on first-line treatment should not have known history of central nervous system (CNS) metastases; subjects who entered the study on second-line treatment should not have known history of CNS metastases or have stable (asymptomatic and off steroids ≥3 months) CNS metastases. The primary objective of this study was to compare progression-free survival (PFS) in subjects with HER2-positive MBC randomized to receive treatment with lapatinib plus trastuzumab versus those randomized to receive trastuzumab alone. The secondary objectives included overall survival, clinical benefit response rate (CR, PR or SD ≥24 weeks) and the qualitative and quantitative adverse event profile of the 2 treatment arms. It was estimated that 280 subjects (140 per group) would be required to observe 193 PFS events.

Key Dates

Start date

Jan 20, 2010

Status verified

Jun 2019

Primary completion

Feb 21, 2014

Completion

Mar 30, 2018

Study Design

Enrollment

37 participants (actual)

Allocation

RANDOMIZED

Primary purpose

TREATMENT

Arms

• Experimental: Arm 1: Lapatinib plus Trastuzumab
• Active Comparator: Arm 2: Trastuzumab

Primary Outcome Measure

Progression-free Survival [ Time Frame: Time from randomization until disease progression or death, approximately 4 years ]

Locations (112)

Find similar trials in Chandler, AZ

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