Viewing Study NCT00073528



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Last Modification Date: 2024-10-26 @ 9:09 AM
Study NCT ID: NCT00073528
Status: COMPLETED
Last Update Posted: 2021-02-24
First Post: 2003-11-24

Brief Title: Study Comparing Lapatinib GW572016 And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
Sponsor: Novartis Pharmaceuticals
Organization: Novartis

Study Overview

Official Title: A Randomized Double-Blind Placebo-Controlled Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With EstrogenProgesterone Receptor- Positive Advanced or Metastatic Breast Cancer
Status: COMPLETED
Status Verified Date: 2021-02
Last Known Status: None
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: This study evaluated and compared the efficacy and tolerability of lapatinib and letrozole with letrozole and placebo in post-menopausal women with hormone receptor positive ER positive andor PgR positive advanced or metastatic breast cancer who had not received prior therapy for advanced or metastatic disease
Detailed Description: Subjects were randomly assigned to receive either lapatinib 1500 mg once daily orally with letrozole 25 mg once daily orally or letrozole 25 mg once daily orally with placebo which matched with lapatinib tablet Randomization was stratified by site of disease ie soft tissuevisceral disease versus bone only disease and time since prior adjuvant endocrine therapy 6 months or 6 months from discontinuation of adjuvant anti-estrogen therapy eg tamoxifen or raloxifene or no prior adjuvant antiestrogen therapy Study therapy was administered daily until disease progression objective or symptomatic or withdrawal from therapy eg due to unacceptable toxicity withdrawal of consent or other reason All subjects were to be followed for survival information until death

On 13 Apr 2015 after the introduction of the Long Term Follow UP LTFU phase per protocol amendment 07 subjects receiving study treatment with lapatinib plus letrozole or letrozole plus placebo had continued access to this study treatment until the occurrence of one of the following criteria

Disease progression as determined by the Investigator
Intercurrent illness that prevented further administration of study treatment
Drug related AE which was considered by the investigator to warrant permanent discontinuation of study treatment
The subject decided to withdraw from the study Investigators collected AEs andor SAEs related to study participation until 30 days following study treatment discontinuation Subjects who were being followed-up for OS but were not taking study medication were withdrawn from the study

The study was terminated on 22-Mar-2018 last subject last visit

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: True
Is a FDA Regulated Device?: False
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None
Secondary IDs
Secondary ID Type Domain Link
2004-003928-35 EUDRACT_NUMBER Novartis None
CLAP016A2308 OTHER None None