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Trial details imported from ClinicalTrials.gov

For full trial details, please see the original record at https://clinicaltrials.gov/study/NCT00073528




Registration number
NCT00073528
Ethics application status
Date submitted
24/11/2003
Date registered
26/11/2003
Date last updated
24/02/2021

Titles & IDs
Public title
Study Comparing Lapatinib (GW572016) And Letrozole Versus Letrozole In Subjects With Advanced Or Metastatic Breast Cancer
Scientific title
A Randomized, Double-Blind, Placebo-Controlled, Multicenter Phase III Study Comparing GW572016 and Letrozole Versus Letrozole in Subjects With Estrogen/Progesterone Receptor- Positive Advanced or Metastatic Breast Cancer
Secondary ID [1] 0 0
CLAP016A2308
Secondary ID [2] 0 0
EGF30008
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Breast Neoplasms 0 0
Condition category
Condition code
Cancer 0 0 0 0
Breast

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Treatment: Drugs - Lapatinib
Treatment: Drugs - Letrozole
Treatment: Drugs - Placebo

Placebo comparator: Placebo + Letrozole 2.5 mg - Letrozole (2.5 mg once daily orally) with Placebo (which matched with Lapatinib tablet)

Experimental: Lapatinib 1500 mg + Letrozole 2.5 mg - Lapatinib (1500 mg once daily orally) with Letrozole (2.5 mg once daily orally)


Treatment: Drugs: Lapatinib
1500 mg orally once a day

Treatment: Drugs: Letrozole
2.5 mg orally once a day

Treatment: Drugs: Placebo
Placebo (which matched with lapatinib tablet)
Intervention code [1] 0 0
Treatment: Drugs
Comparator / control treatment
Control group

Outcomes
Primary outcome [1] 0 0
Number of Participants With Progression Free Survival (PFS) in the Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Advanced or Metastatic Breast Cancer as Assessed by the Investigator
Timepoint [1] 0 0
From the date of randomization until the date of the first documented progression or date of death from any cause, whichever came first, assessed for up to 46 months
Primary outcome [2] 0 0
Progression Free Survival (PFS) of Participants in the HER2-Positive Population as Assessed by the Investigator
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [1] 0 0
Number of Participants With PFS in the Intent-To-Treat (ITT) Population as Assessed by the Investigator
Timepoint [1] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [2] 0 0
PFS in Participants in the ITT Population as Assessed by the Investigator
Timepoint [2] 0 0
From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 46 months
Secondary outcome [3] 0 0
Overall Survival in the HER2-Positive Population
Timepoint [3] 0 0
From date of randomization until date of death due to any cause, assessed up to 46 months
Secondary outcome [4] 0 0
Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Timepoint [4] 0 0
Up to 46 months
Secondary outcome [5] 0 0
Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator
Timepoint [5] 0 0
Up to 46 months
Secondary outcome [6] 0 0
Clinical Benefit (CB) in the HER2-Positive Population as Assessed by the Investigator
Timepoint [6] 0 0
Up to 46 months
Secondary outcome [7] 0 0
Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the HER2-Positive Population as Assessed by the Investigator.
Timepoint [7] 0 0
Up to 46 months
Secondary outcome [8] 0 0
Number of Participants With the Indicated Best Response From the Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator.
Timepoint [8] 0 0
Up to 46 months
Secondary outcome [9] 0 0
Number of Participants With the Indicated Time to Response for CR or PR in the HER2-Positive Population as Assessed by the Investigator
Timepoint [9] 0 0
Up to 46 months
Secondary outcome [10] 0 0
Duration of Response for the Participants With CR or PR in the HER2-Positive Population as Assessed by the Investigator
Timepoint [10] 0 0
Up to 46 months
Secondary outcome [11] 0 0
Number of Participants With Evidence of Brain Metastases in the HER2-Positive Population
Timepoint [11] 0 0
Up to 46 months
Secondary outcome [12] 0 0
Time to Progression (TTP) for the HER2-Positive Population as Assessed by the Investigator
Timepoint [12] 0 0
Up to 46 months
Secondary outcome [13] 0 0
Overall Survival in the ITT Population
Timepoint [13] 0 0
From date of randomization until date of death due to any cause, assessed up to 46 months
Secondary outcome [14] 0 0
Overall Tumor Response (OR) for Participants With Measurable and Non-measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator
Timepoint [14] 0 0
Up to 46 months
Secondary outcome [15] 0 0
Number of Participants With Overall Tumor Response (OR) by Stratification Factors With Measurable Disease, Including Bone Scans, in the ITT Population as Assessed by the Investigator
Timepoint [15] 0 0
Up to 46 months
Secondary outcome [16] 0 0
Clinical Benefit (CB) in the ITT Population as Assessed by the Investigator
Timepoint [16] 0 0
Up to 46 months
Secondary outcome [17] 0 0
Number of Participants With the Indicated Time to Response for CR or PR in the ITT Population as Assessed by the Investigator
Timepoint [17] 0 0
Up to 46 months
Secondary outcome [18] 0 0
Duration of Response for the Participants With CR or PR in the ITT Population as Assessed by the Investigator
Timepoint [18] 0 0
Up to 46 months
Secondary outcome [19] 0 0
Number of Participants With Evidence of Brain Metastases From the ITT Population
Timepoint [19] 0 0
Up to 46 months
Secondary outcome [20] 0 0
TTP for Participants From the ITT Population as Assessed by the Investigator
Timepoint [20] 0 0
Up to 46 months
Secondary outcome [21] 0 0
Number of Participants Completing the Functional Assessment of Cancer Therapy-breast (FACT-B) Questionnaire at the Scheduled Visits
Timepoint [21] 0 0
Day 1 (baseline) visit; Week 12, 24, 36, 48, 60, 72, 84, 96, 108, 120, 132, 144, 156, 168, 180, and 192 visits; conclusion/withdrawal visit
Secondary outcome [22] 0 0
Adjusted Mean Change From Baseline for the FACT-B Total Score Using Observed Data
Timepoint [22] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [23] 0 0
Adjusted Mean Change From Baseline for the Functional Assessment of Cancer Therapy-General (FACT-G) Score Using Observed Data
Timepoint [23] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [24] 0 0
Adjusted Mean Change From Baseline for the Trial Outcome Index (TOI) Score Using Observed Data
Timepoint [24] 0 0
Week 12, 24, 36, and 48 visits; conclusion/withdrawal visit
Secondary outcome [25] 0 0
Number of Participants Classified as QOL Responders Based on the FACT-B, FACT-G, and TOI Total Scores
Timepoint [25] 0 0
Up to 46 months
Secondary outcome [26] 0 0
Number of Participants With Clinical Benefit Categorized by HER2 Fluorescence in Situ Hybridization (FISH) Status
Timepoint [26] 0 0
Up to 46 months
Secondary outcome [27] 0 0
Number of Participants With Clinical Benefit Categorized by HER2 ImmunoHistoChemistry (IHC) Intensity
Timepoint [27] 0 0
Up to 46 months
Secondary outcome [28] 0 0
Number of Participants With Response in Participants With Baseline Serum HER2 Extracellular Domain (ECD) Baseline Values Greater Than 15 Nanograms Per Milliliter (ng/mL) and 15 ng/mL or Lower
Timepoint [28] 0 0
Up to 46 months
Secondary outcome [29] 0 0
Number of HER2-Negative Participants at Baseline With and Without Seroconversion to a Status of HER2 Positive
Timepoint [29] 0 0
Up to 46 months
Secondary outcome [30] 0 0
Time to Seroconversion for Participants Who Were HER2 Negative at Baseline But Became HER2 Positive
Timepoint [30] 0 0
Up to 46 months
Secondary outcome [31] 0 0
Number of Participants With the Indicated Expression of Tumor by Epidermal Growth Factor Receptor (ErbB1/HER1/EGFR) at Baseline
Timepoint [31] 0 0
Baseline

Eligibility
Key inclusion criteria
Key inclusion criteria

1. Signed informed consent;
2. Subjects with histologically confirmed invasive breast cancer with stage IV disease at primary diagnosis or at relapse after curative-intent surgery;

* Subjects with either measurable or non-measurable disease per Response Evaluation Criteria in Solid Tumors (RECIST).
* If the disease was restricted to a solitary lesion, its neoplastic nature was confirmed by cytology or histology.
3. Tumors that were ER+ and/or PgR+;
4. Post-menopausal female subjects = 18 years of age.
5. ECOG Performance Status of 0 or 1;
6. Subjects who had archived tumor tissue available to compare tumor response with intra-tumoral expression of ErbB1 and ErbB2.
7. Adjuvant therapy with an aromatase inhibitor and / or trastuzumab was allowed; however, treatment was to stop more than 1 year prior (>12 months) to the first dose of randomized therapy.
8. Subjects must have ended hormonal replacement therapy (HRT) at least 1 month (30 days) prior to receiving the first dose of randomized therapy.

Key exclusion criteria:

1. Pre-menopausal, pregnant, or lactating;
2. Received prior chemotherapy, hormonal therapy, immunotherapy, biologic therapy, or anti-ErbB1/ErbB2 therapy for advanced or metastatic disease;
3. Bisphosphonate therapy for bone metastases was allowed; however, treatment was to be initiated prior to the first dose of randomized therapy. Prophylactic use of bisphosphonates in subjects without bone disease, except for the treatment of osteoporosis, was not permitted;
4. Used an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of randomized therapy (lapatinib or placebo);
5. Subjects with known history of/clinical evidence of CNS metastases or leptomeningeal carcinomatosis; and / or subjects on concurrent anti-cancer therapies other than letrozole; and / or who have not recovered from toxicities related to prior adjuvant therapy (surgery, radiotherapy, chemotherapy etc.)
6. Subjects with active or uncontrolled infection and/ or with history of uncontrolled or symptomatic angina, arrhythmias, or congestive heart failure.
Minimum age
18 Years
Maximum age
No limit
Sex
Females
Can healthy volunteers participate?
No
Key exclusion criteria

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?
The people receiving the treatment/s
The people administering the treatment/s
The people assessing the outcomes
The people analysing the results/data
Intervention assignment
Parallel
Other design features
Phase
Phase 3
Type of endpoint/s
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Data analysis
Reason for early stopping/withdrawal
Other reasons
Date of first participant enrolment
Anticipated
Actual
9/12/2003
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
22/03/2018
Sample size
Target
Accrual to date
Final
1286
Recruitment in Australia
Recruitment state(s)
ACT,QLD,SA
Recruitment hospital [1] 0 0
Novartis Investigative Site - Garran
Recruitment hospital [2] 0 0
Novartis Investigative Site - Douglas
Recruitment hospital [3] 0 0
Novartis Investigative Site - Herston
Recruitment hospital [4] 0 0
Novartis Investigative Site - Redcliffe
Recruitment hospital [5] 0 0
Novartis Investigative Site - Adelaide
Recruitment postcode(s) [1] 0 0
2606 - Garran
Recruitment postcode(s) [2] 0 0
4814 - Douglas
Recruitment postcode(s) [3] 0 0
4029 - Herston
Recruitment postcode(s) [4] 0 0
4020 - Redcliffe
Recruitment postcode(s) [5] 0 0
5000 - Adelaide
Recruitment outside Australia
Country [1] 0 0
United States of America
State/province [1] 0 0
Arizona
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United States of America
State/province [2] 0 0
Arkansas
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United States of America
State/province [3] 0 0
California
Country [4] 0 0
United States of America
State/province [4] 0 0
Colorado
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United States of America
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Connecticut
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Florida
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United States of America
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Georgia
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United States of America
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Illinois
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Indiana
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Iowa
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Kentucky
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Louisiana
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Massachusetts
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Minnesota
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Missouri
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Nebraska
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Nevada
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New Mexico
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New York
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North Carolina
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North Dakota
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Ohio
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Pennsylvania
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South Carolina
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Tennessee
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Texas
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Utah
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Vermont
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Virginia
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Washington
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United States of America
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West Virginia
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Argentina
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Buenos Aires
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Argentina
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Ciudad Autonoma de Buenos Aires
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Brazil
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Bahía
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Brazil
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Plovdiv
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Aalborg
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Roskilde
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Vejle
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Angers Cedex 01
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Besancon
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Grenoble Cedex 9
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Lille Cedex
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Montpellier
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Paris Cedex 5
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Pierre Benite Cedex
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Toulouse Cedex9
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Villejuif Cedex
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Baden-Wuerttemberg
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Bayern
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Germany
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Hessen
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Germany
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Niedersachsen
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Germany
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Nordrhein-Westfalen
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Rheinland-Pfalz
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Sachsen
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Schleswig-Holstein
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Thueringen
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Berlin
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Hamburg
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Kistarcsa
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Szeged
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Cork
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Galway
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Tallaght, Dublin
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Wilton, Cork
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Italy
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Emilia-Romagna
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Italy
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Lazio
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Italy
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Liguria
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Italy
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Lombardia
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Korea, Republic of
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Gyeonggi-do
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Korea, Republic of
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Seodaemun-gu, Seoul
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Korea, Republic of
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Seoul
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Doetinchem
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Eindhoven
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Heerlen
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Leidschendam
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Maastricht
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Nieuwegein
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Sittard-geleen
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Utrecht
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New Zealand
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Christchurch
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Pakistan
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Lahore
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Pakistan
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Rawalpindi
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Peru
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Callao
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Peru
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Lima
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Poland
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Bydogoszcz
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Krakow
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Poznan
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Warszawa
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Wroclaw
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Russian Federation
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Moscow
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Russian Federation
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St. Petersburg
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Capital Park
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Parktown
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Port Elizabeth
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Alcala De Henares (Madrid)
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Spain
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Badalona
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Spain
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Barcelona
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Spain
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Elche
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Spain
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Girona
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Spain
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Leganes, Madrid
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Spain
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Madrid
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Spain
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Malaga
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Spain
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Mostoles
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Spain
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Oviedo
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Spain
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Palma de Mallorca
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Spain
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San Sebastian
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Spain
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Valencia
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Spain
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Vigo ( Pontevedra)
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Spain
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Zaragoza
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Tunisia
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Sfax
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Tunisia
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Sousse
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Tunisia
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Tunis
Country [144] 0 0
Turkey
State/province [144] 0 0
Ankara
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Turkey
State/province [145] 0 0
Istanbul
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United Kingdom
State/province [146] 0 0
Essex
Country [147] 0 0
United Kingdom
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Lancashire
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United Kingdom
State/province [148] 0 0
Middlesex
Country [149] 0 0
United Kingdom
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Surrey
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United Kingdom
State/province [150] 0 0
West Midlands
Country [151] 0 0
United Kingdom
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Huddersfield
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United Kingdom
State/province [152] 0 0
London
Country [153] 0 0
United Kingdom
State/province [153] 0 0
Sheffield

Funding & Sponsors
Primary sponsor type
Commercial sector/industry
Name
Novartis Pharmaceuticals
Address
Country

Ethics approval
Ethics application status

Summary
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 and/or PgR positive) advanced or metastatic breast cancer, who had not received prior therapy for advanced or metastatic disease.
Trial website
https://clinicaltrials.gov/study/NCT00073528
Trial related presentations / publications
Johnston S, Pippen J Jr, Pivot X, Lichinitser M, Sadeghi S, Dieras V, Gomez HL, Romieu G, Manikhas A, Kennedy MJ, Press MF, Maltzman J, Florance A, O'Rourke L, Oliva C, Stein S, Pegram M. Lapatinib combined with letrozole versus letrozole and placebo as first-line therapy for postmenopausal hormone receptor-positive metastatic breast cancer. J Clin Oncol. 2009 Nov 20;27(33):5538-46. doi: 10.1200/JCO.2009.23.3734. Epub 2009 Sep 28.
Schwartzberg LS, Franco SX, Florance A, O'Rourke L, Maltzman J, Johnston S. Lapatinib plus letrozole as first-line therapy for HER-2+ hormone receptor-positive metastatic breast cancer. Oncologist. 2010;15(2):122-9. doi: 10.1634/theoncologist.2009-0240. Epub 2010 Feb 15. Erratum In: Oncologist. 2010;15(3):327. Schwarzberg, Lee S [corrected to Schwartzberg, Lee S].
Sherrill B, Amonkar MM, Sherif B, Maltzman J, O'Rourke L, Johnston S. Quality of life in hormone receptor-positive HER-2+ metastatic breast cancer patients during treatment with letrozole alone or in combination with lapatinib. Oncologist. 2010;15(9):944-53. doi: 10.1634/theoncologist.2010-0012. Epub 2010 Aug 26.
Finn RS, Press MF, Dering J, O'Rourke L, Florance A, Ellis C, Martin AM, Johnston S. Quantitative ER and PgR assessment as predictors of benefit from lapatinib in postmenopausal women with hormone receptor-positive, HER2-negative metastatic breast cancer. Clin Cancer Res. 2014 Feb 1;20(3):736-43. doi: 10.1158/1078-0432.CCR-13-1260. Epub 2013 Nov 6.
Prat A, Cheang MC, Galvan P, Nuciforo P, Pare L, Adamo B, Munoz M, Viladot M, Press MF, Gagnon R, Ellis C, Johnston S. Prognostic Value of Intrinsic Subtypes in Hormone Receptor-Positive Metastatic Breast Cancer Treated With Letrozole With or Without Lapatinib. JAMA Oncol. 2016 Oct 1;2(10):1287-1294. doi: 10.1001/jamaoncol.2016.0922.
Wedam SB, Beaver JA, Amiri-Kordestani L, Bloomquist E, Tang S, Goldberg KB, Sridhara R, Ibrahim A, Kim G, Kluetz P, McKee A, Pazdur R. US Food and Drug Administration Pooled Analysis to Assess the Impact of Bone-Only Metastatic Breast Cancer on Clinical Trial Outcomes and Radiographic Assessments. J Clin Oncol. 2018 Apr 20;36(12):1225-1231. doi: 10.1200/JCO.2017.74.6917. Epub 2018 Mar 9.
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Novartis Pharmaceuticals
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Novartis Pharmaceuticals
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Summary Results

For IPD and results data, please see https://clinicaltrials.gov/study/NCT00073528