Last updated: 11/04/2018 06:29:40
This product has been transferred to Novartis. GSK Clinical Study Register is no longer maintained for this study. The most up to date information is available on clinicaltrials.gov.
Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer
EudraCT ID
EU CT Number
Not applicable
Trial status
No longer a GSK study
No longer a GSK study
Trial overview
Official title: Letrozole versus Letrozole plus Lapatinib (GW572016) in hormone-sensitive, HER-2 negative operable breast cancer. A double blind randomized Phase II study with biomarker evaluation.
Trial description: Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole
Primary purpose:
Treatment
Trial design:
Parallel Assignment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Allocation:
Randomized
Primary outcomes:
Percentage of participants with clinical objective response (cOR) in the breast, evaluated by an Independent Radiological Evaluation Monitoring Committee
Timeframe: From Baseline (Day 1) up to 6 months, evaluated every 12 weeks
Percentage of participants with various responses in the breast, evaluated using Per Protocol Criteria
Timeframe: From Baseline (Day 1) up to 6 months, evaluated every 12 weeks
Secondary outcomes:
Percentage of participants with pathological complete response (pCR) in the breast and axillary nodes, evaluated using Miller and Payne criteria
Timeframe: At the point of definitive surgery (up to 6 months after Baseline)
Number of participants with breast tumors per pathological stage at surgery
Timeframe: At the point of definitive surgery (up to 6 months after Baseline)
Number of participants with the indicated nodal status at surgery
Timeframe: At the point of definitive surgery (up to 6 months after Baseline)
Number of participants with the indicated type of surgery
Timeframe: At the point of definitive surgery (up to 6 months after Baseline 1)
Percentage of participants with conversion from planned mastectomy at baseline to BCS at surgery
Timeframe: At the point of definitive surgery (up to 6 months after Baseline)
Number of participants with the indicated adverse events with a classification of >=Grade 2
Timeframe: From Baseline (Day 1) up to 6 months (until definitive surgery)
Mean left ventricular ejection fraction (LVEF)
Timeframe: Baseline (Day 1), after 12 weeks, and after 24 weeks
Time to treatment failure from the start of the primary therapy
Timeframe: From Baseline (Day 1) up to study withdrawal (approx. 66 months)
Interventions:
Drug: lapatinib
Drug: letrozole
Other: placebo
Enrollment:
92
Observational study model:
Not applicable
Primary completion date:
2012-30-06
Time perspective:
Not applicable
Clinical publications:
Not applicable
Medical condition
Neoplasms, Breast
Product
lapatinib
Collaborators
Not applicable
Study date(s)
April 2007 to June 2012
Type
Interventional
Phase
2
Participation criteria
Sex
Female
Age
18 - 80 years
Accepts healthy volunteers
No
- Histologically confirmed infiltrating primary breast cancer of 2.0 cm or more in largest clinical diameter
- ER and/or PgR positive cancer (> 10% of positive cancer cell assessed by IHC)
- Stage IIIB, IIIC, and inflammatory breast cancer
- Stage IV breast cancer
Inclusion and exclusion criteria
Inclusion criteria:
- Histologically confirmed infiltrating primary breast cancer of 2.0 cm or more in largest clinical diameter
- ER and/or PgR positive cancer (> 10% of positive cancer cell assessed by IHC)
- Postmenopausal status, defined by at least one of the following: ≥ 60 years of age < 60 years of age and amenorrheic for ≥ 12 months prior to day 1 < 60 years of age and amenorrheic for < 12 months prior to day, or without a uterus: luteinizing hormone (LH) and follicle stimulating hormone (FSH) values within postmenopausal range Prior bilateral oophorectomy Prior radiation castration with amenorrhea for at least 6 months
- HER2 negative tumors (IHC 0-2+, or FISH negative)
- Availability of tumor tissue suitable for biological and molecular examination before starting primary treatment
- Age over 18 years
- ECOG PS 0-1
- Normal organ and marrow function as defined below: leukocytes > 3000/mL absolute neutrophil count > 1,500/mL platelets > 100,000/mL total bilirubin within normal institutional limits AST (SGOT)/ALT(SGPT)< 2.5 X institutional upper limit of normal Creatinine within normal institutional limits
- Cardiac ejection fraction within the institutional range of normal as measured by echocardiogram or MUGA scan.
- Eligibility of patients receiving medications or substances known to affect, or with the potential to affect the activity or pharmacokinetics of lapatinib will be determined following review of their use by the Principal Investigator. A list of medications and substances known or with the potential to interact with CYP450 isoenzymes is provided
- Ability to understand and the willingness to sign a written informed consent document.
- Ability to swallow and retain oral medication.
Exclusion criteria:
- Stage IIIB, IIIC, and inflammatory breast cancer
- Stage IV breast cancer
- Contraindication to the treatment with letrozole
- Prior treatment with chemotherapy, endocrine therapy or radiotherapy. Prior treatment with EGFR targeting therapies
- Treatment with any other investigational agents, or with all herbal (alternative) medicines
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to lapatinib
- Uncontrolled inter-current illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- HIV-positive patients receiving combination anti-retroviral therapy
- GI tract disease resulting in an inability to take oral medication, malabsorption syndrome, a requirement for IV alimentation, prior surgical procedures affecting absorption, uncontrolled inflammatory GI disease (e.g., Crohn's, ulcerative colitis)
- Concomitant requirement for medication classified as CYP3A4 inducers or inhibitors (See section 3.7.4.2 Other concomitant treatments)
Trial location(s)
Location
GSK Investigational Site
Treviglio (BG), Lombardia, Italy, 24047
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Carpi (MO), Emilia-Romagna, Italy, 41012
Status
Study Complete
Location
GSK Investigational Site
Forlì, Emilia-Romagna, Italy, 47100
Status
Terminated/Withdrawn
Location
GSK Investigational Site
Piacenza, Emilia-Romagna, Italy, 29100
Status
Study Complete
Study documents
Scientific result summary
Available language(s): English
If you wish to request for full study report, please contact - [email protected]
Results overview
Results posted on ClinicalTrials.gov
Recruitment status
No longer a GSK study
Actual primary completion date
2012-30-06
Actual study completion date
2012-30-06
Plain language summaries
Plain language summaries of clinical trial results for Phase 2-4 clinical trials that were initiated on or after January 2022 will be posted by GSK within one year following study completion.
Additional information about the trial
Additional information
Not applicable
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