Phase 2
Completed N=92
Letrozole In Combination With Lapatinib In Neoadjuvant Treatment Of Early Breast Cancer
Source: ClinicalTrials.gov NCT00422903 ↗Enrolled (actual)
92
Serious AEs
4.4%
Results posted
Aug 2012
Primary outcomePrimary: Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee — 2; 12; 58; 54 percentage of participants
Summary
Evaluate the percentage of clinical objective responses (cOR) in patients with HER2 negative early breast cancer treated with pre operative (neoadjuvant)lapatinib and letrozole
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Participants With Clinical Objective Response (cOR) in the Breast, Evaluated by an Independent Radiological Evaluation Monitoring Committee |
2; 12; 58; 54 | — |
| PRIMARY Percentage of Participants With Various Responses in the Breast, Evaluated Using Per Protocol Criteria |
2; 12; 27; 34; 40; 24 | — |
| SECONDARY Percentage of Participants With Pathological Complete Response (pCR) in the Breast and Axillary Nodes, Evaluated Using Miller and Payne Criteria |
0; 0 | — |
| SECONDARY Number of Participants With Breast Tumors Per Pathological Stage at Surgery |
1; 0; 20; 26; 24; 12 | — |
| SECONDARY Number of Participants With the Indicated Nodal Status at Surgery |
19; 21; 28; 21 | — |
| SECONDARY Number of Participants With the Indicated Type of Surgery |
13; 15; 34; 27; 2; 1 | — |
| SECONDARY Percentage of Participants With Conversion From Planned Mastectomy at Baseline to BCS at Surgery |
56; 46 | — |
| SECONDARY Number of Participants With the Indicated Adverse Events With a Classification of >=Grade 2 |
4; 2; 2; 10; 0; 8 | — |
| SECONDARY Mean Left Ventricular Ejection Fraction (LVEF) |
61; 61; 62; 60; 61; 59 | — |
| SECONDARY Time to Treatment Failure From the Start of the Primary Therapy |
32.2; 22.2 | — |
Eligibility 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 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)
Data sourced from ClinicalTrials.gov (NCT00422903). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.