None listed
Conditions
Interventions
GROUP 1 Type of group
This group will be treated with Lapatinib, in a dose of 1500 mg (6 tablets), PO, QD, for a maximum of 1 year, until recurrence of the disease occurs, unacceptable toxicity or the patient decides to withdraw from the study.
Group name:GROUP 2 Type of group
This group will be treated with Lapatinib Placebo (6 tablets), PO, QD, for a maximum of 1 year, until recurrence of the disease occurs, unacceptable toxicity or the patient decides to withdraw from the study.
Sponsors
GLAXOSMITHKLINE PERU S.A.,
Eligibility
Inclusion criteria
Inclusion criteria: 1. Have invasive breast carcinoma (Tx or T1.4) histologically or cytologically confirmed with ErbB2 overexpression at the time of initial diagnosis and having undergone an adequate excision of the tumor. 2. Having had tumors with ErbB2 overexpression defined as either: a) 3+ by IHC. OR b) Amplification of c-erbB2 gene by FISH. OR c) 0, 1+, 2+ by IHC and amplification of c-erbB2 gene by FISH. 3. Using the staging criteria for breast cancer of the American Joint Committee on Cancer (6th edition) a woman should have a disease between Stage I and Stage IIIb. 4. Women with synchronous bilateral invasive breast cancer or synchronous DCIS of the breast either ipsilateral or contralateral at the time of initial diagnosis are also eligible. 5. Have completed all primary adjuvant chemotherapy regimens prior to enrolling in the study. 6. Women who have not received trastuzumab in the adjuvant setting, if the doctor or patient has considered that treatment and decided not to start therapy with trastuzumab for practical reasons. 7. Have clinical or radiological evaluations that are negative for local or regional recurrence. 8. Patient must have had an ER and progesterone receptor (PgR) test on the primary tumor before entering the study. 9. Having passed either total mastectomy or lumpectomy. 10. Must have received a previous adjuvant chemotherapy regimen containing either an anthracycline or a taxane; or any regimen of cyclophosphamide, metrotexate and 5-fluorouracil. 11. Patient could continue receiving endocrine therapy. 12. Patient may have received prior radiation therapy as treatment for the primary tumor. 13. Patient may continue to receive radiation therapy while taking the study medication. 14. Patient may continue to receive bisphosphonates only for documented osteoporosis treatment. 15. Not having received prior therapy with an ErbB 1 and / or ErbB2 inhibitor. 16. Have a cardiac ejection fraction within the normal range. 17. Have a Performance Status of the Western Group of Cooperative Oncology (ECOG) from 0 to 1. 18. Women with a history of non-breast neoplasms are eligible if they have been disease-free for at least 5 years. 19. Be able to swallow and retain oral medication. 20. Have archived tumor samples available for biomarker analysis. 21. Be able to complete all screening evaluations. 22. Have an adequate organic function. 23. Have signed the informed consent form (ICF). 24. Having ≥18 years of age with any menopausal state: A) Without the potential to have children. B) With the potential to have children. These subjects must have a negative pregnancy test at the moment of screening and being in agreement with one of the following: a) Complete abstinence or b) Constant and correct use of one of the acceptable methods of birth control.
Exclusion criteria
Exclusion criteria: 1. Have clinical and radiological evidence of local or regional recurrence. 2. Having had metachronous invasive breast cancer. 3. Have a previous history of other malignant neoplasms of the breast. 4. Being unable to provide an archived sample of tumor tissue for analyzes. 5. Having had prior therapy with an ErbB 1 and / or ErbB2 inhibitor. 6. Receive concurrent anticancer therapy while taking the study medication. 7. Have serious, unresolved or unstable toxicity from a previous administration of another research product and / or previous treatment for cancer. 8. Have malabsorption syndrome, a disease that significantly affects gastrointestinal function, or resection of the stomach or small intestine. Women with ulcerative colitis are also excluded. 9. Have an active or uncontrolled infection. 10. Have dementia, altered mental status or any psychiatric condition that could prohibit the understanding or delivery of informed consent. 11. Have a known history of uncontrolled or symptomatic angina, arrhythmias, or CHF. 12. Being pregnant or breastfeeding. 13. Receive concurrent treatment with an investigational agent or participate in another clinical trial. 14. Receive concurrent treatment with prohibited medications. 15. Have used a research drug within 30 days or 5 half-lives, whichever is longer, before the first dose of study medication. 16. Have an immediate or delayed known reaction of hypersensitivity or idiosyncrasy to drugs chemically related to lapatinib or to excipients. 17. In France, subjects who are not affiliated with a charity or social security category.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to determine the recurrence of the disease, which may be: Local after the mastectomy, local in the ipsilateral breast after the lumpectomy, regional, distant, contralateral breast cancer, including ductal carcinoma in situ (DCIS), other second primary cancer OR Death from any cause without previous event. Measure:Disease free survival (DFS). Timepoints:After one year of treatment and after 5 years of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Outcome name:Clinical evaluation to determine the recurrence of the disease, which may be: Local after the mastectomy, local in the ipsilateral breast after the lumpectomy, regional, distant, contralateral breast cancer, including ductal carcinoma in situ (DCIS), other second primary cancer OR Death from any cause without previous event. Any recurrence should be demonstrated with images (CT, MRI) and / or cytological / histological tests. The quality of life will be determined by means of a general health status questionnaire, the Short Format of 36 Items of the Medical Results Study (Version 2). Measure:Secondary efficacy: 1) Recurrence-free survival. 2) Free survival of distant recurrence. 3) General survival. 4) Survival free of recurrence to the CNS. 5) Recurrence rate to the CNS. 6) Quality of Life related to health. Timepoints:Survival measures and recurrence rates: At one year of treatment and at 5 years of follow-up. Quality of Life: At the beginning of the study, in the 6th and 12th months of the treatment and every 6 months after the discontinuation up to 24 months. ; Outcome name:1) Adverse events: Their severity, relationship with the study medication, the action taken and previous experiences will be evaluated. 2) Laboratory tests: Panels of serum chemistry and hematology, urinalysis. 3) Incidence of cardiac dysfunction: Where cardiac dysfunction will be defined as left cardiac ventricular dysfunction or changes in the QT / QTc interval. Measure:Safety of treatment: 1) Adverse events. 2) Laboratory tests. 3) Incidence of cardiac dysfunction. Timepoints:From the beginning of the treatment and every 12 months. ; Outcome name:Somatic mutations should be determined: mutations, deletions, amplifications in genes such as ErbBl, ErbB2, phosphatase homolog and tensine (PTEN), etc. in the pre-treatment biopsy. Likewise, in these same specimens the presence of tumor biomarkers must be determined: ErbBl, ErbB2, ins | — |
Countries
Argentina, Australia, Belgium, Brazil, Canada, Chile, China, Croatia, Czech Republic, Denmark, France, Germany, Greece, Hungary, India, Israel, Italy, Korea North, Latovia, Lithuania, Mexico, New Zealand, Philippines, Poland, Russian Federation, Slovakia, South Africa, Spain, Ukraine, United Kindgdom, United States
Outcome results
None listed