None listed
Conditions
Interventions
None listed
Sponsors
F. HOFFMANN-LA ROCHE LTD.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. SIGNED INFORMED CONSENT FORM(S) FOR THIS STUDY 2. COMPLETED SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT ON THE PARENT STUDY OR WHO CONTINUE TO RECEIVE SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT AT THE TIME OF THE PARENT STUDY CLOSURE AND RECEIVED THE LAST STUDY-DRUG DOSE WITHIN THE 6 WEEKS PRIOR TO THE FIRST SCHEDULED DOSE OF STUDY THERAPY ON THE EXTENSION STUDY. 3. EXPECTATION BY THE INVESTIGATOR THAT THE PATIENT MAY CONTINUE TO BENEFIT FROM ADDITIONAL SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT. 4. LVEF = 40% BASELINE WITHIN 30 DAYS PRIOR TO STUDY ENTRY AS DETERMINED BY EITHER ECHO OR MUGA. PATIENTS WITH AN LVEF = 40%-45% MUST HAVE HAD AN ABSOLUTE CHANGE OF <10% FROM BASELINE (USING AS REFERENCE THE BASELINE LVEF FROM THE PARENT STUDY PRIOR TO THE START OF T-DM1 THERAPY). SEE APPENDIX F FOR INSTRUCTIONS IN THE EVENT THAT THE UNAVAILABILITY OF TECHNETIUM-99 (TC-99M) PRECLUDES THE USE OF BONE SCANS OR MUGA SCANS.
Exclusion criteria
Exclusion criteria: 1. ADVERSE EVENT(S) LEADING TO SINGLE-AGENT T-DM1 OR COMBINATION T-DM1 TREATMENT DISCONTINUATION IN THE PARENT STUDY. 2. ONGOING SERIOUS ADVERSE EVENT(S) FROM THE PARENT STUDY. 3. PROGRESSIVE DISEASE (EXCEPT FOR ISOLATED BRAIN METASTASES UNDER CERTAIN CONDITIONS AS DESCRIBED IN SECTION 3.1) ON SINGLE-AGENT T-DM1 OR A T-DM1-CONTAINING REGIMEN DURING PARENT STUDY OR BEFORE STARTING THE EXTENSION STUDY, WITH THE EXCEPTION OF PATIENTS FROM STUDY TDM4688G WITH EARLY PROGRESSIVE DISEASE WHO WENT ON TO RECEIVE PERTUZUMAB + T-DM1 TREATMENT AND HAVE NOT EXPERIENCED FURTHER DISEASE PROGRESSION ON THE COMBINATION REGIMEN. COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI) SCAN OF THE CHEST, ABDOMEN AND PELVIS IS MANDATORY WITHIN 30 DAYS PRIOR TO STUDY ENTRY. CT OR MRI SCAN OF THE BRAIN IS MANDATORY (WITHIN 30 DAYS PRIOR TO STUDY ENTRY) IN CASES OF CLINICAL SUSPICION OF BRAIN METASTASES. 4. PERIPHERAL NEUROPATHY OF GRADE = 3 PER NATIONAL CANCER INSTITUTE COMMON TERMINOLOGY CRITERIA FOR ADVERSE EVENTS (NCI CTCAE), VERSION 3.0.
Countries
Peru
Outcome results
None listed