None listed
Conditions
Interventions
PATIENTS WITH HER2-POSITIVE ADVANCED BREAST CANCER (METASTATIC OR LOCALLY RECURRENT) WHO HAVE NOT PREVIOUSLY RECEIVED SYSTEMIC NON-HORMONAL ANTICANCER THERAPY IN THE METASTATIC SETTING ARE ELIGIBLE TO
Sponsors
F. HOFFMANN-LA ROCHE LTD.,
Eligibility
Age
18 Years to 90 Years
Inclusion criteria
Inclusion criteria: 1. SIGNED WRITTEN INFORMED CONSENT APPROVED BY THE RELEVANT INSTITUTIONAL REVIEW BOARD (1RB), OR INDEPENDENT ETHICS COMMITTEE (1EC). 2. MALE OR FEMALE PATIENTS AGED 18 YEARS OR OVER. 3. HISTOLOGICALLY OR CYTOLOGICALLY CONFIRMED AND DOCUMENTED ADENOCARCINOMA OF THE BREAST WITH METASTATIC OR LOCALLY RECURRENT DISEASE NOT AMENABLE TO CURATIVE RESECTION. 4. HER2-POSITIVE (DEFINED AS EITHER IHC 3+ OR IN SITU HYBRIDIZATION [ISH] POSITIVE) AS ASSESSED BY LOCAL LABORATORY ON PRIMARY TUMOR AND/OR METASTATIC SITE IF PRIMARY TUMOR NOT AVAILABLE (ISH POSITIVITY IS DEFINED AS A RATIO OF 2.0 OR GREATER FOR THE NUMBER OF HER2 GENE COPIES TO THE NUMBER OF SIGNALS FOR CEP17, OR FOR SINGLE PROBE TESTS, A HER2 GENE COUNT GREATER THAN 4). 5. AT LEAST ONE MEASURABLE LESION AND/OR NON-MEASURABLE DISEASE EVALUABLE ACCORDING TO RESPONSE EVALUATION CRITERIA IN SOLID TUMORS (RECIST) VERSION 1.1. (APPENDIX 5). 6. EASTERN COOPERATIVE ONCOLOGY GROUP (ECOG) PERFORMANCE STATUS 0, 1 OR 2 (APPENDIX 3). 7. LVEF OF AT LEAST 50%. 8. NEGATIVE SERUM PREGNANCY TEST IN WOMEN OF CHILDBEARING POTENTIAL (WOCBP; PREMENOPAUSAL OR LESS THAN 12 MONTHS OF AMENORRHEA POST-MENOPAUSE, AND WHO HAVE NOT UNDERGONE SURGICAL STERILIZATION).
Exclusion criteria
Exclusion criteria: • 1. PREVIOUS SYSTEMIC NON-HORMONAL ANTICANCER THERAPY FOR THE METASTATIC OR LOCALLY RECURRENT DISEASE. 2. DISEASE-FREE INTERVAL FROM COMPLETION OF ADJUVANT OR NEOADJUVANT SYSTEMIC NON-HORMONAL TREATMENT TO RECURRENCE WITHIN 6 MONTHS. 3. PREVIOUS APPROVED OR INVESTIGATIVE ANTI-HER2 AGENTS IN ANY BREAST CANCER TREATMENT SETTING, EXCEPT TRASTUZUMAB AND/OR LAPATINIB IN THE ADJUVANT OR NEOADJUVANT SETTING. 4. DISEASE PROGRESSION WHILE RECEIVING TRASTUZUMAB AND/OR LAPATINIB IN THE ADJUVANT OR NEOADJUVANT SETTING. 5. HISTORY OF PERSISTENT GRADE 2 OR HIGHER (NATIONAL CANCER INSTITUTE [NCI]-COMMON TOXICITY CRITERIA [CTC], VERSION 4.0) HEMATOLOGICAL TOXICITY RESULTING FROM PREVIOUS ADJUVANT OR NEOADJUVANT THERAPY. 6. RADIOGRAPHIC EVIDENCE OF CENTRAL NERVOUS SYSTEM (CNS) METASTASES AS ASSESSED BY COMPUTED TOMOGRAPHY (CT) OR MAGNETIC RESONANCE IMAGING (MRI). 7. CURRENT PERIPHERAL NEUROPATHY OF GRADE 3 OR GREATER (NCI-CTC, VERSION 4.0). 8. HISTORY OF OTHER MALIGNANCY WITHIN THE LAST 5 YEARS PRIOR TO 1ST STUDY DRUG ADMINISTRATION (DOSING), EXCEPT FOR CARCINOMA IN SITU OF THE CERVIX OR BASAL CELL CARCINOMA.
Countries
Arabia Saudi, Argentina, Australia, Austria, Belgium, Brazil, Canada, China, Colombia, Ecuador, Egypt, Estonia, Finland, France, Germany, Greece, Hungary, India, Israel, Italy, Lebano, Lithuania, Mexico, Morocco, Netherlands, Pakistan, Portugal, Slovenia, Spain, Sweden, Turkey, United Arab Emirates, United Kindgdom, Uruguay, Venezuela
Contacts
Public ContactHedwig Schmidt
ROCHE FARMA (PERU) S.A.
Outcome results
None listed