mamma carcinoma MedDRA version: 20.0 Level: SOC Classification code 10029104 Term: Neoplasms benign, malignant and unspecified (incl cysts and polyps) System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Interventions
Trade Name: Lonsurf®
Product Name: S95005
Product Code: S95005
Pharmaceutical Form: Film-coated tablet
Sponsors
BOOG Study Center
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Adult women (= 18 years of age) with proven diagnosis of metastatic or locally advanced breast cancer not amenable to curative treatment by surgery or radiotherapy 2. Documented ER positive (.10%)/ PR positive (.10%) and HER2 negative metastatic breast cancer 3. Progressive disease based on imaging 4. Women previously treated with systemic treatment includingan anthracycline, a taxane and capecitabine either in the (neo)adjuvant or metastatic setting. N.B. A patient with a cardiac reason to preclude an anthracycline as well as a patient with a known/documented DPD-deficiency may be included 5. Evaluable disease as defined per RECIST v.1.1 (see Appendix E). Tumor lesions previously irradiated or subjected to other locoregional therapy will only be deemed measurable if disease progression at the treated site after completion of therapy is clearly documented. 6. Eastern Cooperative Oncology Group (ECOG) performance status= 1 7. Life expectancy of = 12 weeks 8. Willing and able to comply with scheduled visits and study procedures 9. Adequate organ, bone marrow and coagulation function as shown by: • Absolute neutrophil count (ANC) = 1.5 ×109/L • Platelets = 75 ×109/L • Hemoglobin (Hgb) = 5.6 mmol/L • Serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) = 2.5 ULN (or = 5 if hepatic metastases are present) • Total serum bilirubin = 1.5 × ULN (= 3 × ULN for patients known to have Gilbert Syndrome) • Creatinine clearance =60 ml/min 10. Written informed consent obtained before any screening procedure and according to local guidelines. 11. Resolution of all acute toxic effects of prior anti-cancer therapy or surgical procedures to NCI CTCAE version 4.0 Grade =1, except alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 40 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 10
Exclusion criteria
Exclusion criteria: 1. HER2-overexpressing patients by local laboratory testing (IHC 3+ staining or in situ hybridization positive) and ER-negative patients are not eligible 2. No more than two lines of chemotherapy for advanced disease 3. Resolution of side-effects from previous chemotherapy = grade 1 (except for alopecia) 4. Radiotherapy within four weeks prior to enrollment is not allowed except in case of localized radiotherapy for analgesic purpose or for lytic lesions at risk of fracture which can then be completed within two weeks prior to enrollment. Patients must have recovered from radiotherapy toxicities prior to enrollment. 5. 30% or more marrow-bearing bone being irradiated. Other primary tumors within the last 5 years before study entry are not allowed, except for adequately controlled basal cell carcinoma of the skin, or carcinoma in situ of the cervix. 6. Previous or current CNS metastases, carcinomatous meningitis, are not allowed. A CT or MRI of the brain must be performed within 4 weeks prior to randomization if the presence of metastases at this site is suspected. 7. Evidence of clinically significant cardiovascular or pulmonary disease or any other disease, metabolic or psychological dysfunction, physical examination finding, or clinical laboratory finding giving reasonable suspicion of a disease or condition that contraindicates the use of an investigational drug, or that may affect patient compliance with study routines, or places the patient at high risk from treatment related complications. (e.g. lactose intolerance) 8. Previously received trifluridine/tipiracil 9. Since trifluridine/tipiracil contains lactose, patients with rare hereditary problems of galactose intolerance, the Lapp lactase deficiency or glucose-galactose malabsorption should not take this medicine (see section 4.4 of the SmPC). (Appendix A) 10. Diagnosis of any other malignancy prior to randomization, except those that are not believed to influence the patient’s prognosis and do not require any further treatment. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study. 11. Other severe acute or chronic medical or psychiatric condition or laboratory abnormality that may increase the risk associated with study participation or investigational product administration or may interfere with the interpretation of study results and, in the judgment of the investigator, would make the patient inappropriate for entry into this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: To evaluate the efficacy of trifluridine/tipiracil by determination of the percentage of patients being progression free at 8 weeks on trifluridine/tipiracil prescribed for ER-positive, HER2-negative advanced breast cancer patients previously treated with an anthracycline, a taxane and capecitabine;Secondary Objective: • Progression-free survival • Response rate CR/PR at 16 weeks • Adverse events • QoL ;Primary end point(s): progression free at 8 weeks ;Timepoint(s) of evaluation of this end point: 8 weeks after end of treatment | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): • Progression-free survival • Response rate CR/PR at 16 weeks • Adverse events • QoL ;Timepoint(s) of evaluation of this end point: progression free = 8 weeks after end of treatment; response rate CR/RT at 16 weeks; QoL at 8, 16, 24 and 32 weeks; Safety evaluation 30 days after end of treatment | — |
Countries
Netherlands
Contacts
Public ContactM.E.M.M. Bos
Erasmus MC
Outcome results
None listed