Note: Sample collection in China will comply with local regulatory approval.
Immunotherapy (non-antibody-based therapy): ≥ 2 weeks or 5 times the terminal elimination T½ of the agent, whichever is longer.
#Dato meaning sex Activator#
Antibody-based anticancer therapy: ≥ 4 weeks with the exception of receptor activator of nuclear factor kappa-B ligand (RANKL) inhibitors (eg, denosumab for the treatment of bone metastases).Anticancer therapy including hormonal therapy: ≥ 3 weeks (for small molecule targeted agents: ≥ 2 weeks or 5 half-lives, whichever is longer).Radiation therapy including palliative radiation to chest: ≥ 4 weeks (palliative radiation therapy to other areas ≥ 2 weeks).Has had an adequate treatment washout period before Cycle 1 Day 1, defined as: LVEF ≥ 50% by either an echocardiogram or MUGA within 28 days of first dosing.Calculated creatinine clearance: ≥ 30 mL/min as calculated using the Cockcroft-Gault equation (using actual body weight).ALT and AST: ≤ 3 × ULN for AST/ALT however, if elevation is due to liver metastases, ≤ 5.0 × ULN is allowed.Total bilirubin: ≤ 1.5 × ULN if no liver metastases or ≤ 3 × ULN in the presence of documented Gilbert's syndrome (unconjugated hyperbilirubinemia) or liver metastases at baseline.A minimum of 2 weeks must have elapsed between the end of radiotherapy and study enrolment.Īdequate organ and bone marrow function within 7 days before day of first dosing as follows: Participants with a history of previously treated neoplastic spinal cord compression, or clinically inactive brain metastases, who require no treatment with corticosteroids or anticonvulsants, may be included in the study, if they have recovered from the acute toxic effect of radiotherapy.Note: Participants with bone-only metastases are not permitted. At least 1 measurable lesion not previously irradiated that qualifies as a RECIST 1.1.ECOG PS of 0 or 1, with no deterioration over the previous 2 weeks prior to day of first dosing.Eligible for one of the chemotherapy options listed as ICC (eribulin, capecitabine, vinorelbine, gemcitabine), per investigator assessment.Participant must have documented progression on their most recent line of chemotherapy. Progressed on and not suitable for endocrine therapy per investigator assessment and treated with 1 to 2 lines of prior chemotherapy in the inoperable/metastatic setting.Inoperable or metastatic HR+, HER2-negative breast cancer.Type of Participant and Disease Characteristics Participant must be ≥ 18 years at the time of screening.Why Should I Register and Submit Results?.
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