Testing Sacituzumab Govitecan (SG) for advanced triple negative breast cancer

Inclusion

• +Eastern Cooperative Oncology Group (ECOG) performance status 0-1.
• +Controlled brain metastasis (as per clinical determination) is allowed in the study at least 4 weeks before treatment. Controlled brain metastasis is defined as asymptomatic brain metastasis or no longer requiring high doses of corticosteroids (\>10 mg Dexamethasone per day) for central nervous system (CNS) symptom management. Anticonvulsants and stable corticosteroids dose can be included in the study.
• +Participants must meet all the following criteria to be eligible for participation in this study:
• +Willing and able to provide informed consentInformed consentThe process of being told what taking part involves, then choosing freely.Read more →.
• +Age \>18 years old at the time of informed consent and has signed informed consent before any trial related activities are conducted according to local guidelines.
• +For participants considered not of child-bearing potential (postmenopausal): must meet one of the following criteria at the time of study entry:
• +Histologically and/or cytologically confirmed diagnosis of estrogen-receptor negative breast cancer by local laboratory testing (based on most recently analyzed biopsy).
• +HER2-negative breast cancer (based on most recently analyzed biopsy) defined as negative in situ hybridization test or an immunohistochemistry (IHC) status of 0, 1+ or 2+. If IHC is 2+, a negative in situ hybridization (FISH, CISH, SISH) test is required by local laboratory testing, as defined in the relevant American Society of Clinical Oncology / College of American Pathologists Guidelines.
• +Not previously received systemic therapy in the advanced setting.
• +Life expectancy \> 3 months.
• +Acceptable bone marrow and organ function defined by the following laboratory values without transfusion or growth factor support within 2 weeks of treatment initiation:
• +a. Absolute neutrophil count \> 1.0 x 109/L i. Platelets \> 100 x 109/L ii. Hemoglobin \> 90 g/dL iii. Potassium, sodium, calcium (corrected for serum albumin), and magnesium within normal limits.
• +iv. INR \< 1.5 v. Serum creatinine \<1.5 x upper limit of normal (ULN) or calculated (Cockroft-Gault) or measured creatinine clearance ≥50 mL/min/1.73 m2 b. In absence of liver metastases, ALT and AST should be below \<3.0 x ULN. If the participant has liver metastases, ALT and AST should be \< 5.0 x ULN.
• +c. In absence of liver metastases, total serum bilirubin \< ULN; If the participant has liver metastases, total bilirubin \< 3.0 x ULN with direct bilirubin \< 1.5 x ULN.
• +Consents to allow access and provision of pre- and post-treatment biopsy specimens for study purposes.
• +Able to communicate with the InvestigatorPrincipal investigatorThe doctor or researcher responsible for running the study at a site.Read more → and comply with the requirements of the study procedures.
• +Waivers to the inclusion criteriaInclusion criteriaThe things you must have or be for a study to consider you.Read more → will NOT be allowed.
• +For participants of child-bearing potential (menstruation within \<2 years): negative serum pregnancy test within 14-days prior to enrollmentEnrolmentThe number of participants a study plans to include, or has included.Read more → and must be willing to use Health Canada-approved effective contraception methods (e.g., hormonal contraceptives, intrauterine device or system, tubal ligation, or double barrier method) starting 1 week prior to study treatment, throughout the study, and for 6 months following the last dose of SG.
• +i. Prior bilateral oophorectomy ii. Age \> 60 iii. Age \< 60 with \>12 months of spontaneous amenorrhea (not due to chemotherapy, tamoxifen, toremifene, or ovarian suppression) and laboratory confirmation of postmenopausal FSH and estradiol levels per local postmenopausal reference ranges iv. Ovarian suppression with gonadotropin-releasing hormone (GnRH) agonist (e.g., goserelin) initiated \>28 days before Cycle 1 Day 1
• +Advanced (locoregionally recurrent and non-operable, or metastatic) triple-negative breast cancer patients not amenable to curative therapy (surgery and/or radiotherapy), including those who are PDL1 negative (combined positive score \[cps\] \<10), immuno-oncology therapy ineligible, or who had early-relapse after neoadjuvant therapy and not eligible for immuno-oncology in the first-line setting.
• +Participants can have measurable or non-measurable disease by CT or MRI as per RECIST Version 1.1 criteria as evaluated locally. Tumour lesions situated in a previously irradiated area are considered measurable if unequivocal progression has been documented in such lesions since radiation. All radiology studies must be performed within 28-days of Day 1 Cycle 1.