This is an open-label, single arm, non-randomized, multicenter phase II study for the identification of predictive biomarkers of sacituzumab govitecan benefit and the understanding of key resistance mechanisms in HR+/HER2- advanced/metastatic breast cancer patients
Provision of signed and dated, written informed consent form prior to any mandatory study specific procedures, sampling, and analyses.
Patients must be male or female (pre/peri or postmenopausal) ≥ 18 years of age.
ECOG performance status of 0 or 1(see Appendix 1).
Histologically or cytologically confirmed breast cancer with evidence of locally advanced disease, not amenable to resection or radiation therapy with curative intent or metastatic disease.
Patients with HER2-positive or TNBC disease.
Other malignancy unless curatively treated with no evidence of disease for ≥3 years except: non-melanoma skin cancer, in situ cancer of the cervix, ductal carcinoma in situ (DCIS), Stage 1, grade 1 endometrial carcinoma or other malignant tumors with an expected curative outcome after medical monitor approval.
Has unresolved toxicities from previous anticancer therapy (≥ CTCAE version 5.0 grade 1) caused by previous cancer therapy, excluding alopecia or other toxicities not considered a safety risk for the patient at investigator's discretion. Note: Subjects may be enrolled with chronic, stable Grade 2 toxicities (defined as no worsening to ≥Grade 2 for at least 2 months prior to enrollment and managed with standard of care treatment) that the investigator deems related to previous anticancer therapy, such as: Chemotherapy-induced neuropathy, Fatigue, Residual toxicities from prior IO treatment Grade 1 or Grade 2 endocrinopathies. Note: if patients received major surgery, they must have recovered adequately from the toxicity and/or complications from the intervention prior to starting therapy.
Patients may not be participating in a study with an investigational agent or investigational device within 2 weeks or 5 half-lives, whichever is longer, prior to allocation. Patients participating in observational studies are eligible.
Single group
Sacituzumab Govitecan
DrugSacituzumab Govitecan 10 mg/kg will be administrad intravenously (IV) on Days 1, 8 of a 21-day cycle
CelTIL score
Mean change in CelTIL score per central assessment between paired tumor samples in the overall population. CelTIL score = -0.8 x tumor cellularity (%) + 1.3 x tumor-infiltrating lymphocytes (TILs) (%). The minimum and maximum unscaled CelTIL scores will be -80 and 130. This unscaled CelTIL score will then be scaled to reflect a range from 0 to 100 points.
Overall Response rate (ORR)
proportion of patients with measurable disease with best overall response of complete response (CR) or partial response (PR), as per local investigator´s assessment and according to Response Evaluation Criteria in Solid Tumors (RECIST) version 1.1 criteria.
Clinical Benefit Rate (CBR)
Proportion of patients with a best overall response of CR, PR or an overall lesion response of Stable Disease (SD) or Non- PR/Non-progression disease (PD) lasting ≥24 weeks, based on local investigator´s assessment according to RECIST v1.1.
Progression free survival (PFS)
Time from enrollment to the first occurrence of disease progression, as determined locally by the investigator through the use of RECIST v.1.1, or death from any cause, whichever occurs first.
Duration of response (DoR)
Time from the first occurrence of a documented objective response to disease progression, as determined locally by the investigator through use of RECIST v.1.1, or death from any cause, whichever occurs first.
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