Status and phase
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About
The purpose of this research study is to see if the medication sacituzumab govitecan (SG) is effective at the currently approved dose and schedule in people who have previously received trastuzumab deruxtecan (T-DXd) for the treatment of metastatic, hormone receptor positive (HR+)/human epidermal growth factor 2 low (HER2 low) breast cancer. Although SG is approved to treat metastatic HR+/HER2 negative breast cancer, the aim of this study is to determine if SG is still effective specifically in people who have already received T-DXd.
Enrollment
Sex
Ages
Volunteers
Inclusion criteria
Provision of signed and dated informed consent form.
Stated willingness to comply with all study procedures and availability for the duration of the study.
Individuals ≥ 18 years of age.
Histologically confirmed metastatic or advanced and unresectable breast cancer that is HER2-low breast cancer (BC) by local testing with documented evidence of HR+/HER2-low defined as: [immunohistochemistry (IHC) 2+/in situ hybridization (ISH)- or IHC 1+ (ISH- or untested)] on either the primary or any metastatic site.
Histologically confirmed metastatic or advanced and unresectable breast cancer that is estrogen receptor and/or progesterone receptor positive defined as >1% on any metastatic site or the primary tumor.
Endocrine-refractory (as per investigator judgement) and may have received any number of prior endocrine therapies (alone or in combination with cyclin-dependent kinase (CDK)4/6 inhibitor, everolimus, alpelisib, acapivasertib or inavolisib).
Received a CDK4/6 inhibitor either alone or in combination with endocrine therapy (in the adjuvant or metastatic setting) with any duration of therapy permitted.
Received at least 1 but no more than 4 prior systemic chemotherapy regimens in the metastatic setting. Prior ADCs count as a line of systemic therapy.
Prior treatment with T-DXd (discontinued for progression and/or intolerance), which does not have to be the treatment immediately prior to enrollment on trial.
Documented clinical and/or radiographic disease progression after most recent therapy, unless immediate prior therapy was T-DXd which was discontinued for toxicity.
Measurable disease, as per RECIST V1.1
Eastern Cooperative Oncology Group (ECOG) Performance Status (PS) ≤ 2.
Adequate organ and bone marrow function within 28 days before enrollment. For all parameters listed below, the most recent results available must be used:
Adequate treatment washout period before randomization, defined as:
Evidence of post-menopausal status or for individuals of childbearing potential must have a negative serum beta-human chorionic gonadotropin (ß-hCG) at screening or baseline. Individuals of childbearing potential are defined as those who are not surgically sterile (i.e., underwent bilateral tubal occlusion, bilateral salpingectomy, bilateral oophorectomy, or complete hysterectomy) or post-menopausal.
Individuals of childbearing potential who are sexually active with a non-sterilized male partner must agree to use at least one highly effective method of contraception from the time of registration through final study treatment. Not all methods of contraception are highly effective.
Non-sterilized male patients who are sexually active with a partner of childbearing potential must agree to use a condom with spermicide from registration and throughout duration of the study treatment.
The following are acceptable measures to prevent pregnancy:
Exclusion criteria
Primary purpose
Allocation
Interventional model
Masking
75 participants in 1 patient group
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Central trial contact
Reshma L Mahtani, D.O.; Krystal Fernandez
Data sourced from clinicaltrials.gov
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