Phase 3 Study of Sacituzumab Govitecan (IMMU-132) Versus Treatment of Physician's Choice (TPC) in subjects with Hormonal Receptor-Positive (HR+) Human Epidermal Growth Factor Receptor 2 (HER2) Negative Metastatic Breast Cancer (MBC) who have failed at least two prior chemotherapy regimens - Phase 3 Study of Sacituzumab Govitecan (IMMU-132) in Relapsed/Refractory HR+/HER2- MBC

Gilead Sciences Inc.0 个研究点目标入组 520 人开始时间: 2019年6月11日最近更新: 2023年12月19日

适应症

试验速览

阶段: 1 期
状态: 进行中（未招募）
发起方: Gilead Sciences Inc.
入组人数: 520

研究概览入排标准研究者记录与标识符相似试验

研究概览

简要总结

暂无简介。

研究设计

研究类型: Interventional clinical trial of medicinal product

入排标准

性别: All

入选标准

•1. Female or male subjects adult or aged =18 years at the time of signing the informed consent form (ICF).
•2. Documented evidence of HR+/HER2-MBC confirmed by a local laboratory with the most recently available or newly obtained tumor biopsy (preferably within the last 12 months) from a locally recurrent or metastatic site(s) and defined per ASCO/CAP criteria as: HR positive and HER2-negative.
•3. Availability of archival tumor tissue in a formalin-fixed, paraffin embedded (FFPE) block (preferably within 12 months prior to consent) or newly acquired biopsy (FFPE block) from a metastatic site. Note: bone biopsies are not allowed
•4. Refractory to or relapsed after at least 2, and no more than 4, prior systemic chemotherapy regimens for MBC.
•5. Should have been previously treated with:
•- At least 1 taxane in any setting.
•- At least 1 prior anticancer hormonal treatment in any setting
•- At least 1 cyclin-dependent kinase inhibitor 4/6 in any setting.
•6. Eligible for one of the chemotherapy options listed in the TPC arm.
•7. Documented disease progression after the most recent therapy by CT/MRI
•8. At least 1 measurable target lesion according to RECIST 1.1 (bony disease only is not allowed) meeting all of the following criteria:
•- Lymph node lesion that measures at least =1.5 cm in the short axis.
•- Non-nodal lesion that measures =1.0 cm in the longest diameter in the plane of measurement
•- The lesion is suitable for repeat measurement using CT/MRI.Historical
•CT/MRI scans performed within 28 days of C1D1 may be used as
•screening scans to demonstrate eligibility by local radiology review as
•long as they meet minimum standards as separately defined by the central imaging vendor.
•- Lesions that have had external beam radiotherapy or locoregional therapy must show radiographic evidence of disease progression based on RECIST 1.1 to be deemed a target lesion.
•- Brain CT/MRI must be conducted for subjects with a history of brain metastasis. The subject must have had stable* brain metastasis for at least 4 weeks. Target lesions cannot be from brain.
•* Stable brain metastasis is defined as the following:
•- Prior local treatment by radiation, surgery, or stereotactic surgery.
•- Imaging – stable or decreasing size after such local treatment.
•- Clinically stable signs and symptoms for at least 4 weeks.
•- =2 weeks from discontinuation of antiseizure medication
•- Low and stable doses of corticosteroids =20 mg prednisone or equivalent daily are permitted
•9. ECOG performance status of 0 or 1
•10. Adequate renal function: calculated creatinine clearance =30 mL/minute according to the Cockcroft and Gault formula
•11. Adequate bone marrow function
•Note: Blood transfusion or growth factor support is not allowed within 14 days prior to screening labs.
•12. Adequate liver function.
•13. Resolution of all systemic anticancer therapy-related or radiation-related toxicities to Grade 1 severity or lower, except for neuropathy (=Grade 2) and alopecia. Subjects with Grade 2 neuropathy are eligible but may not receive vinorelbine as TPC.
•14. Females must not be lactating or pregnant at Baseline (as documented by a negative ß-hCG or hCG) test. .
•- All females will be considered to be of childbearing potential unless they are postmenopausal or have been sterilized surgically.
•15. Females of childbearing potential must not have had unprotected sexual intercourse within 30 days before study entry and must agree to use a highly effective method of contraception throughout the e

排除标准

•1. Previous treatment with a topoisomerase 1 inhibitor as a free form or as other formulations
•2. Current enrollment in another clinical study or used any investigational device or drug either within 5 half-lives or 28 days prior to randomization, whichever is longer
•3. Treatment with chemotherapy, radiation, or small molecule targeted therapy within 2 weeks and biological therapy within 4 weeks prior to the first dose of study treatment
•4. Existing anticancer treatment-related AEs of Grade =2 (except for alopecia and Grade 2 neuropathy) according to NCI-CTCAE v5.0.
•5. Any other malignancy that required treatment or has shown evidence of recurrence (except for non-melanoma skin cancer, or histologically confirmed complete excision of carcinoma in situ) during the 5 years prior to enrollment in this study.
•6. History of significant cardiovascular disease, defined as:
•- Congestive heart failure greater than New York Heart Association (NYHA) Class II according to the NYHA Functional Classification.
•- Unstable angina or myocardial infarction within 6 months before enrollment.
•- Serious cardiac arrhythmia.
•7. Clinically significant ECG abnormality, including:
•- Marked Baseline prolonged QT/QTc interval (ie, a repeated Screening.
•- History of risk factors for torsade de pointes (eg, heart failure, hypokalemia, family history of long QT Syndrome).
•8. Has known active central nervous system metastases and/or carcinomatous meningitis. Subjects may participate provided they have stable brain metastasis. All subjects with carcinomatous meningitis are excluded regardless of clinical stability. Stable brain metastasis is defined in inclusion criterion 8
•9. Active hepatitis B virus (positive hepatitis B surface antigen) or active hepatitis C virus (measurable viral ribonucleic acide (RNA) load with polymerase chain reaction) infection.
•10. Scheduled surgery during the study, other than minor surgery which would not delay study treatment.
•11. Has an active serious infection requiring antibiotics
•12. Has active chronic inflammatory bowel disease (ulcerative colitis, Crohn's disease) and subjects with a history of bowel obstruction.
•13. Have received a live vaccine within 30 days of randomization.
•14. Known hypersensitivity or intolerance to any of the study drugs or any of the excipients.
•15. Any medical or other condition which, in the opinion of the Investigator, causes the subject to be medically unfit to receive sacituzumab govitecan or unsuitable for any other reason.
•16. Is receiving any medication prohibited in combination with the study treatment(s) as described in the respective product labels, unless medication was stopped within 7 days prior to randomization.
•17. Locally-advanced MBC (stage IIIc) in subjects who are candidates for curative intent therapy at the time of study enrollment.
•18. If required per local guidelines, any subject with a blood uracil level = 150 ng/mL is excluded from receiving capecitabine as TPC (Note: blood uracil level will be assessed at Screening for all subjects eligible to be randomized to capecitabine as TPC)

研究者

发起方

Gilead Sciences Inc.

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