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 - IMMU-132-09

Gilead Sciences0 个研究点目标入组 15 人开始时间: 待定最近更新: 2024年6月18日

适应症

试验速览

阶段: 3 期
状态: 已完成
发起方: Gilead Sciences
入组人数: 15

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

入排标准

年龄范围: 18 至 99（—）

入选标准

•Subjects must meet all the following inclusion criteria:
•1. Female or male subjects, adult or aged >=18 years at the time of signing the
•informed consent form
•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 American Society of Clinical Oncologists/College of American Pathologists
•criteria as:
•HR+ (a tumor is considered HR+ if at least 1% of the cells examined have
•estrogen and/or progesterone receptors)
•HER2- defined as immunohistochemistry <=2+ or fluorescence in situ
•hybridization 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, but no more than 4 prior
•systemic chemotherapy regimens for metastatic disease. Adjuvant or neoadjuvant
•therapy for early stage disease will qualify as one of the required prior
•chemotherapy regimens if the development of unresectable, locally advanced, or
•metastatic disease occurred within a 12-month period of time of the therapy.
•Note: Treatments for bone metastases (eg, bisphosphonates, denosumab, etc.) and
•hormonal therapy are not considered as prior systemic chemotherapy treatments
•for advanced disease.
•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 CDK 4/6 inhibitor 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 computed
•tomography (CT)/magnetic resonance imaging (MRI)
•8. At least 1 measurable target lesion according to RECIST 1.1 (bony disease
•only is not allowed) that meets 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 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
另有 3 项未显示

排除标准

•Subjects who meet any of the following criteria will be excluded from the study:
•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 electrocardiogram (ECG) abnormality, including any of
•the following:
•Marked Baseline prolonged QT/QTc interval (i.e., a repeated demonstration of
•a QTc interval >500 ms) demonstrated on ECG at Screening.
•QTcF is calculated by Fridericia's formula
•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 RNA load with polymerase chain reaction)
•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.
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研究者

发起方

Gilead Sciences

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