Sacituzumab Govitecan in HR-positive HER2-negative metastatic breast cancer

Nardin, Simone; Mastro, Lucia Del

doi:10.21037/atm-22-6266

Cited by 2 publications

(1 citation statement)

References 16 publications

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“…One such example is the IMMU-132-01 study (NCT01631552), an open-label basket trial that evaluated the safety and efficacy of Sacituzumab Govitecan-hziy across multiple solid tumors, including metastatic triple-negative breast cancer (TNBC). The study demonstrated promising results in the treatment of previously treated metastatic TNBC ( 20 ), thereby demonstrating the potential of the basket trial design in extending our understanding of drug effects across various cancer types.…”

Section: The Evolution Of Clinical Trial Design In Breast Cancermentioning

confidence: 88%

Types and progress of clinical trial design for breast cancer: a narrative review

Zhou,

Zhang

2023

Transl Breast Cancer Res

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Background and Objective In recent years, the field of breast cancer diagnosis and therapy has witnessed rapid technological advances. Concurrently, the emergence of molecular biology and novel detection methodologies has facilitated the transition of breast cancer management into the precision medicine era. The primary objective of this review is to discuss the transformation in the research and development paradigm for breast cancer therapies and strategies. Methods We systematically searched PubMed, EMBASE and Cochrane databases for relevant studies published over the past 20 years using keywords including “breast cancer”, “clinical trial”, “seamless”, “master protocol”, “umbrella”, “basket”, “platform”, and “precision medicine”. Articles were screened for eligibility and key data extracted. The search was limited to English-language publications. Key Content and Findings The review identifies three core innovations in breast cancer trial methodology: (I) in terms of research speed, the traditional three-stage drug development models are being substituted by “seamless designs” as exemplified by the immunotherapy combination study NCT0328056. (II) Addressing research breadth, “master protocols” such as basket trials (IMMU-132-01), umbrella trials (FUTURE), and platform trials (I-SPY 2) have been introduced, allowing the simultaneous assessment of multiple treatments or disease subtypes within a singular framework. (III) Pertaining to research precision, newer designs utilize biomarkers such as “enrichment” (seen in EMBRACA and OlympiA trials) and “marker stratification” (as in the SOLAR-1 trial), enabling the identification of appropriate patient subgroups and the provision of tailored therapy strategies, a stark contrast to traditional histopathology-based evaluations. Conclusions Clinical trial design in breast cancer research has been revolutionized, moving towards more efficient and targeted strategies. Despite the presence of ethical, logistical, and data complexities, it is anticipated that ongoing technological and regulatory enhancements will pave the way for even more refined research approaches, subsequently influencing future research, clinical practices, and policymaking in breast cancer care.

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Section: The Evolution Of Clinical Trial Design In Breast Cancermentioning

confidence: 88%

Types and progress of clinical trial design for breast cancer: a narrative review

Zhou,

Zhang

2023

Transl Breast Cancer Res

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Efficacy of Sacituzumab Govitecan in Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer

Qureshi,

Jamil,

Fatima

et al. 2024

American Journal of Clinical Oncology

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Objectives: Breast cancer is the most diagnosed cancer in women, with hormone receptor-positive/human epidermal growth factor receptor 2-negative (HR+/HER2–) being the predominant subtype. Sacituzumab govitecan (SG), a novel antibody-drug conjugate, has emerged as a promising treatment for metastatic HR+/HER2– breast cancer. This systematic review and meta-analysis aimed to evaluate its efficacy and safety. Methods: Adhering to “Preferred Reporting Items for Systematic Reviews and Meta-Analyses” guidelines, a comprehensive search was conducted in PubMed, Scopus, and Cochrane databases up to December 2023. We included clinical trials and observational studies evaluating SG in patients with HR+/HER2– advanced breast cancer. The primary outcome was progression-free survival (PFS). In contrast, the secondary outcomes included overall survival, objective response rate, clinical benefit rate, duration of response (DOR), and adverse event profiles. Review Manager (Version 5.4) was used for the statistical analysis. Results: Nine studies met the inclusion criteria for systematic review; 2 were suitable for meta-analysis. The pooled analysis showed a hazard ratio of 0.53 (95% CI: 0.34-0.83; P= 0.005; I 2 = 86%) for PFSl and a hazard ratio of 0.63 (95% CI: 0.36-1.11; P= 0.11; I 2 = 92%) for overall survival. The pooled analysis of the duration of response showed significant results with a standard mean difference = 0.22 (95% CI: 0.03-0.42; P = 0.02; I 2 = 61%). Conclusion: SG demonstrates significant benefit in PFS and duration of response in patients of HR+/HER2– advanced breast cancer.

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Sacituzumab Govitecan in HR-positive HER2-negative metastatic breast cancer

Cited by 2 publications

References 16 publications

Types and progress of clinical trial design for breast cancer: a narrative review

Types and progress of clinical trial design for breast cancer: a narrative review

Efficacy of Sacituzumab Govitecan in Hormone Receptor–Positive/Human Epidermal Growth Factor Receptor 2–Negative Advanced Breast Cancer

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