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A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Efficacy of SIM0270 Alone or in Combination in Subjects With ER-positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer

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Trial Profile

A Multicenter, Open-label, Phase I Clinical Study to Evaluate the Safety, Pharmacokinetics, and Antitumor Efficacy of SIM0270 Alone or in Combination in Subjects With ER-positive, HER-2 Negative Locally Advanced or Metastatic Breast Cancer

Status: Active, no longer recruiting
Phase of Trial: Phase I

Latest Information Update: 17 Mar 2025

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At a glance

  • Drugs Everolimus (Primary) ; Palbociclib (Primary) ; SCR-6852 (Primary)
  • Indications Advanced breast cancer; HER2 negative breast cancer; Male breast cancer
  • Focus Adverse reactions; First in man
  • Sponsors Jiangsu Simcere Pharmaceutical

Most Recent Events

  • 28 Nov 2024 Status changed from recruiting to active, no longer recruiting.
  • 09 Dec 2023 According to Simcere Pharmaceutical media release, preliminary findings from this study were presented in the POSTER SPOTLIGHT session in the form of mini oral presentation at 46th San Antonio Breast Cancer Symposium (SABCS) held from December 5th to 9th local time in San Antonio, Texas, USA.
  • 26 May 2023 Number of arms changed from 2 to 3. Experimental arm SIM0270+everolimus added to study protocol. Efficacy endpoint has been removed from primary outcome measures. Planned number of patients also increased.

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