Actively Recruiting
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
Led by Shandong Suncadia Medicine Co., Ltd. · Updated on 2025-03-17
102
Participants Needed
1
Research Sites
124 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
The study is being conducted to evaluate the safety and tolerability of HRS-1358 monotherapy or combination with Dalpiciclib Isethionate Tablets in patients with metastatic or locally advanced breast cancer in order to estimate the Dose-Limiting Toxicity (DLT), Maximum Tolerated Dose (MTD) and select the Recommended Phase 2 Dose (RP2D).
CONDITIONS
Official Title
A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Histologically confirmed locally advanced or metastatic breast cancer
- Female participants who are postmenopausal or pre-/peri-menopausal on ovarian suppression
- Received at least one line of endocrine therapy for metastatic or advanced breast cancer
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1
- Adequate organ function as defined by study requirements
- Ability to understand and voluntarily provide written informed consent
You will not qualify if you...
- Investigator judgment that participant is unsuitable for endocrine therapy
- Active brain metastasis without medical control or with clinical symptoms
- History of significant cardiovascular or cerebrovascular diseases
- Conditions affecting oral drug absorption, distribution, metabolism, or excretion
- Active autoimmune diseases or history of immunodeficiency, including positive HIV test or organ transplantation
- Prior treatment with similar drugs
- Known allergy to ingredients of HRS-1358
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
Beijing, Beijing Municipality, China, 100021
Actively Recruiting
Research Team
X
Xia Zhang
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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