HRS-1358 for Advanced Breast Cancer

A Trial of HRS-1358 Tablets in Metastatic or Local Advanced Breast Cancer

Recruiting Phase 1 Interventional Study
Breast Cancer
No Placebo Group Every participant receives an active treatment — no one gets a placebo.
Ready to participate?

Review the details below, then apply to join this clinical trial.

At a Glance
Age
18 – 75
Sex
Female
Trial phase
Phase 1
Study type
Interventional
Purpose
Treatment
Participants needed
102 (estimated)
Sponsor
Shandong Suncadia Medicine Co., Ltd. · Industry
Who this trial is looking for

This trial is looking for women with advanced or metastatic breast cancer. Participants will take HRS-1358 alone or with another medication to assess safety and tolerability.

Are You a Good Fit for This Trial?

You may be able to join if

  • I have been diagnosed with advanced or metastatic breast cancer.
  • I am a postmenopausal woman or on ovarian suppression.
  • I have received at least one line of endocrine therapy.
  • I have a good performance status score.
  • I have adequate organ functions.
  • I can understand and agree to participate in the study.

You may not be able to join if

  • I have been judged unsuitable for endocrine therapy.
  • I have active brain metastasis with symptoms.
  • I have a history of significant cardiovascular diseases.
  • I have conditions affecting drug absorption or metabolism.
  • I have an active autoimmune disease or a history of immunodeficiency.
  • I have received similar drugs in the past.
  • I am allergic to HRS-1358 ingredients.

Summarized in plain language from this trial's official eligibility criteria. The full criteria are further down this page — only the research team can confirm whether you qualify.

Think this trial could be right for you?

Answer a few quick questions to see if you may meet the eligibility requirements.

Check Your Eligibility
About This Trial

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).

Trial Locations
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Eligibility Criteria
Inclusion Criteria: 1. Histologically diagnosis of local advanced or metastatic breast cancer 2. Women must be postmenopausal, or pre-/peri-menopausal women must be on ovarian suppression 3. At least 1 line of endocrine therapy in the metastatic or advanced setting 4. ECOG performance status score:…
Contacts

Xia Zhang

+0518-81220121

Xia.zhang@hengrui.com

CONTACT