A Study to Evluate Efficacy and Safety of HRS-8080 Combined With Dalpiciclib in Patients With Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
Recruiting
Phase 3
Interventional Study
Locally Advanced or Metastatic Breast Cancer
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 – 75
- Sex
- Female
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 912 (estimated)
- Sponsor
- Shandong Suncadia Medicine Co., Ltd. · Industry
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About This Trial
The study is being conducted to evaluate the efficacy and safety of HRS-8080 combined with dalpiciclib versus fulvestrant combined with dalpiciclib in patients with locally advanced/metastatic breast cancer who had developed drug resistance to prior adjuvant endocrine therapy.
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Women aged 18 - 75 years old;
2. Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
3. Patients with histologically confirmed locally advanced or metastatic breast cancer;
4. Patients with prior adjuvant endocrine resistance following curative-intent s…
Contacts