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NCT07354022 | RECRUITING | Locally Advanced or Metastatic Breast Cancer

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.
Sponsor:

Shandong Suncadia Medicine Co., Ltd.

Brief Summary:

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.

Condition or disease

Locally Advanced or Metastatic Breast Cancer

Intervention/treatment

HRS-8080 Tablet ; Dalpiciclib Isethionate

Fulvestrant injection ;Dalpiciclib Isethionate

Phase

PHASE3

Study Type : INTERVENTIONAL
Estimated Enrollment : 912 participants
Masking : NONE
Primary Purpose : TREATMENT
Official Title : A Multicenter, Open-label, Randomized Controlled Phase III Clinical Study Evaluating the Efficacy and Safety of HRS-8080 Combined With Dalpiciclib Versus Fulvestrant Combined With Dalpiciclib in Patients With Locally Advanced or Metastatic Breast Cancer Resistant to Adjuvant Endocrine Therapy.
Actual Study Start Date : 2026-03-04
Estimated Primary Completion Date : 2028-12
Estimated Study Completion Date : 2031-12

Information not available for Arms and Intervention/treatment

Ages Eligible for Study: 18 Years to 75 Years
Sexes Eligible for Study: FEMALE
Accepts Healthy Volunteers:
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 surgery;
  • 5. Menstrual status: postmenopausal, perimenopausal, or premenopausal;
  • 6. Presence of evaluable lesions;
  • 7. Organ function must meet required criteria.
Exclusion Criteria
  • 1. Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
  • 2. Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
  • 3. Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
  • 4. Patients with a history of clinically significant cardiovascular disease;
  • 5. Participants who have not recovered from adverse effects caused by prior therapies;
  • 6. Participants with a history of another malignancy within the past 5 years or currently having another malignancy;
  • 7. Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.
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.

Location Details

NCT07354022

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How to Participate

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Locations

RECRUITING

China, Beijing Municipality

Chinese PLA General Hospital Fifth Medical Center

Beijing, Beijing Municipality, China, 100000