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.

NCT07354022 | Recruiting Phase 3

• 1 other identifier: HRS-8080-301
• Study Type: interventional
• Target: 912
• Locations: 1 country
• Sites: 1

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.

Conditions

Locally Advanced or Metastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Investigator assessed Progression free survival (PFS)

  PFS is defined as the time from randomization to the first occurrence of PD, as determined by the investigator according to Response Evaluation Criteria in Solid Tumors Version 1.1 (RECIST v1.1), or death from any cause during the study.

  Up to 5 years.

Secondary Outcomes (12)

• Progression free survival (PFS) evaluated by the blinded independent central review (BICR)

  Up to 5 years

• Overall response rate (ORR)

  Up to 5 years

• Clinical benefit rate (CBR)

  Up to 5 years

• Duration of response (DOR)

  Up to 5 years

• Overall survival (OS)

  Up to 8 years

Study Arms (2)

HRS-8080 combined with Dalpiciclib

EXPERIMENTAL

Drug: HRS-8080 Tablet ; Dalpiciclib Isethionate

Fulvestrant combined with Dalpiciclib

ACTIVE COMPARATOR

Drug: Fulvestrant injection ;Dalpiciclib Isethionate

Interventions

HRS-8080 Tablet ; Dalpiciclib Isethionate DRUG

* HRS-8080 Tablet * Dalpiciclib Isethionate

HRS-8080 combined with Dalpiciclib

Fulvestrant injection ;Dalpiciclib Isethionate DRUG

* Fulvestrant injection * Dalpiciclib Isethionate

Fulvestrant combined with Dalpiciclib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Women aged 18 - 75 years old;
• Eastern Cooperative Oncology Group performance status (ECOG-PS) of 0 to 1;
• Patients with histologically confirmed locally advanced or metastatic breast cancer;
• Patients with prior adjuvant endocrine resistance following curative-intent surgery;
• Menstrual status: postmenopausal, perimenopausal, or premenopausal;
• Presence of evaluable lesions;
• Organ function must meet required criteria.

You may not qualify if:

• Patients with rapidly progressing disease, as judged by the investigator to be unsuitable for endocrine therapy;
• Patients who have previously received fulvestrant or other novel SERMs (excluding tamoxifen and toremifene);
• Patients with uncontrolled brain metastases, carcinomatous meningitis, or spinal cord compression;
• Patients with a history of clinically significant cardiovascular disease;
• Participants who have not recovered from adverse effects caused by prior therapies;
• Participants with a history of another malignancy within the past 5 years or currently having another malignancy;
• Known hypersensitivity to HRS-8080, fulvestrant, dalpiciclib, or any of their components, etc.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (1)

Chinese PLA General Hospital Fifth Medical Center

Beijing, Beijing Municipality, 100000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Central Study Contacts

Zhan Zhang

CONTACT

+86 17721286165; Zhan.zhang@hengrui.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 8, 2026
• First Posted: January 21, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): December 1, 2028
• Study Completion (Estimated): December 1, 2031
• Last Updated: March 27, 2026

Record last verified: 2026-01

Locations

CN (1)