NCT07024173

Brief Summary

This study is a multicenter, open-label, randomized controlled Phase 3 clinical trial. It is planned to enroll 240 female patients with locally advanced or metastatic breast cancer followed by disease progression after previous endocrine therapy.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
240

participants targeted

Target at P50-P75 for phase_3

Timeline
19mo left

Started Jul 2025

Geographic Reach
1 country

2 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress34%
Jul 2025Dec 2027

First Submitted

Initial submission to the registry

June 9, 2025

Completed
8 days until next milestone

First Posted

Study publicly available on registry

June 17, 2025

Completed
1 month until next milestone

Study Start

First participant enrolled

July 23, 2025

Completed
1.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2026

Expected
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2027

Last Updated

January 26, 2026

Status Verified

January 1, 2026

Enrollment Period

1.4 years

First QC Date

June 9, 2025

Last Update Submit

January 22, 2026

Conditions

Locally Advanced Breast CancerMetastatic Breast Cancer

Outcome Measures

Primary Outcomes (1)

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

    Approximately 2 years.

Secondary Outcomes (7)

  • Progression free survival (PFS) evaluated by investigators.

    Approximately 2 years.

  • Overall response rate (ORR).

    Approximately 2 years.

  • Clinical benefit rate (CBR).

    Approximately 2 years.

  • Duration of response (DOR).

    Approximately 2 years.

  • Overall survival (OS).

    Approximately 3 years.

  • +2 more secondary outcomes

Study Arms (4)

HRS-8080 Group

EXPERIMENTAL
Drug: HRS-8080 Tablet

Fulvestrant Group

ACTIVE COMPARATOR
Drug: Fulvestrant injection

Exemestane in combination with Everolimus Group

ACTIVE COMPARATOR
Drug: Exemestane tabletsDrug: Everolimus Tablets

Exemestane or Anastrozole or Letrozole Group

ACTIVE COMPARATOR
Drug: Exemestane tabletsDrug: Anastrozole TabletsDrug: Letrozole Tablets

Interventions

HRS-8080 TabletDRUG

HRS-8080 tablet orally administered.

HRS-8080 Group
Fulvestrant injectionDRUG

Fulvestrant injection.

Fulvestrant Group
Exemestane tabletsDRUG

Exemestane tablets orally administered.

Exemestane in combination with Everolimus GroupExemestane or Anastrozole or Letrozole Group
Everolimus TabletsDRUG

Everolimus tablets orally administered.

Exemestane in combination with Everolimus Group
Anastrozole TabletsDRUG

Anastrozole tablets orally administered.

Exemestane or Anastrozole or Letrozole Group
Letrozole TabletsDRUG

Letrozole tablets orally administered.

Exemestane or Anastrozole or Letrozole Group

Eligibility Criteria

Age18 Years - 75 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Women aged 18 to 75 years old (including both values).
  • ECOG Physical Strength Status (PS) : 0 to 1 point.
  • Patients with locally advanced or metastatic breast cancer confirmed by histology.
  • Patients previously received 1-2 lines of endocrine therapy.
  • Expected survival \> 6 months.
  • The functional level of the organs must meet the requirements.
  • Subjects that voluntarily participate in this clinical trial, be willing and able to abide by the procedures related to clinical visits and research, understand the research procedures and have signed the informed consent.

You may not qualify if:

  • Patients with rapid disease progress and investigators determine that endocrine therapy is not suitable or tolerant.
  • A history of severe clinical cardiovascular diseases.
  • Patients with uncontrollable tumor-related pain as judged by investigators.
  • Severe infection exists within 4 weeks before the first study administration.
  • Patients with clinically significant endometrial abnormalities.
  • Untreated active hepatitis.
  • Patients known to be allergic to HRS-8080 components.
  • Pregnant and lactating women, or those planning to become pregnant during the study period.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Sun Yat-sen University Cancer Center

Guangzhou, Guangdong, 510000, China

RECRUITING

Hunan Cancer Hospital

Changsha, Hunan, 410000, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

FulvestrantexemestaneEverolimusAnastrozoleLetrozole

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

EstradiolEstrenesEstranesSteroidsFused-Ring CompoundsPolycyclic CompoundsEstradiol CongenersGonadal Steroid HormonesGonadal HormonesHormonesHormones, Hormone Substitutes, and Hormone AntagonistsSirolimusMacrolidesLactonesOrganic ChemicalsNitrilesTriazolesAzolesHeterocyclic Compounds, 1-RingHeterocyclic Compounds

Central Study Contacts

Min Li

CONTACT

+86-0518-82342973min.li.ml150@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

June 9, 2025

First Posted

June 17, 2025

Study Start

July 23, 2025

Primary Completion (Estimated)

December 1, 2026

Study Completion (Estimated)

December 1, 2027

Last Updated

January 26, 2026

Record last verified: 2026-01

Locations

CN(2)