A Phase III Trial Comparing HRS-8080 With Standard Endocrine Therapy in Patients With High-Risk Early Breast Cancer

NCT07349069 | Recruiting Phase 3

• 1 other identifier: HRS-8080-305
• Study Type: interventional
• Target: 4,800
• Locations: 1 country
• Sites: 2

Brief Summary

The study is being conducted to evaluate the efficacy and safety of HRS-8080 in patients with high-risk early breast cancer.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• The time from the date of randomization to the first occurrence of any of the following events: ipsilateral local or contralateral invasive recurrence, distant recurrence, or death from any cause.

  Invasive Breast Cancer-Free Survival (IBCFS).

  Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.

Secondary Outcomes (3)

• Invasive Disease-Free Survival (IDFS).

  Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.

• Distant Metastasis-Free Survival (DRFS).

  Every 26 weeks for the first 104 weeks after randomization, and then every 52 weeks thereafter, up to 5 years.

• Overall Survival (OS).

  Survival follow-up every 3 months, up to 5 years.

Study Arms (2)

HRS-8080 Group

EXPERIMENTAL

HRS-8080 tablets group.

Drug: HRS-8080 Tablets

Letrozole or Tamoxifen Citrate Group

ACTIVE COMPARATOR

Letrozole tablets or Tamoxifen Citrate tablets group.

Drug: Letrozole tablets; Drug: Tamoxifen Citrate Tablets

Interventions

HRS-8080 Tablets DRUG

HRS-8080 tablets.

HRS-8080 Group

Letrozole tablets DRUG

Letrozole tablets.

Letrozole or Tamoxifen Citrate Group

Tamoxifen Citrate Tablets DRUG

Tamoxifen Citrate tablets.

Letrozole or Tamoxifen Citrate Group

Eligibility Criteria

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

You may qualify if:

• Female patients aged ≥ 18 and ≤ 75 years with clinical stage II-III disease. Premenopausal patients must be willing to receive LHRH agonist therapy during the study period.
• Histologically confirmed invasive breast cancer by postoperative pathology, having received at least 2 years, but no more than 5 years, of adjuvant endocrine therapy.
• No evidence of recurrent or metastatic disease after surgery.
• ECOG performance status of 0 or 1.
• Adequate organ and bone marrow function.
• Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and be willing to use acceptable non-hormonal contraception methods from the time of informed consent until 7 months after the last dose of the study drug.
• Any acute toxicities from previous anti-tumor therapy have resolved to Grade 0-1 (per CTCAE v5.0).
• The patient has provided written informed consent (ICF), and is willing and able to comply with scheduled visits, treatment plans, laboratory tests, and other study procedures.

You may not qualify if:

• Tumor clinical stage IV (metastatic) breast cancer.
• History and/or treatment of any malignancy other than breast cancer within 5 years prior to randomization.
• History of severe pulmonary disease, such as interstitial lung disease.
• Concurrent or potential use of any anti-tumor therapy not specified in the study protocol.
• Major surgical procedure within 4 weeks prior to randomization.
• HIV infection or known AIDS, active hepatitis B, hepatitis C, or co-infection with hepatitis B and C.
• Poor cardiac function.
• Severe infection within 4 weeks prior to randomization.
• History of drug allergy.
• History of organ transplantation.
• History of substance abuse.
• Women within 1 year postpartum or who are currently breastfeeding.
• Patients deemed by the investigator as unsuitable for participation in this study.

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

Study Sites (2)

The First Affiliated Hospital of Nanjing Medical University

Nanjing, Jiangsu, 210029, China

RECRUITING

Fudan University Shanghai Cancer Center

Shanghai, Shanghai Municipality, 200032, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Letrozole; Tamoxifen

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons

Central Study Contacts

Yue He

CONTACT

+86-0518-82342973; yue.he.yh58@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 9, 2026
• First Posted: January 16, 2026
• Study Start: March 4, 2026
• Primary Completion (Estimated): December 1, 2030
• Study Completion (Estimated): January 1, 2034
• Last Updated: March 19, 2026

Record last verified: 2026-03

Locations

CN (2)