A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

NCT07024173 | Recruiting Phase 3

• 1 other identifier: HRS-8080-303
• Study Type: interventional
• Target: 240
• Locations: 1 country
• Sites: 2

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.

Conditions

Locally Advanced Breast Cancer; Metastatic 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.

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 tablets; Drug: Everolimus Tablets

Exemestane or Anastrozole or Letrozole Group

ACTIVE COMPARATOR

Drug: Exemestane tablets; Drug: Anastrozole Tablets; Drug: Letrozole Tablets

Interventions

HRS-8080 Tablet DRUG

HRS-8080 tablet orally administered.

HRS-8080 Group

Fulvestrant injection DRUG

Fulvestrant injection.

Fulvestrant Group

Exemestane tablets DRUG

Exemestane tablets orally administered.

Exemestane in combination with Everolimus Group; Exemestane or Anastrozole or Letrozole Group

Everolimus Tablets DRUG

Everolimus tablets orally administered.

Exemestane in combination with Everolimus Group

Anastrozole Tablets DRUG

Anastrozole tablets orally administered.

Exemestane or Anastrozole or Letrozole Group

Letrozole Tablets DRUG

Letrozole tablets orally administered.

Exemestane or Anastrozole or Letrozole 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:

• 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.
• Patients received no more than one line of chemotherapy in the recurrence/metastasis stage.
• Menstrual status (meeting any of the following conditions) : a) After bilateral ovariectomy; b) Age ≥60 years old; c) Age \< 60 years old, natural menopause ≥12 months, without receiving chemotherapy, tamoxifen (TAM), tolemiphene or ovarian castration in the past year, follicle-stimulating hormone (FSH) and estradiol are within the postmenopausal range; d) For patients under the age of 60 who are taking TAM or tolemiphene, the levels of FSH and estradiol are within the postmenopausal range; e) Premenopausal or perimenopausal patients received luteinizing hormone-releasing hormone (LHRH) agonist treatment during the study period, and the treatment was initiated at least 14 days before the start of the study.
• Patients comply with any of the following provisions of the RECIST v1.1 standard: a) There is at least one extracranial measurable lesion; b) If there are no measurable lesions as stipulated above, at least one osteolytic or mixed (osteolytic and osteogenic) bone lesion that can be evaluated by computed tomography (CT) or magnetic resonance imaging (MRI) exists.
• Expected survival \> 6 months.
• The functional level of the organs must meet the requirements.
• Female with fertility must agree to use effective contraceptive measures for contraception during the study treatment period and within 7 months after the end of the study treatment period; Femalewith fertility must have a negative serum human chorionic gonadotropin (hCG) test within 7 days before enrollment in the study and must be in the non-lactation period.
• 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 previously received other systemic anti-tumor treatments besides chemotherapy、endocrine therapy and CDK4/6i (prior use of PI3K inhibitors or AKT inhibitors is permitted for patients with known PIK3CA mutations or PIK3CA/AKT/PTEN alterations).
• Nitrosorea or mitomycin was received within 6 weeks before the first study administration in this study; Have undergone major organ surgery, cytotoxic drugs, immunotherapy, , anti-tumor traditional or Chinese medicine medications within 4 weeks before the first study administration and within 4 weeks or 5 half lives (whichever is shorter) prior to the first study drug administration ; Have received endocrine therapy (referring to aromatase inhibitors \[AI\], etc.) and palliative radiotherapy within 2 weeks before the first study administration.
• the date from the first study administration to the last CYP3A4 strong inducer administration is less than 28 days.
• Patients with rapid disease progression and investigators determines that endocrine therapy is not suitable or tolerant.
• Patients with active (uncontrolled by medical treatment or with clinical symptoms) brain metastases, cancerous meningitis, spinal cord compression, or a history of primary central nervous system tumors; Patients with brain metastases who have completed treatment at least 28 days before the first study administration, have stable symptoms and do not require hormone therapy may be enrolled as appropriate, but they must be confirmed to have no cerebral hemorrhage by cranial imaging examinations such as CT, MRI or venography.
• A history of severe clinical cardiovascular diseases.
• Patients with uncontrollable tumor-related pain as judged by investigators. Patients who need pain-relieving medication must have a stable pain-relieving medication plan before entering the study.
• Patients who have received immunosuppressant or systemic hormone therapy for immunosuppression within 2 weeks prior to the first medication (dose \> 10 mg/d prednisone or other corticosteroid hormones of equivalent physiological dose), excluding nasal sprays or inhaled hormones.
• The damage caused by other treatments previously received by patients did not recover to grade ≤1 in the Common Terminology Criteria for Adverse Events of the National Cancer Institute of the United States, Version 5.0 (NCI CTCAE v5.0) (excluding alopecia and other adverse events judged tolerable by investigators).
• Severe infection exists within 4 weeks before the first study administration, including but not limited to infectious complications requiring hospitalization, bacteremia, severe pneumonia, etc. There was an active infection of CTCAE grade ≥2 requiring intravenous antibiotic treatment within 2 weeks before the first study administration.
• Patients with arterial/venous thrombotic events that occurred within 6 months before the first study administration, such as cerebrovascular accidents, deep vein thrombosis and pulmonary embolism, etc.
• Patients with clinically significant endometrial abnormalities, including but not limited to endometrial hyperplasia and dysfunctional uterine bleeding.
• Untreated active hepatitis.
• Patients with other malignant tumors within the past 5 years or is currently suffering from them, except for cancers with an extremely low risk of recurrence, including but not limited to radical cervical carcinoma in situ, cutaneous basal cell carcinoma and squamous cell carcinoma, and surgically treated papillary thyroid carcinoma, etc.
• Patients with hereditary or acquired bleeding tendency (such as hemophilia, coagulation dysfunction, etc.).

Sponsors & Collaborators

• Shandong Suncadia Medicine Co., Ltd.: lead

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

Fulvestrant; exemestane; Everolimus; Anastrozole; Letrozole

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Estradiol; Estrenes; Estranes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Sirolimus; Macrolides; Lactones; Organic Chemicals; Nitriles; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Central Study Contacts

Min Li

CONTACT

+86-0518-82342973; min.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): August 1, 2027
• Study Completion (Estimated): December 1, 2027
• Last Updated: October 2, 2026

Record last verified: 2026-09

Locations

CN (2)