---
title: A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer
nct_id: NCT07024173
overall_status: RECRUITING
phase: PHASE3
sponsor: Shandong Suncadia Medicine Co., Ltd.
study_type: INTERVENTIONAL
primary_condition: Locally Advanced Breast Cancer
countries: China
canonical_url: "https://parkinsonspathways.com/agent/trials/NCT07024173.md"
clinicaltrials_gov: "https://clinicaltrials.gov/study/NCT07024173"
ct_last_update_post_date: 2026-01-26
last_seen_at: "2026-05-12T07:05:05.185Z"
source: ClinicalTrials.gov (mirrored, no enrichment)
---
# A Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer

**Official Title:** A Multicenter, Open-label, Randomized Controlled Phase 3 Study of HRS-8080 Versus Treatment Chosen by Physicians in Locally Advanced and Metastatic Breast Cancer With Disease Progression After Previous Endocrine Therapy

**NCT ID:** [NCT07024173](https://clinicaltrials.gov/study/NCT07024173)

## Key Facts

- **Status:** RECRUITING
- **Phase:** PHASE3
- **Study Type:** INTERVENTIONAL
- **Target Enrollment:** 240
- **Lead Sponsor:** Shandong Suncadia Medicine Co., Ltd.
- **Conditions:** Locally Advanced Breast Cancer, Metastatic Breast Cancer
- **Start Date:** 2025-07-23
- **Completion Date:** 2027-12
- **CT.gov Last Update:** 2026-01-26

## 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.

## Eligibility

- **Minimum age:** 18 Years
- **Maximum age:** 75 Years
- **Sex:** FEMALE
- **Healthy Volunteers:** No

```
Inclusion Criteria:

1. Women aged 18 to 75 years old (including both values).
2. ECOG Physical Strength Status (PS) : 0 to 1 point.
3. Patients with locally advanced or metastatic breast cancer confirmed by histology.
4. Patients previously received 1-2 lines of endocrine therapy.
5. Expected survival \> 6 months.
6. The functional level of the organs must meet the requirements.
7. 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.

Exclusion Criteria:

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

## Arms

- **HRS-8080 Group** (EXPERIMENTAL)
- **Fulvestrant Group** (ACTIVE_COMPARATOR)
- **Exemestane in combination with Everolimus Group** (ACTIVE_COMPARATOR)
- **Exemestane or Anastrozole or Letrozole Group** (ACTIVE_COMPARATOR)

## Interventions

- **HRS-8080 Tablet** (DRUG) — HRS-8080 tablet orally administered.
- **Fulvestrant injection** (DRUG) — Fulvestrant injection.
- **Exemestane tablets** (DRUG) — Exemestane tablets orally administered.
- **Everolimus Tablets** (DRUG) — Everolimus tablets orally administered.
- **Anastrozole Tablets** (DRUG) — Anastrozole tablets orally administered.
- **Letrozole Tablets** (DRUG) — Letrozole tablets orally administered.

## Primary Outcomes

- **Progression free survival (PFS) evaluated by the blinded independent central review (BICR).** _(time frame: Approximately 2 years.)_

## Secondary Outcomes

- **Progression free survival (PFS) evaluated by investigators.** _(time frame: Approximately 2 years.)_
- **Overall response rate (ORR).** _(time frame: Approximately 2 years.)_
- **Clinical benefit rate (CBR).** _(time frame: Approximately 2 years.)_
- **Duration of response (DOR).** _(time frame: Approximately 2 years.)_
- **Overall survival (OS).** _(time frame: Approximately 3 years.)_
- **Adverse events (AEs).** _(time frame: Approximately 2 years.)_
- **Serious adverse events (SAEs).** _(time frame: Approximately 2 years.)_

## Locations (2)

- Sun Yat-sen University Cancer Center, Guangzhou, Guangdong, China — _RECRUITING_
- Hunan Cancer Hospital, Changsha, Hunan, China — _RECRUITING_

## Recent Field Changes (last 30 days)

- `status.overallStatus` — added _(2026-05-12)_
- `status.primaryCompletionDate` — added _(2026-05-12)_
- `status.completionDate` — added _(2026-05-12)_
- `status.lastUpdatePostDate` — added _(2026-05-12)_
- `design.phases` — added _(2026-05-12)_
- `design.enrollmentCount` — added _(2026-05-12)_
- `eligibility.criteria` — added _(2026-05-12)_
- `eligibility.minAge` — added _(2026-05-12)_
- `eligibility.maxAge` — added _(2026-05-12)_
- `eligibility.sex` — added _(2026-05-12)_
- `outcomes.primary` — added _(2026-05-12)_
- `outcomes.secondary` — added _(2026-05-12)_
- `armsInterventions.arms` — added _(2026-05-12)_
- `armsInterventions.interventions` — added _(2026-05-12)_
- `sponsor.lead` — added _(2026-05-12)_
- `results.hasResults` — added _(2026-05-12)_
- `locations.sun yat-sen university cancer center|guangzhou|guangdong|china` — added _(2026-05-12)_
- `locations.hunan cancer hospital|changsha|hunan|china` — added _(2026-05-12)_

---

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*Source data (authoritative): https://clinicaltrials.gov/study/NCT07024173*  
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