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

ConditionsLocally Advanced Breast CancerMetastatic Breast Cancer
Trial statusRecruiting
Trial phasePhase 3
Trial typeInterventional
Biological sexFemale
Age18-75
SponsorShandong Suncadia Medicine Co., Ltd.

About this trial

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 criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial design

Design model

Parallel

Treatments tested in this trial

  • 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.

Treatment groups

240 Participants
are divided into 4 treatment groups
Group A: HRS-8080 GroupExperimental treatment 1 intervention
Group B: Fulvestrant GroupActive comparator 1 intervention
Group C: Exemestane in combination with Everolimus GroupActive comparator 2 interventions
Group D: Exemestane or Anastrozole or Letrozole GroupActive comparator 3 interventions

Trial outcomes

Primary outcomes

1

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

Time frame
Approximately 2 years.

Secondary outcomes

1

Progression free survival (PFS) evaluated by investigators.

Time frame
Approximately 2 years.
2

Overall response rate (ORR).

Time frame
Approximately 2 years.
3

Clinical benefit rate (CBR).

Time frame
Approximately 2 years.
4

Duration of response (DOR).

Time frame
Approximately 2 years.

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Shandong Suncadia Medicine Co., Ltd.

Lead sponsor

Source ClinicalTrials.gov
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