A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer

A Randomized, Parallel-controlled, Open-label, Multicenter Phase III Clinical Study to Compare the Efficacy and Safety of D-0502 With Fulvestrant in Patients With Previously Treated ER-positive, HER2-negative Locally Advanced or Metastatic Breast Cancer

This is a randomized, parallel-controlled, open-label, multicenter clinical study to assess the efficacy and safety of D-0502 in the treatment of subjects with ER-positive, HER2-negative locally advanced or metastatic breast cancer with fulvestrant injection as a control drug.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: D-0502; Drug: Fulvestrant

• Study Type: Interventional
• Enrollment (Estimated): 640
• Phase: Phase 3

Contacts and Locations

• Study Contact: Name: Yuting Li; Phone Number: 8615821378026; Email: yuting.li@inventisbio.com

Study Locations

• China
  • Beijing Municipality
    • Beijing, Beijing Municipality, China, 100021
      • Recruiting
      • Cancer Hospital Chinese Academy of Medical Science
      • Contact: Binghe Xu; Phone Number: 8613501028690; Email: xubinghe@medmail.com.cn
  • Heilongjiang
    • Harbin, Heilongjiang, China, 150081
      • Recruiting
      • Harbin Medical University Cancer Hospital
      • Contact: Qingyuan Zhang; Phone Number: 13313612989; Email: sy86298276@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

• Subjects pathologically confirmed with ER-positive, HER2-negative breast cancer;
• Subjects with locally advanced (unresectable) or metastatic breast cancer who have disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy;
• Presence of at least 1 measurable lesion that can be measured by CT or MRI based on RECIST V1.1 criteria; in the absence of measurable lesions, subjects with evaluable bone lesions [osteolytic or mixed (osteolytic + osteogenic) bone lesions] are also acceptable. Lesions that have been previously treated with radiotherapy or other local therapy can be regarded as measurable lesions only if there is disease progression as confirmed by imaging examination;
• Expected survival time ≥ 12 weeks;

Exclusion Criteria:

• Subjects with unstable or symptomatic or progressive central nervous system (CNS) metastases. Subjects with a history of brain metastases who are clinically stable and have no CNS disease progression confirmed by brain MRI or CT (if MRI is not appropriate) can be enrolled (MRI or CT examination must be conducted at least 4 weeks after the last brain radiotherapy);
• Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy;
• Subjects are unsuitable for endocrine therapy judged by the investigator, including uncontrolled pleural effusion, ascites or pericardial effusion;
• Subjects with concomitant medical conditions that the investigator believes may increase the risk of toxicity, such as serious cardiovascular, respiratory or neurological diseases;
• Prior treatment with a selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA), such as fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn -c5, LX-039, HS234, etc.;
• Pregnant or lactating females;

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Fulvestrant	Drug: Fulvestrant; Dosage form: Injection; Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose
Experimental: D-0502	Drug: D-0502; Dosage form: Tablet; Administration route: Oral, once a day

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS) assessed by Independent Review Committee (IRC)	From enrollment to the end of treatment, up to 2 years

Secondary Outcome Measures

Outcome Measure	Time Frame
Progression free survival (PFS) -assessed by investigators	From enrollment to the end of treatment, up to 2 years
Objective response rate (ORR) -assessed by IRC and investigators	From enrollment to the end of treatment, up to 2 years
Clinical benefit rate (CBR) -assessed by IRC and investigators	From enrollment to the end of treatment, up to 2 years
Disease control rate (DCR)-assessed by IRC and investigators	From enrollment to the end of treatment, up to 2 years
Clearance (Cl) of D-0502	on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
Overall Survival (OS)	From end of treatment to end of study, about 2 years
Number of participants with adverse events/serious adverse events and abnormal laboratory test results	From enrollment to 30 days after last dose
Volume of distribution (Vd) of D-0502	on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)

Collaborators and Investigators

• Sponsor: InventisBio Co., Ltd
• Investigators: Principal Investigator: Binghe Xu, MD, Cancer Hospital; Principal Investigator: Qingyuan Zhang, MD, Harbin

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2028

Study Registration Dates

• First Submitted: December 20, 2024
• First Submitted That Met QC Criteria: April 28, 2025
• First Posted (Actual): May 2, 2025

Study Record Updates

• Last Update Posted (Actual): March 31, 2026
• Last Update Submitted That Met QC Criteria: March 25, 2026
• Last Verified: March 1, 2026

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Neoplasms by Site; Neoplasms; Skin Diseases; Breast Diseases; Skin and Connective Tissue Diseases; Breast Neoplasms; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Polycyclic Compounds; Steroids; Fused-Ring Compounds; Estradiol; Estrenes; Estranes; Estradiol Congeners; Gonadal Steroid Hormones; Gonadal Hormones; Fulvestrant
• Other Study ID Numbers: D0502-303

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No