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

NCT ID: NCT06954961

Last Updated: 2025-05-02

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE3
• Total Enrollment: 640 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-15
• Study Completion Date: 2028-12-31

Brief Summary

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.

Conditions

Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

D-0502

Group Type: EXPERIMENTAL

D-0502

Intervention Type: DRUG

• Dosage form: Tablet
• Administration route: Oral, once a day

Fulvestrant

Group Type: ACTIVE_COMPARATOR

Fulvestrant

Intervention Type: DRUG

• Dosage form: Injection
• Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose

Interventions

D-0502

• Dosage form: Tablet
• Administration route: Oral, once a day

Intervention Type: DRUG

Fulvestrant

• Dosage form: Injection
• Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose

Intervention Type: DRUG

Eligibility Criteria

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;

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

InventisBio Co., Ltd

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Binghe Xu, MD

Role: PRINCIPAL_INVESTIGATOR

Cancer Hospital

Qingyuan Zhang, MD

Role: PRINCIPAL_INVESTIGATOR

Harbin

Locations

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, China

Site Status: RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, China

Site Status: RECRUITING

Countries

China

Central Contacts

Yuting Li

Role: CONTACT

yuting.li@inventisbio.com

8615821378026

Facility Contacts

Binghe Xu

Role: primary

xubinghe@medmail.com.cn

8613501028690

Qingyuan Zhang

Role: primary

sy86298276@163.com

13313612989

Other Identifiers

D0502-303

Identifier Type: -

Identifier Source: org_study_id