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

NCT06954961 | Recruiting Phase 3 FDA Drug

• 1 other identifier: D0502-303
• Study Type: interventional
• Target: 640
• Locations: 1 country
• Sites: 2

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

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS) assessed by Independent Review Committee (IRC)

  From enrollment to the end of treatment, up to 2 years

Secondary Outcomes (8)

• 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)

Study Arms (2)

D-0502

EXPERIMENTAL

Drug: D-0502

Fulvestrant

ACTIVE COMPARATOR

Drug: Fulvestrant

Interventions

D-0502 DRUG

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

D-0502

Fulvestrant DRUG

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

Fulvestrant

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;

You may not qualify if:

• 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;

Sponsors & Collaborators

• InventisBio Co., Ltd: lead

Study Sites (2)

Cancer Hospital Chinese Academy of Medical Science

Beijing, Beijing Municipality, 100021, China

RECRUITING

Harbin Medical University Cancer Hospital

Harbin, Heilongjiang, 150081, China

RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Fulvestrant

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

Study Officials

• Binghe Xu, MD

  Cancer Hospital

  PRINCIPAL INVESTIGATOR

• Qingyuan Zhang, MD

  Harbin

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yuting Li

CONTACT

8615821378026; yuting.li@inventisbio.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: December 20, 2024
• First Posted: May 2, 2025
• Study Start: September 15, 2022
• Primary Completion (Estimated): November 30, 2026
• Study Completion (Estimated): December 31, 2028
• Last Updated: March 31, 2026

Record last verified: 2026-03

Locations

CN (2)