🇮🇪Ireland
16°C Partly Cloudy · Dublin
Live Updates
--:--:-- IST
Writer Login
Latest
Clinical Trials in China / NCT06954961
Recruiting Phase 3

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

NCT06954961 · tracked via the Priya Life Science China tracker
Sponsor
InventisBio Co., Ltd
Phase
Phase 3
Started
2022-09-15
Last updated
2026-03-31

Condition(s) studied

Breast Cancer

Investigational drug(s) / intervention(s)

D-0502Fulvestrant →

D-0502: * Dosage form: Tablet * Administration route: Oral, once a day

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

Study 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.

Eligibility

Sex
FEMALE
Min age
18 Years
Max age
75 Years
Healthy volunteers
No
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;

Primary outcome measure(s)

Trial sites (2)

FacilityCityRegionStatus
Cancer Hospital Chinese Academy of Medical Science Beijing Beijing Municipality Recruiting
Harbin Medical University Cancer Hospital Harbin Heilongjiang Recruiting

More InventisBio Co., Ltd trials in China

Other trials for the same condition

Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06954961 on ClinicalTrials.gov ↗ ← All trials in China