Clinical trial NCT06954961: A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
Official title: 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
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: PHASE3
Conditions: Breast Cancer
Lead sponsor: InventisBio Co., Ltd
Sponsor class: INDUSTRY
First posted: 2025-05-02
Enrollment: 640
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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;

Primary outcomes:
measure: Progression free survival (PFS) assessed by Independent Review Committee (IRC)
timeFrame: From enrollment to the end of treatment, up to 2 years
Secondary outcomes:
measure: Progression free survival (PFS) -assessed by investigators
timeFrame: From enrollment to the end of treatment, up to 2 years
measure: Objective response rate (ORR) -assessed by IRC and investigators
timeFrame: From enrollment to the end of treatment, up to 2 years
measure: Clinical benefit rate (CBR) -assessed by IRC and investigators
timeFrame: From enrollment to the end of treatment, up to 2 years
measure: Disease control rate (DCR)-assessed by IRC and investigators
timeFrame: From enrollment to the end of treatment, up to 2 years
measure: Clearance (Cl) of D-0502
timeFrame: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
measure: Overall Survival (OS)
timeFrame: From end of treatment to end of study, about 2 years
measure: Number of participants with adverse events/serious adverse events and abnormal laboratory test results
timeFrame: From enrollment to 30 days after last dose
measure: Volume of distribution (Vd) of D-0502
timeFrame: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)
Other outcomes:
Locations:
city: Beijing
country: China
facility: Cancer Hospital Chinese Academy of Medical Science
state: Beijing
city: Harbin
country: China
facility: Harbin Medical University Cancer Hospital
state: Heilongjiang
Study officials:
affiliation: Cancer Hospital
name: Binghe Xu, MD
role: PRINCIPAL_INVESTIGATOR
affiliation: Harbin
name: Qingyuan Zhang, MD
role: PRINCIPAL_INVESTIGATOR
References: