Recruiting NCT06954961
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: D-0502, Fulvestrant.
- Who it may be relevant to
- Registry conditions: Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Unsure about the terms? Read our patient guide →
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
Overview
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.
Interventions
- Drug D-0502
* Dosage form: Tablet * Administration route: Oral, once a day - Drug Fulvestrant
* Dosage form: Injection * Administration route: Intramuscular injection, once a month, and another dose administered two weeks after the first dose
Primary outcome measures
- Progression free survival (PFS) assessed by Independent Review Committee (IRC) [Time frame: From enrollment to the end of treatment, up to 2 years]
Secondary outcome measures (8)
- Progression free survival (PFS) -assessed by investigators [Time frame: From enrollment to the end of treatment, up to 2 years]
- Objective response rate (ORR) -assessed by IRC and investigators [Time frame: From enrollment to the end of treatment, up to 2 years]
- Clinical benefit rate (CBR) -assessed by IRC and investigators [Time frame: From enrollment to the end of treatment, up to 2 years]
- Disease control rate (DCR)-assessed by IRC and investigators [Time frame: From enrollment to the end of treatment, up to 2 years]
- Clearance (Cl) of D-0502 [Time frame: 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) [Time frame: 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 [Time frame: From enrollment to 30 days after last dose]
- Volume of distribution (Vd) of D-0502 [Time frame: on Cycle 1 Day 1, Cycle 1 Day 15, Cycle 2 Day 1 and Cycle 3 Day 1 (each cycle is 28 days)]
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;
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 2 centers
- Cancer Hospital Chinese Academy of Medical Science — Beijing
- Harbin Medical University Cancer Hospital — Harbin
Identifiers
NCT: NCT06954961 · D0502-303