NCT06954961 A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
| NCT ID | NCT06954961 |
| Status | Recruiting |
| Phase | Phase 3 |
| Sponsor | InventisBio Co., Ltd |
| Condition | Breast Cancer |
| Study Type | INTERVENTIONAL |
| Enrollment | 640 participants |
| Start Date | 2022-09-15 |
| Primary Completion | 2026-11-30 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
Phase 3 trials are large pivotal studies comparing the treatment to current standard of care or placebo. Your participation directly contributes to the evidence needed for regulatory approval.
This trial targets 640 participants in total. It began in 2022-09-15 with a primary completion date of 2026-11-30.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
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;
Contact & Investigator
Binghe Xu, MD
PRINCIPAL INVESTIGATOR
Cancer Hospital
Frequently Asked Questions
Who can join the NCT06954961 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 75 Years, studying Breast Cancer. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
What phase is the NCT06954961 trial and what does that mean for participants?
Phase 3 trials are large-scale studies comparing the new treatment to existing standards of care or a placebo. They provide the evidence needed for regulatory approval. This trial targets 640 participants.
Is NCT06954961 currently recruiting?
Yes, NCT06954961 is actively recruiting participants. Contact the research team at yuting.li@inventisbio.com for enrollment information.
Where is the NCT06954961 trial being conducted?
This trial is being conducted at Beijing, China, Harbin, China.
Who is sponsoring the NCT06954961 clinical trial?
NCT06954961 is sponsored by InventisBio Co., Ltd. The principal investigator is Binghe Xu, MD at Cancer Hospital. The trial plans to enroll 640 participants.
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