OncoMatch/Clinical Trials/NCT06954961
A Study to Evaluate D-0502 in Subjects With ER+ Her2- Locally Advanced or Metastatic Breast Cancer
Is NCT06954961 recruiting? Yes, currently enrolling (Jun 2026). This Phase 3 trial studies multiple treatments including D-0502 and Fulvestrant for breast cancer.
Treatment: D-0502 · Fulvestrant — 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.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Endocrine / hormonal
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) negative
Required: ESR1 positive
Demographics
Prior therapy
Must have received: endocrine therapy — adjuvant or metastatic
disease recurrence during or after adjuvant endocrine therapy, or whose disease has progressed after 1-2 lines of systemic endocrine therapy
Cannot have received: systemic chemotherapy
Exception: no more than 2 prior systemic chemotherapy
Subjects with locally advanced or metastatic breast cancer who have previously received more than 2 prior systemic chemotherapy
Cannot have received: selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA) (fulvestrant, GDC-9545, AZD9833, SAR-439859, Zn-c5, LX-039, HS234)
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.
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06954961 currently recruiting?
Yes, this trial is currently recruiting patients.
Are there prior therapy exclusions?
Yes. Prior systemic chemotherapy, selective estrogen receptor degrader (SERD)/selective estrogen receptor covalent antagonist (SERCA) disqualifies patients from enrollment.
Does this trial require ERBB2?
Yes, ERBB2 negative is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Is there an age limit?
Yes. Patients must be 75 years or younger.
Is this trial open to male patients?
No. This trial enrolls female patients only.
Could you qualify for this trial?
Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.
Check if I qualifyRelated pages