OncoMatch/Clinical Trials/NCT06276868
Darsilide Combined With AI, Trastuzumab and Patuzumab in the Neoadjuvant Treatment of HR+/HER2+ Breast Cancer
Is NCT06276868 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies Dalcilib+letrozole+HP treatment group for breast cancer.
Treatment: Dalcilib+letrozole+HP treatment group — This study is intended to carry out a single arm, prospective, open clinical study, and use Darsilide combined with endocrine therapy, Trastuzumab and Patuzumab to treat early or locally advanced breast cancer of TPBC before surgery. It is intended to further explore the efficacy and safety of the new adjuvant treatment for TPBC patients with step-down therapy.
Check if I qualifyExtracted eligibility criteria
Treatments studied
Other
Cancer type
Breast Carcinoma
Biomarker criteria
Required: HER2 (ERBB2) positive
Required: ESR1 positive
Required: PR (PGR) positive
Disease stage
Required: Stage II, IIIA
Excluded: Stage IV
Performance status
ECOG 0–1(Restricted strenuous activity)
Demographics
Prior therapy
Cannot have received: anti-tumor therapy
Exception: excluding cured cervical cancer in situ, basal cell carcinoma, or squamous cell carcinoma
Previously received anti-tumor therapy or radiation therapy for any malignant tumor, excluding cured cervical cancer in situ, basal cell carcinoma, or squamous cell carcinoma
Lab requirements
Blood counts
ANC ≥1.5×10^9/L; PLT ≥100×10^9/L; Hb ≥90g/L
Kidney function
BUN and Cr ≤ 1.5 × ULN and creatinine clearance rate ≥ 50 mL/min
Liver function
TBIL ≤ 1.5 ULN; ALT and AST ≤ 1.5 ULN; Alkaline phosphatase ≤ 2.5 ULN
Cardiac function
LVEF ≥ 50%
The main organs function normally and meet the following standards: blood routine examination...biochemical examination...cardiac ultrasound and echocardiography: LVEF ≥ 50%
Structured fields extracted by AI. May contain errors — verify against the official protocol.
Frequently asked questions
Is NCT06276868 currently recruiting?
Yes, this trial is currently recruiting patients.
Can patients have received prior systemic therapy?
No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.
Does this trial require ERBB2?
Yes, ERBB2 positive is a required biomarker for enrollment.
Does this trial require ESR1?
Yes, ESR1 positive is a required biomarker for enrollment.
Does this trial require PGR?
Yes, PGR positive is a required biomarker for enrollment.
What disease stage is eligible?
Stage II or IIIA is required.
Is there an age limit?
Yes. Patients must be 70 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 qualify