Neoadjuvant Dalpiciclib + AI → SHR-A1811 for HR+/HER2-Low Breast Cancer

Starting soon · Phase 2

Conditions studied: Breast Cancer, HR Positive/HER2 Low Breast Cancer

In brief

This is a phase II, single-arm, prospective exploratory study to evaluate the efficacy and safety of neoadjuvant dalpiciclib (a CDK4/6 inhibitor) plus an aromatase inhibitor (AI) followed by SHR-A1811 (an anti-HER2 antibody-drug conjugate) in patients with intermediate-to-high risk, hormone receptor-positive (HR+), HER2-low breast cancer. Patients will receive dalpiciclib (125 mg orally once daily, days 1-21, every 4 weeks) plus AI (anastrozole 1 mg, letrozole 2.5 mg, or exemestane 25 mg once daily) for 4 cycles, followed by SHR-A1811 (4.8 mg/kg intravenously every 3 weeks) for 4 cycles. The primary endpoint is objective response rate (ORR) per RECIST 1.1. Secondary endpoints include pathological complete response (pCR), breast-conserving surgery rate, event-free survival (EFS), change in Ki-67 index, and safety. A total of 20 participants will be enrolled.

Key facts

Study ID

NCT07618923

Run by

Tang-Du Hospital

People needed

20

Starts

2026-06-01

Expected to finish

2029-01-01

Last updated by the study team

2026-06-11

Who can join

Age: 18 and older, up to 70. Sex: female. Healthy volunteers: not accepted.

You may qualify if…

• Age ≥18 and ≤70 years
• Histologically confirmed invasive breast cancer, HR+ (ER ≥1% and/or PR ≥1%) and HER2-low (IHC 1+ or IHC 2+/ISH-)
• No prior systemic anti-tumor therapy for breast cancer
• Stage II-III (T1cN1-2M0, T2-4N0-2M0) per AJCC 8th edition
• At least one of the following intermediate-to-high risk factors:
• Axillary lymph node involvement ≥1
• Tumor size≥2 cm
• Grade 3 tumor
• Ki-67 ≥20%
• At least one measurable lesion per RECIST 1.1
• ECOG PS 0-1
• Adequate organ function (ANC ≥1.5×10⁹/L, platelets ≥100×10⁹/L, Hb ≥90 g/L, TBIL ≤1.5×ULN, ALT/AST ≤2.5×ULN, Cr ≤1.5×ULN or CrCl ≥60 mL/min, LVEF ≥50%, QTcF ≤470 ms in females, DLCO ≥50% predicted
• Negative pregnancy test (for women of childbearing potential) and agreement to use adequate contraception during and for 6 months after treatment
• Willing and able to provide informed consent and comply with study procedures

You may not qualify if…

• Non-pathologically confirmed breast cancer
• Bilateral, inflammatory, or occult breast cancer
• Prior anticancer therapy (chemotherapy, radiotherapy, targeted therapy, endocrine therapy, etc.)
• Concurrent use of other anticancer treatments
• Other malignancy within 5 years (except cured basal cell carcinoma or cervical carcinoma in situ)
• Participation in another interventional clinical trial within 4 weeks prior to first dose
• Use of immunosuppressive agents or systemic corticosteroids (>10 mg/day prednisone or equivalent) within 2 weeks prior to first dose
• Live or attenuated vaccine within 4 weeks prior to first dose
• Major surgery unrelated to breast cancer within 4 weeks prior to first dose
• Active or history of autoimmune disease requiring systemic treatment
• Known immunodeficiency (e.g., HIV positivity) or history of organ transplantation
• Uncontrolled or significant cardiovascular disease (e.g., NYHA class III/IV heart failure, myocardial infarction, unstable angina, arrhythmia requiring treatment, QTcF >470 ms, uncontrolled hypertension)
• Known or suspected interstitial lung disease (ILD) or significant pre-existing pulmonary disease
• Active hepatitis B (HBsAg positive and HBV DNA ≥500 IU/mL) or hepatitis C (HCV RNA above ULN), cirrhosis, or uncontrolled severe infection
• Known bleeding or thrombotic tendency
• Allergy or contraindication to any study drug or excipient
• Pregnancy, breastfeeding, or positive pregnancy test at baseline
• Any concurrent condition that may compromise patient safety or study compliance (e.g., uncontrolled hypertension, severe diabetes, active infection)
• History of neurological or psychiatric disorders (e.g., epilepsy, dementia) or any condition deemed unsuitable by the investigator.

Full record on ClinicalTrials.gov

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