OncoMatch/Clinical Trials/NCT06970912
ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
Is NCT06970912 recruiting? Yes, currently enrolling (May 2026). This Phase 2 trial studies multiple treatments including Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy and Taxane-Based Neoadjuvant Chemotherapy for hormone receptor-positive breast cancer.
Treatment: Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy · Taxane-Based Neoadjuvant Chemotherapy — * This is a Phase II, multicenter, randomized clinical trial evaluating a ctDNA-guided approach to de-escalate adjuvant chemotherapy in patients with hormone receptor (HR)-positive, HER2-negative early-stage breast cancer. The study aims to determine if combining the CDK4/6 inhibitor Dalpiciclib with endocrine therapy can reduce the need for chemotherapy while maintaining clinical benefits. * Key Details ： 1. Participants: 393 women (aged 18-75) with early-stage HR+/HER2- breast cancer at high risk of recurrence (e.g., tumor size ≥2 cm, lymph node involvement, or high-grade tumors). 2. Design: Patients are randomized 1:4 to two groups: Group A (Chemotherapy) : Receives 4 cycles of taxane-based chemotherapy before surgery. Group B (Experimental) : Receives Dalpiciclib + aromatase inhibitor (AI) for 4 cycles pre-surgery. Post-surgery, treatment is adjusted based on ctDNA results. 3. Primary Goals ： Assess ctDNA clearance rate (conversion from detectable to undetectable ctDNA) after neoadjuvant therapy in Group B. Evaluate 3-year event-free survival (EFS) in Group B (e.g., freedom from cancer recurrence, progression, or death). Secondary Goals ： Safety of Dalpiciclib + endocrine therapy. Tumor response rates (e.g., complete cell cycle arrest, pathological remission). Correlation between ctDNA clearance and long-term outcomes. * Why This Matters ： Current guidelines recommend chemotherapy for high-risk HR+ breast cancer, but it often causes significant side effects. This study explores a personalized approach using ctDNA-a blood-based biomarker-to identify patients who may safely avoid chemotherapy without compromising survival. If successful, it could shift clinical practice toward less toxic, targeted therapies for eligible patients.
Check if I qualifyExtracted eligibility criteria
Cancer type
Breast Carcinoma
Biomarker criteria
Required: ESR1 overexpression (≥10% of tumor cells showing positive staining)
ER-positive and/or PR-positive defined as: ≥10% of tumor cells showing positive staining
Required: PR (PGR) overexpression (≥10% of tumor cells showing positive staining)
ER-positive and/or PR-positive defined as: ≥10% of tumor cells showing positive staining
Required: HER2 (ERBB2) wild-type (IHC 0/1+; or IHC 2+ with negative ISH)
HER2-negative defined as: standard immunohistochemistry (IHC) result of 0/1+; or IHC 2+ with negative in situ hybridization (ISH)
Disease stage
Required: Stage T1C-3N0M0, ANY TN+M0
Excluded: Stage IV
clinical staging meeting: 1. T1c-3N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%); 2. Any TN+M0
Performance status
ECOG 0–1(Restricted strenuous activity)
Prior therapy
Cannot have received: endocrine therapy
Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy)
Cannot have received: chemotherapy
Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy)
Cannot have received: immunotherapy
Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy)
Cannot have received: biological therapy
Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy)
Cannot have received: radiation therapy
Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy)
Cannot have received: vascular embolization
Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy)
Cannot have received: axillary lymph node biopsy
Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary lymph node biopsy)
Lab requirements
Blood counts
ANC ≥1,500/mm³ (without G-CSF within 14 days); PLT ≥100,000/mm³ (without corrective therapy within 7 days); Hb ≥9 g/dL (without corrective therapy within 7 days)
Kidney function
Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (without corrective therapy within 7 days)
Liver function
Total bilirubin ≤1.5×ULN; AST/SGOT and ALT/SGPT ≤1.5×ULN (without corrective therapy within 7 days)
Cardiac function
LVEF ≥55%; QTcF <470 msec on 12-lead ECG
Adequate organ and bone marrow function defined as: ANC ≥1,500/mm³ (without G-CSF within 14 days); PLT ≥100,000/mm³ (without corrective therapy within 7 days); Hb ≥9 g/dL (without corrective therapy within 7 days); Serum creatinine ≤1.5×ULN or creatinine clearance ≥60 mL/min (without corrective therapy within 7 days); Total bilirubin ≤1.5×ULN (without corrective therapy within 7 days); AST/SGOT and ALT/SGPT ≤1.5×ULN (without corrective therapy within 7 days); Cardiac function: LVEF ≥55%; QTcF <470 msec on 12-lead ECG
Structured fields extracted by AI. May contain errors — verify against the official protocol.
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