ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
This is not medical advice. AI-assisted translation — inaccuracies may occur. Always verify the original and consult your oncologist before taking any steps.
About the trial
* 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.
Original English text from ClinicalTrials.gov
Who can (and can't) join
✓ Qualifies
- •Kobiety w wieku 18-75 lat.
- •Wczesny rak piersi typu HR+ (hormonowrażliwy) i HER2- (bez nadekspresji białka HER2).
- •Rak piersi o podwyższonym ryzyku nawrotu (np. duży guz, zajęte węzły chłonne, agresywny typ).
- •Dobry ogólny stan zdrowia pozwalający na leczenie.
- •Zgoda na udział w badaniu i wykonanie dodatkowych badań krwi (ctDNA).
✗ Disqualifies
- •Kobiety w ciąży lub karmiące piersią.
- •Pacjentki, które wcześniej miały inne nowotwory (z pewnymi wyjątkami).
- •Pacjentki z zaawansowanym rakiem piersi lub rozsianym.
- •Pacjentki z poważnymi problemami z sercem, nerkami lub wątrobą.
- •Pacjentki, które niedawno przyjmowały określone leki przeciwnowotworowe.
Simplified criteria — AI translation
Trial details
- Minimum age
- 18 Years
- Maximum age
- 75 Years
- Last updated (source)
- July 13, 2026
- Sex
- Female only
Therapies / drugs in trial
Locations (1)
Peking University People's Hospital
Beijing, China
Trial contact
yuan peng, doctor
Contact information from ClinicalTrials.gov. Contact in English.
Share this trial
Data from ClinicalTrials.gov. AI-assisted translation, last sync: 7/1/2026.
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