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New treatment option for Hormone Receptor-Positive Breast Cancer
Official title ctDNA-Guided De-Escalation of Adjuvant Chemotherapy With Dalpiciclib in HR-Positive/HER2-Negative Breast Cancer
ClinicalTrials.gov ID: NCT06970912
What this study is testing
What is Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy?
Dalpiciclib + Aromatase Inhibitor with ctDNA-Guided Therapy is an investigational medicine, given as an once-weekly pill taken by mouth, being studied as a potential treatment for hormone receptor-positive breast cancer.
Also referred to as Dalpiciclib/AI combination therapy, SHR6390 + aromatase inhibitor.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 2: a mid-size study of how well it works
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 75, women only
You may be able to join if
- Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal/perimenopausal;
- Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:
- ER-positive and/or PR-positive defined as: ≥10% of tumor cells showing positive staining;
- HER2-negative defined as: standard immunohistochemistry (IHC) result of 0/1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the...
- At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:
You likely can't join if
- HER2-positive breast cancer confirmed by current pathological diagnosis;
- Inflammatory breast cancer;
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer);
- Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy)...
See the full eligibility criteria
- Female breast cancer patients aged ≥18 years and ≤75 years, either postmenopausal or premenopausal/perimenopausal;
- Pathologically confirmed hormone receptor-positive (HR+), HER2-negative invasive breast cancer:
- ER-positive and/or PR-positive defined as: ≥10% of tumor cells showing positive staining;
- HER2-negative defined as: standard immunohistochemistry (IHC) result of 0/1+; or IHC 2+ with negative in situ hybridization (ISH) (confirmed by the central pathology laboratory);
- At least one evaluable lesion per RECIST 1.1, with clinical staging meeting:
- T1c-2N0M0 with high-risk factors (Grade 3, or Grade 2 with Ki67 ≥20%);
- T3N0M0;
- Any TN+M0;
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1;
- Willing to participate in the study and voluntarily sign informed consent;
- Agree to undergo ctDNA testing during treatment;
- Adequate organ and bone marrow function defined as:
- Absolute neutrophil count (ANC) ≥1,500/mm³ (1.5 × 10⁹/L) (without granulocyte colony-stimulating factor [G-CSF] treatment within 14 days);
- Platelet count (PLT) ≥100,000/mm³ (100 × 10⁹/L) (without corrective therapy within 7 days);
- Hemoglobin (Hb) ≥9 g/dL (90 g/L) (without corrective therapy within 7 days);
- Serum creatinine ≤1.5× upper limit of normal (ULN) or creatinine clearance ≥60 mL/min (without corrective therapy within 7 days);
- Total bilirubin (TBIL) ≤1.5×ULN (without corrective therapy within 7 days);
- Aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤1.5×ULN (without corrective therapy within 7 days);
- Cardiac function: left ventricular ejection fraction (LVEF) ≥55%; QTc interval corrected by Fridericia's formula (QTcF) \<470 msec on 12-lead ECG;
- Women of childbearing potential must have a negative serum pregnancy test within 7 days prior to randomization and agree to use non-hormonal contraception from informed consent signing until 2 months after the last...
- HER2-positive breast cancer confirmed by current pathological diagnosis;
- Inflammatory breast cancer;
- Stage IV (metastatic) breast cancer;
- Bilateral breast cancer;
- Prior history of breast cancer (including ductal carcinoma in situ or invasive breast cancer);
- Any prior antitumor therapy for the current breast cancer, including systemic therapies (endocrine, chemotherapy, immunotherapy, biological therapy) or local therapies (radiotherapy, vascular embolization, axillary...
- Diagnosis of any malignancy within 5 years prior to randomization, except cured cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin;
- History of severe pulmonary diseases (e.g., interstitial pneumonia);
- HIV infection, acquired immunodeficiency syndrome (AIDS), active hepatitis B (HBV DNA ≥500 IU/mL), hepatitis C (HCV antibody-positive with HCV RNA above the lower limit of detection), or co-infection with HBV and HCV;
- Within 6 months prior to randomization: myocardial infarction, severe/unstable angina, NYHA Class ≥II heart failure, ≥Grade 2 persistent arrhythmia (per NCI CTCAE v5.0), atrial fibrillation of any grade...
- Severe active infection within 4 weeks prior to randomization (requiring intravenous antibiotics, antifungals, or antivirals) or unexplained fever \>38.5°C during screening/before first dose;
- Known allergy to any component of the study drugs;
- Current participation in another treatment drug clinical study;
- Pregnancy or lactation;
- Refusal to comply with follow-up;
- Other severe physical/mental illnesses or laboratory abnormalities that may increase study risk, interfere with results, or render the patient unsuitable per investigator judgment.
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling female, 18 years to 75 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.