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Compares treatment options for Breast Cancer
Official title Dalpiciclib Plus AI (Neoadjuvant Endocrine Therapy) Compared With Neoadjuvant Chemotherapy in Early Breast Cancer （EBC）
ClinicalTrials.gov ID: NCT06107673
What this study is testing
What is Dalpiciclib?
Dalpiciclib is an investigational medicine, given as an once-daily, being studied as a potential treatment for breast cancer.
Also referred to as SHR6390.
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 study is a multi-center, randomized, prospective phase II clinical trial aimed at exploring and evaluating the efficacy of dalpiciclib combined with AI in neoadjuvant treatment for ER strong positive（ER≥50%），HER2-negative, Ki-67≤20%,T1-3N1M0 postmenopausal breast cancer. The primary objectives are to demonstrate non-inferiority in efficacy compared to chemotherapy and to assess its superior safety profile.
- 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
- Sign the informed consent form to participate in the clinical research.
- Confirmed postmenopausal females diagnosed with invasive breast cancer.
- Clinical stage T1-3N1M0.
- Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (++)...
- No prior breast cancer-related treatment.
You likely can't join if
- Pregnant or lactating women, and women of childbearing age who have a positive pregnancy test at baseline and do not agree to use effective...
- Patients with a known history of severe allergic reactions to any investigational drug components (NCI-CTCAE Grade \> 3) or with any clearly...
- Patients with bilateral breast cancer or inflammatory breast cancer.
- Patients with metastatic (stage IV) breast cancer at initial diagnosis.
- Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction.
- Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc.
See the full eligibility criteria
- Sign the informed consent form to participate in the clinical research.
- Confirmed postmenopausal females diagnosed with invasive breast cancer.
- Clinical stage T1-3N1M0.
- Pathological examination confirmed: Strong positive for ER, negative for HER2. HER2 negative: Immunohistochemistry (IHC) suggests HER2 (-, +) or (++) but in situ hybridization (ISH) indicates negative. Strong positive...
- No prior breast cancer-related treatment.
- No concurrent cardiac diseases, baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I).
- ECOG score of 0-1, meeting the indications and basic requirements for chemotherapy without major organ dysfunction.
- Within 1 week prior to enrollment, routine blood tests are essentially normal: Absolute neutrophil count (NEUT#) ≥ 1.5×10\^9 /L; White blood cell count (WBC) ≥ 3.0×10\^9 /L; Platelets ≥ 90×10\^9 /L; Hemoglobin ≥ 90 g/L.
- Within 1 week prior to enrollment, liver and kidney function tests are essentially normal: Total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN); Alanine aminotransferase and aspartate aminotransferase (ALT/AST) ≤...
- For women of childbearing age, negative serum or urine pregnancy test results before participation; premenopausal women during the study period should use medically acceptable methods of contraception.
- Exhibits good compliance.
- Pregnant or lactating women, and women of childbearing age who have a positive pregnancy test at baseline and do not agree to use effective contraception during the study.
- Patients with a known history of severe allergic reactions to any investigational drug components (NCI-CTCAE Grade \> 3) or with any clearly documented drug allergy.
- Patients with bilateral breast cancer or inflammatory breast cancer.
- Patients with metastatic (stage IV) breast cancer at initial diagnosis.
- Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction.
- Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc.
- Current diagnosis of severe liver-related diseases such as acute hepatitis, fulminant hepatitis, coagulation factor synthesis disorders. If HBV surface antigen or HBV core antibody are positive, the peripheral blood HBV...
- Any other serious medical condition or comorbidity that may interfere with participation in the study or may significantly affect the safety of the subject (e.g., active or uncontrolled infections, active or requiring...
- Other invasive malignancies (including second primary breast cancer) that may interfere with the evaluation of study endpoints and compliance with the protocol.
- Patients with a history of prior treatment with chemotherapy, endocrine therapy, or anti-HER2 biologic therapy for breast cancer (excluding diagnostic biopsy for primary breast cancer).
- Patients who have undergone major surgery within 4 weeks prior or have significant unresolved medical conditions.
- Patients with non-measurable tumors during treatment.
- Any other condition that the investigator deems unsuitable for the participation of the subject in the study.
The study team makes the final eligibility decision.
Where it's taking place
- Shijiazhuang, Hebei, 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 Shijiazhuang, Hebei, 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.