Comparing dalpiciclib with AI to chemotherapy for early breast cancer treatment

A Phase II Randomized, Non-inferiority Study Comparing the Efficacy and Safety of Dalpiciclib Combined With AI With Neoadjuvant Chemotherapy in ER+ HER2- Postmenopausal Breast Cancer Patients

This study is testing whether a new treatment combining dalpiciclib with hormone therapy can work as well as standard chemotherapy for postmenopausal women with early breast cancer.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 144 (estimated)
• Ages: 18 Years to 75 Years
• Sex: Female
• Sponsor: Hebei Medical University Fourth Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Shijiazhuang, Hebei)
• Trial ID: NCT06107673 on ClinicalTrials.gov

What this trial studies

This multi-center, randomized, prospective phase II clinical trial evaluates the efficacy of dalpiciclib combined with aromatase inhibitors (AI) as neoadjuvant therapy for postmenopausal women with early breast cancer that is ER strong positive and HER2-negative. Participants will be randomly assigned to receive either the dalpiciclib plus AI regimen or standard chemotherapy. The study aims to demonstrate that the new treatment is at least as effective as chemotherapy while potentially offering a better safety profile. Treatment will continue for 24 weeks or until disease progression or intolerable side effects occur.

Who should consider this trial

Good fit: Ideal candidates are postmenopausal females diagnosed with ER strong positive, HER2-negative early breast cancer at clinical stage T1-3N1M0.

Not a fit: Patients with prior breast cancer treatment or significant cardiac diseases may not benefit from this study.

Why it matters

Potential benefit: If successful, this approach could provide a safer and equally effective alternative to chemotherapy for patients with early breast cancer.

How similar studies have performed: Other studies have shown promising results with similar neoadjuvant endocrine therapies, but this specific combination is being explored for the first time.

Eligibility criteria

Inclusion Criteria:

1. Sign the informed consent form to participate in the clinical research.
2. Confirmed postmenopausal females diagnosed with invasive breast cancer.
3. Clinical stage T1-3N1M0.
4. 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 for ER: ER immunohistochemistry test shows 50% or more tumor cells positive.
5. No prior breast cancer-related treatment.
6. No concurrent cardiac diseases, baseline left ventricular ejection fraction (LVEF) ≥ 50%, no significant cardiac diseases (≤ NYHA class I).
7. ECOG score of 0-1, meeting the indications and basic requirements for chemotherapy without major organ dysfunction.
8. 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.
9. 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) ≤ 2× ULN; Serum creatinine ≤ 1.5× ULN or creatinine clearance rate (Ccr) ≥ 60 ml/min.
10. 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.
11. Exhibits good compliance.

Exclusion Criteria:

1. 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.
2. 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.
3. Patients with bilateral breast cancer or inflammatory breast cancer.
4. Patients with metastatic (stage IV) breast cancer at initial diagnosis.
5. Patients with a history of congestive heart failure, unstable angina, arrhythmias, or myocardial infarction.
6. Current diagnosis of acute lung conditions, interstitial lung disease, pulmonary fibrosis, acute pulmonary disease, etc.
7. 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 DNA titer should be \< 1×10\^3 IU/ml for eligibility.
8. 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 antiviral therapy for liver and bile diseases).
9. Other invasive malignancies (including second primary breast cancer) that may interfere with the evaluation of study endpoints and compliance with the protocol.
10. 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).
11. Patients who have undergone major surgery within 4 weeks prior or have significant unresolved medical conditions.
12. Patients with non-measurable tumors during treatment.
13. Any other condition that the investigator deems unsuitable for the participation of the subject in the study.

Where this trial is running

Shijiazhuang, Hebei

• The Fourth Hospital of Hebei Medical University — Shijiazhuang, Hebei, China (Recruiting)

Study contacts

• Study coordinator: lina zhang

Conditions Breast Cancer; HER2- ER+; Neoadjuvant therapy; Dalpiciclib