breast cancer
Conditions
Interventions
Combined treatment group:Radiotherapy plus Dalpiciclib
Sequential treatment group:Radiotherapy first, followed by dalpiciclib treatment after radiotherapy is completed.
Sponsors
Shanxi Cancer Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 1. Age 18–75 years (inclusive). 2. Histologically confirmed hormone-receptor-positive (HR+)/HER2-negative breast carcinoma, defined as ER positivity and/or PR positivity in = 10 % of tumour cells by central pathology review. 3. Clinical stage at diagnosis: - Stage IIA: T1N1M0 - Stage IIB: T2N1M0 - Stage III: T3–T4N1M0, any N2, or any N3 4. Ipsilateral axillary-lymph-node involvement documented pathologically: a. >= 4 positive nodes, or b. 1–3 positive nodes plus at least one high-risk feature: i. Post-operative primary tumour >= 5 cm ii. Histological grade III or above iii. vascular invasion iv. Residual invasive disease in breast or ipsilateral axillary lymph nodes after neoadjuvant therapy v. Ki-67 >= 30 % 5. Planned to receive adiotherapy. 6. Prior chemotherapy before radiotherapy is permitted. 7. Adequate organ function: 1) Haematological function ANC >= 1.5 × 10?/L (no G-CSF within 14 days) Platelets >= 100 × 10?/L (no transfusion within 7 days) Hb >= 100 g/L (no transfusion within 7 days) 2) Hepatic & Renal function Total bilirubin = 50 mL/min (Cockcroft-Gault) 3)Cardiac function Corrected QT interval <= 480 ms on 12-lead ECG 8. Signed informed consent, willing to comply with study procedures and follow-up.
Exclusion criteria
Exclusion criteria: 1. Recurrent or metastatic breast cancer. 2. HER2-positive by immunohistochemistry (IHC 3+) or ISH gene amplification (IHC 2+/ISH+). 3. Evidence of severe or uncontrolled systemic disease, including but not limited to: - Uncontrolled hypertension - Active bleeding diathesis - Active infection (e.g., hepatitis B, hepatitis C, HIV) - Significant bone-marrow reserve deficiency or major hepatic/renal impairment 4. History of any malignancy within 5 years prior to enrollment except adequately treated cervical carcinoma in situ, basal-cell carcinoma, or squamous-cell carcinoma of the skin. 5. Prior history of interstitial pneumonitis or other severe pneumonitis. 6. Persistent CTCAE grade = 3 toxicity(s) attributed to prior anti-cancer therapy at the time of study treatment initiation. 7. Prior cardiac conditions, including: (1) Clinically significant or medication-requiring arrhythmias; (2) Myocardial infarction; (3) Heart failure; (4) Any other cardiac disorder deemed by the investigator to render the patient unsuitable for trial participation. 8. Significant commodities, including psychiatric disorders that, in the opinion of the investigator or sponsor, could compromise the patient’s ability to participate in the study. 9. History of immunodeficiency (e.g., HIV-positive status), acquired or congenital immune-deficiency disorders, prior solid-organ or allogeneic bone-marrow transplantation; history of interstitial lung disease or non-infectious pneumonitis. 10. Patients considered by the investigator to be otherwise ineligible for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of any adverse event >= Grade 3; | — |
Secondary
| Measure | Time frame |
|---|---|
| /Proportion of radiotherapy interruptions;Disease free survival;patient-reported outcome; | — |
Countries
China
Contacts
Public ContactYu Wang
Shanxi Cancer Hospital
Outcome results
None listed