Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in HR+/ HER2- Early Breast Cancer
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Dalpiciclib, Endocrine therapy.
- Who it may be relevant to
- Registry conditions: Early Breast Cancer. Basic parameters: 18 years — 75 years · Female.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Efficacy and Safety of Dalpiciclib With Endocrine Therapy as Adjuvant Treatment in Patients With Hormone Receptor-positive, HER2-negative Early Breast Cancer
Overview
The investigator conduct a phase II multi-center, open-label trial to evaluate efficacy and safety of dalpiciclib with endocrine therapy as adjuvant treatment in patients with medium /high risk hormone receptor-positive, HER2-negative Early Breast Cancer.
Interventions
- Drug Dalpiciclib
CDK4/6 inhibitor dalpiciclib, 100mg orally qd - Drug Endocrine therapy
Fulvestrant/AI
Primary outcome measures
- invasive Disease-free Survival (iDFS) [Time frame: From enrollment until time of events up to 3 years]
Secondary outcome measures (2)
- Disease-free Survival (DFS) [Time frame: From enrollment until time of events up to 3 years]
- AEs and SAEs [Time frame: From the first administration to one months after the last drug administration，up to one month]
Eligibility criteria
Inclusion criteria
- Patient is ≥ 18 years-old
- Patient is female with known menopausal status (postmenopausal or premenopausal/perimenopause)
- Patient with histologically confirmed HR+/HER2- early breast cancer (immunohistochemical ER and/or PR≥10%)
- Histologically confirmed invasive breast cancer with anatomic stages of IIA-IIIC stage (T2-4N0-3M0), of which stage IIA only included T1N1M0
- Patients with or without neoadjuvant or adjuvant chemotherapy/ radiotherapy were eligible for inclusion
- From operation to enrollment should not exceed 12 months
- Patient has an Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1
Exclusion criteria
- metastatic disease (Stage IV) or inflammatory breast cancer
- Previous or current history of malignant neoplasms, except for curatively treated:Basal and squamous cell carcinoma of the skin,Carcinoma in situ of the cervix.
- Clinically relevant cardiovascular disease:Known history of uncontrolled or symptomatic angina, clinically significant arrhythmias, congestive heart failure, transmural myocardial infarction, uncontrolled hypertension ≥180/110);
- A history of allergy to the drugs in this study；
- Unable or unwilling to swallow tablets
- History of gastrointestinal disease with diarrhea as the major symptom.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- N/A
- Model
- Single group
- Masking
- Open label
- Primary purpose
- Treatment
Study locations
China · 1 center
- The First Affiliated Hospital of Nanjing Medical University — Nanjing
Identifiers
NCT: NCT06341894 · OBU-II-BC-126