Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer (NCT07706933) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer
456 participantsStarted 2026-08-01
Plain-language summary
In recent years, the successful application of cyclin-dependent kinase 4/6 inhibitors (CDK4/6i) has transformed the treatment landscape for HR+/HER2- advanced breast cancer and driven research into their use in adjuvant settings. Large Phase III trials including MONARCH-E and NATALEE have demonstrated that combining CDK4/6i with standard endocrine therapy significantly reduces the risk of recurrence or death in high-risk patients with early breast cancer. This regimen has been recommended by leading domestic and international clinical guidelines. Nevertheless, patients' quality of life, symptom burden and treatment adherence are also critical in clinical practice. Patient-reported outcomes (PROs), especially electronic PROs (ePROs), can effectively complement conventional study endpoints and provide important evidence for the comprehensive evaluation of long-term treatment.
This is a prospective, multicenter, randomized controlled clinical trial. The primary objective is to compare the tolerability of dalpiciclib versus abemaciclib/ribociclib, each combined with standard endocrine therapy, in the adjuvant treatment of patients with high-risk HR+/HER2- early breast cancer. Eligible patients who have received curative local therapy will be randomized to either the experimental group (dalpiciclib plus endocrine therapy) or the control group (ribociclib/abemaciclib plus endocrine therapy). Stratified block randomization will be applied, with stratification factors including menopausal status and prior history of neoadjuvant/adjuvant chemotherapy.
The total duration of endocrine therapy is 5 years. The treatment duration of CDK4/6i is approximately 104 weeks for dalpiciclib, 156 weeks for ribociclib, and 104 weeks for abemaciclib. CDK4/6i will be discontinued in cases of disease recurrence, intolerable toxicity, patient withdrawal, or discontinuation as determined by the investigator. Patients will be regularly asked to complete ePRO questionnaires throughout the treatment period.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Age ≥18 years with clinical stage II-III breast cancer at the time of signing informed consent.
. Post-operative pathological confirmation of invasive breast cancer that is hormone receptor-positive (HR+) and human epidermal growth factor receptor 2-negative (HER2-), as confirmed by the research center's pathology department:
. Pathologically confirmed unilateral primary invasive breast cancer, with the date of breast cancer diagnosis on the pathology report no more than 18 months before randomization. For patients with multicentric or multifocal tumors, all pathologically examined lesions must meet the pathological requirements in criterion .
. For patients who received adjuvant chemotherapy: the last chemotherapy dose must be at least 21 days before randomization.
. For patients who received adjuvant radiotherapy: the last radiotherapy session must be at least 14 days before randomization.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Rate of CDK4/6 inhibitor dose reduction or permanent discontinuation due to any cause by Week 12
Timeframe: From randomization up to Week 12 (Day 84, ±7 days)
. The last non-endocrine treatment (including surgery, radiotherapy, chemotherapy) must be within 90 days before randomization.
. Has undergone curative surgical resection with tumor-free margins on pathological examination, and meets one of the following high-risk categories:
. Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
Exclusion criteria
3. Has voluntarily signed the informed consent form, and is willing and able to comply with scheduled visits, treatment plan, laboratory tests, and other study procedures.
. Pathological diagnosis of HER2-positive breast cancer (HER2-positive defined as immunohistochemistry \[IHC\] 3+ or positive by in situ hybridization \[ISH\]).
. Local or regional recurrence of breast malignancy.
. Clinical stage IV (metastatic) breast cancer.
. Bilateral breast cancer (including contralateral carcinoma in situ).
. History of any malignancy other than breast cancer within 5 years before randomization, excluding adequately treated cervical carcinoma in situ, basal cell carcinoma, or squamous cell carcinoma of the skin.
. History of severe pulmonary disease such as interstitial pneumonia.
. Prior treatment with any CDK4/6 inhibitor, other anti-cancer biologic therapy, targeted therapy, or cancer immunotherapy.