Breast CancerNCT07706933
Tolerability of Dalpiciclib vs. Abemaciclib/Ribociclib in Early HR+/HER2- Breast Cancer
A study testing Dalpiciclib and Abemaciclib/Ribociclib in people with Breast Cancer, run by Henan Cancer Hospital.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Dalpiciclib and Abemaciclib/Ribociclib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 456 participants
- Where
- No sites listed yet
- Study dates
- 1 Nov 2026to 30 Jun 2033
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- ER positive and/or PR positive defined as ≥10% of tumor cells showing positive nuclear staining.
- HER2 negative defined as immunohistochemistry (IHC) 0 or 1+, or negative by in situ hybridization (ISH).
- 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 completed adjuvant or neoadjuvant chemotherapy(if applicable).
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- For patients who completed adjuvant radiotherapy(if applicable).
- For patients who have initiated adjuvant endocrine therapy, randomization must be completed within 12 months of the first endocrine therapy administration date.
- Has undergone curative surgical resection with tumor-free margins on pathological examination, and meets one of the following high-risk categories:
- Pathologically confirmed tumor involvement in ≥4 ipsilateral axillary lymph nodes; OR ② Pathologically confirmed tumor involvement in 1-3 ipsilateral axillary lymph nodes AND at least one of the following:
- Pathological primary invasive tumor size ≥5 cm; b. Primary tumor histological grade 3 (G3); c. Ki-67 ≥20%; d. Known genetic test indicating high risk of recurrence.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0 or 1.
- No evidence of recurrence or metastatic disease after surgery.
- Adequate organ and bone marrow function, meeting the following criteria:
- White blood cell (WBC) count ≥3,000/mm³ (3.0 × 10⁹/L) (without G-CSF within 14 days);
- Absolute neutrophil count (ANC) ≥1,500/mm³ (1.5 × 10⁹/L) (without G-CSF within 14 days);
- Platelet count (PLT) ≥100,000/mm³ (100 × 10⁹/L) (without corrective treatment within 7 days);
- Hemoglobin (Hb) ≥9 g/dL (90 g/L) (without corrective treatment within 7 days); ⑤ Serum creatinine ≤1.5 × upper limit of normal (ULN) or creatinine clearance ≥60 mL/min (without corrective treatment within 7 days); ⑥ Total bilirubin (TBIL) ≤1.5 × ULN (without corrective treatment within 7 days); ⑦ Aspartate aminotransferase (AST) and alanine aminotransferase (ALT) ≤3 × ULN (without corrective treatment within 7 days); ⑧ QTcF ≤470 ms.
- Female patients of childbearing potential must have a negative serum pregnancy test within 7 days before randomization, and must agree to use acceptable non-hormonal contraception from the signing of informed consent until 7 months after the last dose of dalpiciclib, or 21 days after the last dose of abemaciclib/ribociclib, or 2 months after the last dose of aromatase inhibitor or tamoxifen/toremifene (whichever is longer).
- All toxicities from prior anti-cancer therapy must have recovered to grade 0-1 (CTCAE version 6.0), except for those explicitly stated in the inclusion/exclusion criteria.
- 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.
Who cannot join
- 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.
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- Prior treatment with any CDK4/6 inhibitor, other anti-cancer biologic therapy, targeted therapy, or cancer immunotherapy.
- Concurrent participation in another clinical trial of anti-cancer therapy (including endocrine therapy or immunotherapy).
- Major surgical procedure, receipt of any investigational drug, other anti-cancer treatment, or use of immunomodulators within 4 weeks before randomization (excluding chemotherapy, radiotherapy, and endocrine therapy for breast cancer).
- Known infection with human immunodeficiency virus (HIV) or acquired immunodeficiency syndrome (AIDS); active hepatitis B (HBV DNA ≥500 IU/mL); hepatitis C (positive hepatitis C antibody with HCV-RNA above the lower limit of detection of the assay); or co-infection with hepatitis B and hepatitis C.
- Any of the following within 6 months before randomization: myocardial infarction, severe/unstable angina pectoris, New York Heart Association (NYHA) class ≥2 heart failure, persistent arrhythmia of grade ≥2 (according to NCI CTCAE version 6.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack), or pulmonary embolism.
- Severe infection within 4 weeks before randomization (e.g., requiring intravenous antibiotics, antifungals, or antivirals per clinical practice guidelines), or unexplained fever >38.5°C during screening or before the first dose.
- Inability to swallow, intestinal obstruction, or other factors affecting drug administration or absorption.
- Known hypersensitivity to aromatase inhibitors, tamoxifen-class drugs (e.g., tamoxifen, toremifene), and LHRH agonists; known hypersensitivity to dalpiciclib/abemaciclib/ribociclib or any of their excipients
- History of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation.
- Known history of substance abuse (including psychoactive drugs).
- Women within 1 year postpartum or currently breastfeeding.
- Presence of any other serious physical or psychiatric condition, or laboratory abnormality that may increase the risk of study participation, interfere with study results, or render the patient unsuitable for the study in the opinion of the investigator.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Tolerability of Dalpiciclib Versus Abemaciclib/Ribociclib in Combination With Standard Endocrine Therapy for HR-Positive/HER2-Negative Early Breast Cancer: A Prospective, Multicenter, Randomized Controlled Trial
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.
- Conditions
- Breast Cancer
- Being tested
- Dalpiciclib, Abemaciclib/Ribociclib
- Keywords
- HR+, early breast cancer, Dalpiciclib, ePRO
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DalpiciclibDrug
Description: 125 mg orally once daily on days 1-21 of a 28-day cycle (3 weeks on, 1 week off) for 24 months (26 cycles).
Receive 5 years of standard endocrine therapy. The recommended treatment drugs are as follows:
Letrozole Description: 2.5 mg orally once daily continuously for 5 years as part of standard endocrine therapy.
Anastrozole Description: 1 mg orally once daily continuously for 5 years as part of standard endocrine therapy. Tamoxifen Description: 10 mg orally twice daily continuously for 5 years as part of standard endocrine therapy.
Toremifene Description: 60 mg orally once daily continuously for 5 years as part of standard endocrine therapy.
Premenopausal: Preferred treatment is LHRH agonist plus an aromatase inhibitor. Perimenopausal: LHRH agonist and endocrine therapy may be used per investigator's assessment.
Goserelin Description: LHRH agonist administered subcutaneously (e.g., 3.6 mg every 28 days) for ovarian function suppression in premenopausal/perimenopausal
Abemaciclib/RibociclibDrug
Abemaciclib Description: Administered according to approved product labeling. Typical dose: 150 mg twice daily continuously for 24 months. Investigator's choice between abemaciclib and ribociclib.
Ribociclib Description: Administered according to approved product labeling. Typical dose: 400 mg orally once daily (3 weeks on, 1 week off) for 36 months. Investigator's choice between abemaciclib and ribociclib.
Receive 5 years of standard endocrine therapy. The recommended treatment drugs are as follows:
Letrozole Description: 2.5 mg orally once daily continuously for 5 years as part of standard endocrine therapy.
Anastrozole Description: 1 mg orally once daily continuously for 5 years as part of standard endocrine therapy.
Tamoxifen Description: 10 mg orally twice daily continuously for 5 years as part of standard endocrine therapy.
Toremifene Description: 60 mg orally once daily continuously for 5 years as part of standard endocrine therapy.
Premenopausal: Preferred treatment is LHRH
| Study group | Role | What they receive |
|---|---|---|
| Experimental: Dalpiciclib + Standard Endocrine Therapy | Experimental | Participants will receive Dalpiciclib 125 mg orally once daily on days 1-21 of a 28-day cycle (3 weeks on, 1 week off) for 24 months (26 cycles). In addition, participants will receive standard adjuvant endocrine therapy for 5 years. The choice of endocrine therapy depends on menopausal status:
Premenopausal/perimenopausal: LHRH agonist (goserelin or leuprorelin) + aromatase inhibitor (letrozole or anastrozole) or tamoxifen/toremifene if intolerant to aromatase inhibitor.
Postmenopausal: aromatase inhibitor (letrozole or anastrozole) or tamoxifen/toremifene if intolerant to aromatase inhibitor.
Endocrine therapy is administered continuously every 28 days. Receives: Drug: Dalpiciclib |
| Control：Abemaciclib/Ribociclib + Standard Endocrine Therapy | Active comparator | Participants will receive either Abemaciclib or Ribociclib according to the approved product labeling for dose, administration, and treatment duration. Abemaciclib is given for 24 months; Ribociclib is given for 36 months (as per label). In addition, participants will receive the same 5-year standard adjuvant endocrine therapy as described in Arm 1, based on menopausal status. The choice between Abemaciclib and Ribociclib is at the investigator's discretion following local guidelines. Receives: Drug: Abemaciclib/Ribociclib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rate of CDK4/6 inhibitor dose reduction or permanent discontinuation due to any cause by Week 12
Rate of CDK4/6 inhibitor dose reduction or permanent discontinuation due to any cause by Week 12
Measured: From randomization up to Week 12 (Day 84, ±7 days)
Secondary outcomes (7)
Health-Related Quality of Life - Time to Deterioration (HRQOL-TTD)
Time from randomization to the first clinically meaningful deterioration (defined as a ≥10-point decrease from baseline) in global health status/quality of life score measured by the EORTC QLQ-C30 (version 3.0). Death before deterioration is handled as a competing risk event.
Measured: Up to 5 years (from randomization until deterioration, death, or end of study)
Change in Functional Domain Scores
Change from baseline in physical, role, cognitive, emotional, and social functioning scores measured by the EORTC QLQ-C30 at months 1, 3, 6, 12, 18, and 24. Mixed model for repeated measures (MMRM) will be used to compare trajectories between arms.
Measured: Baseline to month 24
. Safety - Incidence and Severity of Adverse Events
Incidence, severity (graded by NCI-CTCAE version 6.0), and duration of all-grade and grade ≥3 adverse events, serious adverse events (SAEs), adverse events leading to dose modification or treatment discontinuation, and adverse events related to study drugs.
Measured: From signing of informed consent until 28 days after last dose of study drug (up to approximately 5.5 years)
Rate of CDK4/6 Inhibitor Dose Reduction or Permanent Discontinuation by Month 6
Proportion of participants with a permanent dose reduction or permanent discontinuation of the CDK4/6 inhibitor due to any cause by month 6 (Day 168, window ±14 days), using the same definition as the primary endpoint.
Measured: From randomization up to month 6 (Day 168, ±14 days)
Treatment Adherence - Median Treatment Duration and Relative Dose Intensity
Median duration of CDK4/6 inhibitor treatment (in months) and relative dose intensity (actual delivered dose / planned dose × 100%) for each treatment arm.
Measured: From start of treatment to end of CDK4/6 inhibitor treatment period (up to 24 months for dalpiciclib/abemaciclib, up to 36 months for ribociclib)
Health Economic Outcome - Quality-Adjusted Life Years (QALYs)
Quality-adjusted life years calculated from EQ-5D-5L utility scores using a country-specific value set. Differences in QALYs between arms will be estimated using a generalized linear model, and incremental cost-effectiveness ratios (ICERs) will be calculated.
Measured: From baseline through 5 years of follow-up
Invasive Disease-Free Survival (iDFS)
Time from randomization to the first occurrence of any of the following events: invasive ipsilateral or contralateral breast cancer recurrence, local/regional invasive recurrence, distant recurrence, second primary invasive cancer (non-breast), or death from any cause.
Measured: From randomization up to 5 years (or until event, censoring, or study completion)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Jul 2026
- Study start1 Nov 2026 (estimated)
- Primary completion30 Jun 2028 (estimated)
- Study completion30 Jun 2033 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Henan Cancer HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 456 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Zhenzhen Liu, Henan Cancer Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07706933
- Sponsor's protocol ID
- MA-BC-III-140
- Status last verified
- Oct 2026
- First submitted
- 11 Jul 2026
- Last updated
- 27 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Tolerability of Dalpiciclib Versus Abemaciclib/Ribociclib in Combination With Standard Endocrine Therapy for HR-Positive/HER2-Negative Early Breast Cancer: A Prospective, Multicenter, Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07706933
- Acronym / sponsor ID
- MA-BC-III-140
- Conditions
- Breast Cancer
- Keywords
- HR+, early breast cancer, Dalpiciclib, ePRO
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 456 participants (estimated)
- Lead sponsor
- Henan Cancer HospitalOther government
- Study start
- 1 Nov 2026 (estimated)
- Primary completion
- 30 Jun 2028 (estimated)
- Study completion
- 30 Jun 2033 (estimated)
- First posted
- 16 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Experimental: Dalpiciclib + Standard Endocrine Therapy | Experimental | Drug: DalpiciclibParticipants will receive Dalpiciclib 125 mg orally once daily on days 1-21 of a 28-day cycle (3 weeks on, 1 week off) for 24 months (26 cycles). In addition, participants will receive standard adjuvant endocrine therapy for 5 years. The choice of endocrine therapy depends on menopausal status: Premenopausal/perimenopausal: LHRH agonist (goserelin or leuprorelin) + aromatase inhibitor (letrozole or anastrozole) or tamoxifen/toremifene if intolerant to aromatase inhibitor. Postmenopausal: aromatase inhibitor (letrozole or anastrozole) or tamoxifen/toremifene if intolerant to aromatase inhibitor. Endocrine therapy is administered continuously every 28 days. |
| Control：Abemaciclib/Ribociclib + Standard Endocrine Therapy | Active comparator | Drug: Abemaciclib/RibociclibParticipants will receive either Abemaciclib or Ribociclib according to the approved product labeling for dose, administration, and treatment duration. Abemaciclib is given for 24 months; Ribociclib is given for 36 months (as per label). In addition, participants will receive the same 5-year standard adjuvant endocrine therapy as described in Arm 1, based on menopausal status. The choice between Abemaciclib and Ribociclib is at the investigator's discretion following local guidelines. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (21 listed)
- 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 completed adjuvant or neoadjuvant chemotherapy(if applicable).
- For patients who completed adjuvant radiotherapy(if applicable).
Key exclusion criteria (18 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DalpiciclibDescription: 125 mg orally once daily on days 1-21 of a 28-day cycle (3 weeks on, 1 week off) for 24 months (26 cycles). Receive 5 years of standard endocrine therapy. The recommended treatment drugs are as follows: Letrozole Description: 2.5 mg orally once daily continuously for 5 years as part of standard endocrine therapy. Anastrozole Description: 1 mg orally once daily continuously for 5 years as part of standard endocrine therapy. Tamoxifen Description: 10 mg orally twice daily continuously for 5 years as part of standard endocrine therapy. Toremifene Description: 60 mg orally once daily continuously for 5 years as part of standard endocrine therapy. Premenopausal: Preferred treatment is LHRH agonist plus an aromatase inhibitor. Perimenopausal: LHRH agonist and endocrine therapy may be used per investigator's assessment. Goserelin Description: LHRH agonist administered subcutaneously (e.g., 3.6 mg every 28 days) for ovarian function suppression in premenopausal/perimenopausal | Drug | Experimental: Dalpiciclib + Standard Endocrine Therapy |
| Abemaciclib/RibociclibAbemaciclib Description: Administered according to approved product labeling. Typical dose: 150 mg twice daily continuously for 24 months. Investigator's choice between abemaciclib and ribociclib. Ribociclib Description: Administered according to approved product labeling. Typical dose: 400 mg orally once daily (3 weeks on, 1 week off) for 36 months. Investigator's choice between abemaciclib and ribociclib. Receive 5 years of standard endocrine therapy. The recommended treatment drugs are as follows: Letrozole Description: 2.5 mg orally once daily continuously for 5 years as part of standard endocrine therapy. Anastrozole Description: 1 mg orally once daily continuously for 5 years as part of standard endocrine therapy. Tamoxifen Description: 10 mg orally twice daily continuously for 5 years as part of standard endocrine therapy. Toremifene Description: 60 mg orally once daily continuously for 5 years as part of standard endocrine therapy. Premenopausal: Preferred treatment is LHRH | Drug | Control：Abemaciclib/Ribociclib + Standard Endocrine Therapy |
Primary outcome
Rate of CDK4/6 inhibitor dose reduction or permanent discontinuation due to any cause by Week 12
Time frame: From randomization up to Week 12 (Day 84, ±7 days)
Rate of CDK4/6 inhibitor dose reduction or permanent discontinuation due to any cause by Week 12
7 secondary outcomes
Health-Related Quality of Life - Time to Deterioration (HRQOL-TTD)
Time frame: Up to 5 years (from randomization until deterioration, death, or end of study)
Change in Functional Domain Scores
Time frame: Baseline to month 24
. Safety - Incidence and Severity of Adverse Events
Time frame: From signing of informed consent until 28 days after last dose of study drug (up to approximately 5.5 years)
Rate of CDK4/6 Inhibitor Dose Reduction or Permanent Discontinuation by Month 6
Time frame: From randomization up to month 6 (Day 168, ±14 days)
Treatment Adherence - Median Treatment Duration and Relative Dose Intensity
Time frame: From start of treatment to end of CDK4/6 inhibitor treatment period (up to 24 months for dalpiciclib/abemaciclib, up to 36 months for ribociclib)
Health Economic Outcome - Quality-Adjusted Life Years (QALYs)
Time frame: From baseline through 5 years of follow-up
Invasive Disease-Free Survival (iDFS)
Time frame: From randomization up to 5 years (or until event, censoring, or study completion)
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Oct 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Questions about this trial
What is this clinical trial studying?
A study testing Dalpiciclib and Abemaciclib/Ribociclib in people with Breast Cancer, run by Henan Cancer Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 21 inclusion and 18 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 27 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Zhenzhen Liu (13603862755, zlyyliuzhenzhen0800@zzu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Rate of CDK4/6 inhibitor dose reduction or permanent discontinuation due to any cause by Week 12 (time frame: From randomization up to Week 12 (Day 84, ±7 days)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Oct 2026.