Breast CancerPhase 3NCT07467330
Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine vs Dalpiciclib Combined With Endocrine Therapy for First-line Treatment
A Phase 3 study testing dalpiciclib + capecitabine + endocrine therapy and dalpiciclib + endocrine therapy in people with Breast Cancer, run by Fujian Cancer Hospital at 1 site in China.
Trial summary
This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- dalpiciclib + capecitabine + endocrine therapy and dalpiciclib + endocrine therapy
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 258 participants
- Where
- 1 siteChina
- Study dates
- 15 Nov 2025to 31 Dec 2032
- Phase
- Phase 3
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- postmenopausal or premenopausal/perimenopausal women ≥ 18 years of age who meet one of the following: a) prior bilateral oophorectomy, or ≥ 60 years of age; or b) age < 60 years, spontaneous postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; or c) premenopausal or perimenopausal women must be willing to receive LHRH agonists between studies.
- Female breast cancer patients diagnosed as HR positive and HER2 negative by pathological examination are not suitable for surgical resection or radiation therapy with the purpose of cure.
- ER-positive and/or PR-positive are defined as having positively stained tumor cells representing ≥ 1% of all tumor cells (reviewed and confirmed by the investigator at the site); b) HER2-negative are defined as having 0/1 + by standard immunohistochemistry (IHC); HER2/CEP17 ratio of less than 2.0 by ISH or HER2 gene copy number of less than 4 (reviewed and confirmed by the investigator at the site).
- ECOG score 0-2.
- Patients with new stage IV or recurrent metastases with visceral metastases are allowed to enroll patients with visceral crisis (visceral crisis definition includes but is not limited to meeting one of the following: pleural effusion; ascites; abdominal pain caused by liver or peritoneal metastases; rapid worsening of dyspnea at rest that cannot be relieved by pleural effusion drainage; rapid increase in bilirubin > 1.5 × ULN in the absence of Gilbert 's syndrome or biliary obstruction).
- adequate bone marrow function, defined as follows: a) neutrophil count (ANC) ≥ 1,500/mm3 (1.5 x 109 L) (no growth factors used within 14 days); b) platelet count (PLT) ≥ 100,000/mm3 (100 x 109 L) (no corrective treatment used within 7 days); c) hemoglobin (Hb) ≥ 8 g/dL (80 g/L) (no corrective treatment used within 14 days).
- Female subjects who are not postmenopausal or surgically sterile must have a negative serum pregnancy test within 7 days before the first dose and are willing to abstain from sexual intercourse or use a medically recognized highly effective contraceptive measure after signing informed consent, during the study, and for 1 year after the last dose of study drug.
- Voluntarily join this study, sign informed consent, have good compliance and are willing to cooperate with follow-up.
Who cannot join
- patients who have previously been treated with CDK4/6 inhibitors and/or capecitabine.
- patients who relapse within 2 years of adjuvant endocrine therapy.
- Patients with bone metastases alone regardless of recurrence, metastasis or new stage IV disease.
- patients with active brain metastases.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), hepatitis B surface antigen positive and HBV DNA ≥ 2000 IU/ml, hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method) or combined hepatitis B and hepatitis C co-infection.
- The following conditions occurred 6 months before enrollment: myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, ≥ grade 2 persistent arrhythmia (according to NCI CTCAE version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass grafting, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack) or symptomatic pulmonary embolism, and new thrombosis.
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- Complicated with severe infection within 4 weeks before the first dose (such as intravenous drip of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment specifications), or unexplained fever > 38.5℃ during screening/before the first dose.
- inability to swallow, bowel obstruction, or the presence of other factors that affect the administration and absorption of the drug.
- known hypersensitivity to regimen combination therapy drugs and any of their excipients.
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation;
- Known history of psychotropic substance abuse or drug abuse.
- Female patients who are pregnant or lactating.
- Any other condition that the investigator considers the subject unsuitable for participation in this study.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fujian Cancer Hosptial
Fuzhou, Fujian, 350001
Chuangui Song, 13960709993, songcg1971@outlook.com
About this study
Official title: Open, Randomized Controlled Study of Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine Versus Dalpiciclib Combined With Endocrine Therapy for HR +/HER2- Recurrent Metastatic Breast Cancer With Visceral Metastasis
This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).
- Conditions
- Breast Cancer
- Being tested
- dalpiciclib + capecitabine + endocrine therapy, dalpiciclib + endocrine therapy
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dalpiciclib + capecitabine + endocrine therapyDrug
The experimental arm received dalpiciclib combined with endocrine therapy and metronomic capecitabine chemotherapy
dalpiciclib + endocrine therapyDrug
Control group received dalpiciclib combined with endocrine therapy
| Study group | Role | What they receive |
|---|---|---|
| dalpiciclib + capecitabine + endocrine therapy | Experimental | Not described Receives: Drug: dalpiciclib + capecitabine + endocrine therapy |
| dalpiciclib + endocrine therapy | Active comparator | Not described Receives: Drug: dalpiciclib + endocrine therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
PFS
Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Mar 2026
- Study start15 Nov 2025
- Primary completion31 Dec 2031 (estimated)
- Study completion31 Dec 2032 (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 Fujian 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 258 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fujian Cancer Hospital
- Sponsor type
- Other government
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07467330
- Sponsor's protocol ID
- MA-BC-III-116
- Status last verified
- Mar 2026
- First submitted
- 28 Nov 2025
- Last updated
- 12 Mar 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 12 Mar 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Open, Randomized Controlled Study of Dalpiciclib Combined With Endocrine Therapy and Metronomic Capecitabine Versus Dalpiciclib Combined With Endocrine Therapy for HR +/HER2- Recurrent Metastatic Breast Cancer With Visceral Metastasis
- ClinicalTrials.gov ID
- NCT07467330
- Acronym / sponsor ID
- MA-BC-III-116
- Conditions
- Breast Cancer
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 258 participants (estimated)
- Lead sponsor
- Fujian Cancer HospitalOther government
- Study start
- 15 Nov 2025 (actual)
- Primary completion
- 31 Dec 2031 (estimated)
- Study completion
- 31 Dec 2032 (estimated)
- First posted
- 12 Mar 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.
This study is an open-label, multicenter, randomized controlled study. It is planned to include 258 patients with HR +/HER2- advanced breast cancer with visceral metastases. Eligible subjects will be randomized 1:1 to receive dalpiciclib in combination with endocrine therapy and metronomic capecitabine chemotherapy in the experimental arm and dalpiciclib in combination with endocrine therapy in the control arm. Randomization was stratified by the number of lines of therapy for recurrent metastases (0 versus 1) and endocrine therapy (AI versus fulvestrant).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| dalpiciclib + capecitabine + endocrine therapy | Experimental | Drug: dalpiciclib + capecitabine + endocrine therapy |
| dalpiciclib + endocrine therapy | Active comparator | Drug: dalpiciclib + endocrine therapy |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- postmenopausal or premenopausal/perimenopausal women ≥ 18 years of age who meet one of the following: a) prior bilateral oophorectomy, or ≥ 60 years of age; or b) age < 60 years, spontaneous postmenopausal status (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), E2 and FSH at postmenopausal levels; or c) premenopausal or perimenopausal women must be willing to receive LHRH agonists between studies.
- Female breast cancer patients diagnosed as HR positive and HER2 negative by pathological examination are not suitable for surgical resection or radiation therapy with the purpose of cure.
- ECOG score 0-2.
- Patients with new stage IV or recurrent metastases with visceral metastases are allowed to enroll patients with visceral crisis (visceral crisis definition includes but is not limited to meeting one of the following: pleural effusion; ascites; abdominal pain caused by liver or peritoneal metastases; rapid worsening of dyspnea at rest that cannot be relieved by pleural effusion drainage; rapid increase in bilirubin > 1.5 × ULN in the absence of Gilbert 's syndrome or biliary obstruction).
- adequate bone marrow function, defined as follows: a) neutrophil count (ANC) ≥ 1,500/mm3 (1.5 x 109 L) (no growth factors used within 14 days); b) platelet count (PLT) ≥ 100,000/mm3 (100 x 109 L) (no corrective treatment used within 7 days); c) hemoglobin (Hb) ≥ 8 g/dL (80 g/L) (no corrective treatment used within 14 days).
Key exclusion criteria (13 listed)
- patients who have previously been treated with CDK4/6 inhibitors and/or capecitabine.
- patients who relapse within 2 years of adjuvant endocrine therapy.
- Patients with bone metastases alone regardless of recurrence, metastasis or new stage IV disease.
- patients with active brain metastases.
- Human immunodeficiency virus (HIV) infection or known acquired immunodeficiency syndrome (AIDS), hepatitis B surface antigen positive and HBV DNA ≥ 2000 IU/ml, hepatitis C (hepatitis C antibody positive, and HCV-RNA above the lower limit of detection of the analytical method) or combined hepatitis B and hepatitis C co-infection.
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 |
|---|---|---|
| dalpiciclib + capecitabine + endocrine therapyThe experimental arm received dalpiciclib combined with endocrine therapy and metronomic capecitabine chemotherapy | Drug | dalpiciclib + capecitabine + endocrine therapy |
| dalpiciclib + endocrine therapyControl group received dalpiciclib combined with endocrine therapy | Drug | dalpiciclib + endocrine therapy |
Primary outcome
PFS
Time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months
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 12 Mar 2026.
- Individual participant dataSharing planned: No
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing dalpiciclib + capecitabine + endocrine therapy and dalpiciclib + endocrine therapy in people with Breast Cancer, run by Fujian Cancer Hospital at 1 site in China.
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 8 inclusion and 13 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: looking for participants now, as of the sponsor's last update on 12 Mar 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Chuangui Song (+8613960709993, songchuangui@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
PFS (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 20 months). 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 12 Mar 2026.