HR Positive HER2 Negative Advanced Breast CancerPhase 2NCT07285382
Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
A Phase 2 study testing Dalpiciclib 125mg, Dalpiciclib 150mg and Letrozole 2.5mg in people with HR Positive HER2 Negative Advanced Breast Cancer, run by wanghaibo at 2 sites in China.
Trial summary
This study is a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- HR Positive HER2 Negative Advanced Breast Cancer
- What is being tested?
- Dalpiciclib 125mg, Dalpiciclib 150mg and Letrozole 2.5mg
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 2 sitesChina
- Study dates
- 25 Jun 2025to 31 Dec 2028
- Phase
- Phase 2
- 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 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female patients aged ≥18 years and ≤75 years, who are postmenopausal or premenopausal/perimenopausal, and meet one of the following conditions:
- Have undergone bilateral oophorectomy in the past, or be aged ≥60 years; or
- Aged <60 years, in a natural postmenopausal state (defined as spontaneous cessation of regular menstruation for at least 12 consecutive months without other pathological or physiological causes), with E2 and FSH at postmenopausal levels; or
- Premenopausal or perimenopausal female patients can also be enrolled, but must be willing to receive LHRH agonist treatment during the study period
- Patients with breast cancer confirmed by pathological examination to be HR-positive and HER2-negative, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiotherapy with the goal of cure, and without clinical indications for chemotherapy.
- ER-positive and/or PR-positive is defined as: the proportion of tumor cells with positive staining among all tumor cells is ≥1% (reviewed and confirmed by the investigator at the participating trial center);
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- HER2-negative is defined as: standard immunohistochemistry (IHC) test result is 0/1+; ISH test shows that the HER2/CEP17 ratio is less than 2.0 or the HER2 gene copy number is less than 4 (reviewed and confirmed by the investigator at the participating trial center)
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Have not previously received any systemic antineoplastic treatment for focal recurrent or metastatic disease
- Have measurable lesions in line with RECIST 1.1 criteria or only bone metastatic lesions (including osteolytic lesions or mixed osteolytic/osteoblastic lesions)
- Have sufficient organ and bone marrow function
- Women of childbearing potential must be willing to use a medically approved highly effective contraceptive method during the study period and within 3 months after the last administration of the study drug
- All acute toxic effects of previous antineoplastic treatment have resolved to grade 0-1 (according to NCI-CTCAE Version 5.0) or to the level specified in the inclusion/exclusion criteria. Except for other toxicities such as alopecia that the investigator deems to pose no safety risk to the patient
- Have given informed consent and signed the informed consent form, and be willing and able to comply with the planned visits, study treatment plan, laboratory tests and other trial procedures
Who cannot join
- Previously diagnosed with HER2-positive breast cancer by pathological examination
- Inflammatory breast cancer
- Disease progression or recurrence at 12 months or within 12 months after completion of previous neoadjuvant or adjuvant endocrine drug treatment
- Patients judged by the investigator to be unsuitable for endocrine treatment. Including advanced patients with symptoms, disseminated to internal organs, and at risk of life-threatening complications in the short term (including those with uncontrollable large effusions [pleural, pericardial, peritoneal], lymphangitis of the lung, and patients with more than 50% liver involvement) Confirmed to have brain metastatic lesions by cranial CT or MRI examination
- Have previously received any CDK4/6 inhibitor drug treatment
- Underwent major surgery, chemotherapy, radiotherapy, any investigational drug or other anticancer treatment within 2 weeks before entering the study Diagnosed with any other malignant tumor within 3 years before entering the study, except for non-melanoma skin cancer, basal cell or squamous cell skin cancer, or carcinoma in situ of the cervix that have undergone radical treatment Human Immunodeficiency Virus (HIV) infection or known to have Acquired Immunodeficiency Syndrome (AIDS), active hepatitis B (HBV DNA ≥1000 IU/ml), hepatitis C (positive hepatitis C antibody and HCV-RNA higher than the lower limit of detection of the analytical method), or co-infection with hepatitis B and hepatitis C
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- Within 6 months before entering the study, the following occurred: myocardial infarction, severe/unstable angina pectoris, NYHA class 2 or higher cardiac insufficiency, persistent arrhythmia of grade ≥2 (according to NCI-CTCAE Version 5.0), atrial fibrillation of any grade, coronary/peripheral artery bypass surgery, symptomatic congestive heart failure, cerebrovascular accident (including transient ischemic attack or symptomatic pulmonary embolism)
- Complicated with severe infection within 4 weeks before the first administration (e.g., requiring intravenous infusion of antibiotics, antifungal or antiviral drugs according to clinical diagnosis and treatment norms), or unexplained fever >38.5℃ during the screening period/before the first administration
- Inability to swallow, intestinal obstruction, or other factors that affect drug administration and absorption
- Known allergy to the study drug or any excipients
- Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation
- Known history of psychiatric drug abuse or drug addiction
- Patients currently participating in other studies
- Have other serious physical or mental diseases or laboratory test abnormalities that may increase the risk of participating in the study, interfere with the study results, and are deemed unsuitable for participating in this study by the investigator
Trial locations and contacts
2 sites in 1 country. Contact the study team or a site near you to ask about taking part.
China2 sites, 2 recruiting
- Recruiting
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116027
man Li, 17709873580, dmuliman@163.com
- Recruiting
Qingdao University Affiliated Hospital
Qingdao, Shandong, 266000
haibo Wang, 18661805787, hbwang66@126.com
About this study
Official title: A Multicenter, Randomized, Double-cohort Study of Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
This study is a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast cancer. A centralized randomization system (IWRS) will be used for randomization, and stratification will be performed based on the following factors during randomization: 1) Visceral metastasis (yes vs no); 2) Disease-free interval (previously untreated vs 12 < DFI ≤ 24 vs DFI > 24).
Cohort A: Dalpiciclib 125mg + Letrozole 2.5mg Cohort B: Dalpiciclib 150mg + Letrozole 2.5mg Imaging assessment will be conducted in accordance with the RECIST 1.1 criteria, and tumor imaging evaluation will be performed by investigators from the participating centers.
Read more
Patients receiving dalpiciclib will undergo a safety visit 28 days after the last dose, followed by survival follow-up until the patient's death or trial termination (whichever comes first).
Pharmacokinetic assessment: Blood samples will be collected once before dosing on Cycle 1 Day 15 (C1D15), 4 hours after dosing on C1D15, before dosing on Cycle 2 Day 1 (C2D1), and before dosing on Cycle 4 Day 1 (C4D1) to explore the population pharmacokinetic characteristics of dalpiciclib and the factors affecting its pharmacokinetics. The first dosing time of the subjects, each blood collection time, the dalpiciclib dosing time within three days before blood collection, and the dalpiciclib dosing time on the day of C1D15 blood collection must be accurately recorded. If dalpiciclib is not administered within 14 days before the planned PK blood collection, no PK blood collection will be performed on the day of that visit. If possible, PK samples should be collected simultaneously with samples for other laboratory tests.
- Being tested
- Dalpiciclib 125mg, Dalpiciclib 150mg, Letrozole 2.5mg
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Dalpiciclib 125mgDrug
Oral administration, 125mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest
Dalpiciclib 150mgDrug
Oral administration, 150mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest
Letrozole 2.5mgDrug
Oral administration, 2.5mg, administered once daily until disease progression or unacceptable toxicity
| Study group | Role | What they receive |
|---|---|---|
| Cohort A: Dalpiciclib 125mg | Experimental | Participants receive dalpiciclib 125mg orally once daily plus letrozole 2.5mg orally once daily, continued until disease progression or unacceptable toxicity Receives: Drug: Dalpiciclib 125mg; Drug: Letrozole 2.5mg |
| Cohort B: Dalpiciclib 150mg | Experimental | Participants receive dalpiciclib 150mg orally once daily plus letrozole 2.5mg orally once daily, continued until disease progression or unacceptable toxicity Receives: Drug: Dalpiciclib 150mg; Drug: Letrozole 2.5mg |
What is being measured
The primary outcome is the main question the study is designed to answer.
Progression - Free Survival (PFS)
Progression - Free Survival (PFS) is registered as 'Primary' as the most clinically impactful endpoint; other outcomes (ORR, DoR) are secondary per platform requirements, though protocol does not hierarchy
Measured: From date of randomization until the date of first documented disease progression or death from any cause (whichever comes first), assessed per RECIST 1.1 criteria up to 104 weeks
Duration of Response (DoR)
Time from first documentation of complete response (CR) or partial response (PR) to disease progression (per RECIST 1.1) or recurrence, assessed by investigators via imaging
Measured: From the date of first documented complete response (CR) or partial response (PR) (per RECIST 1.1, assessed by investigators via imaging) until the date of first documented disease progression (per RECIST 1.1) or recurrence, assessed up to 104 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Dec 2025
- Study start25 Jun 2025
- Primary completion31 Dec 2027 (estimated)
- Study completion31 Dec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for HR Positive HER2 Negative Advanced Breast CancerStudies of the same condition, open and under way.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- wanghaibo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, wanghaibo, The Affiliated Hospital of Qingdao University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07285382
- Sponsor's protocol ID
- Dose optimization of dalpicicl
- Status last verified
- Dec 2025
- First submitted
- 1 Aug 2025
- Last updated
- 16 Dec 2025
- 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 16 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-cohort Study of Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer
- ClinicalTrials.gov ID
- NCT07285382
- Acronym / sponsor ID
- Dose optimization of dalpicicl
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- wanghaiboUniversity, hospital or other
- Study start
- 25 Jun 2025 (actual)
- Primary completion
- 31 Dec 2027 (estimated)
- Study completion
- 31 Dec 2028 (estimated)
- First posted
- 16 Dec 2025 (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 a prospective, open-label, randomized, multicenter, two-cohort phase II clinical trial. Starting from December 1, 2024, it plans to enroll 120 patients with advanced first-line HR-positive, HER2-negative breast cancer. A centralized randomization system (IWRS) will be used for randomization, and stratification will be performed based on the following factors during randomization: 1) Visceral metastasis (yes vs no); 2) Disease-free interval (previously untreated vs 12 < DFI ≤ 24 vs DFI > 24).
Cohort A: Dalpiciclib 125mg + Letrozole 2.5mg Cohort B: Dalpiciclib 150mg + Letrozole 2.5mg Imaging assessment will be conducted in accordance with the RECIST 1.1 criteria, and tumor imaging evaluation will be performed by investigators from the participating centers.
Patients receiving dalpiciclib will undergo a safety visit 28 days after the last dose, followed by survival follow-up until the patient's death or trial termination (whichever comes first).
Pharmacokinetic assessment: Blood samples will be collected once before dosing on Cycle 1 Day 15 (C1D15), 4 hours after dosing on C1D15, before dosing on Cycle 2 Day 1 (C2D1), and before dosing on Cycle 4 Day 1 (C4D1) to explore the population pharmacokinetic characteristics of dalpiciclib and the factors affecting its pharmacokinetics. The first dosing time of the subjects, each blood collection time, the dalpiciclib dosing time within three days before blood collection, and the dalpiciclib dosing time on the day of C1D15 blood collection must be accurately recorded. If dalpiciclib is not administered within 14 days before the planned PK blood collection, no PK blood collection will be performed on the day of that visit. If possible, PK samples should be collected simultaneously with samples for other laboratory tests.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Cohort A: Dalpiciclib 125mg | Experimental | Drug: Dalpiciclib 125mg, Drug: Letrozole 2.5mgParticipants receive dalpiciclib 125mg orally once daily plus letrozole 2.5mg orally once daily, continued until disease progression or unacceptable toxicity |
| Cohort B: Dalpiciclib 150mg | Experimental | Drug: Dalpiciclib 150mg, Drug: Letrozole 2.5mgParticipants receive dalpiciclib 150mg orally once daily plus letrozole 2.5mg orally once daily, continued until disease progression or unacceptable toxicity |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Female patients aged ≥18 years and ≤75 years, who are postmenopausal or premenopausal/perimenopausal, and meet one of the following conditions:
- Patients with breast cancer confirmed by pathological examination to be HR-positive and HER2-negative, with evidence of focal recurrence or metastasis, not suitable for surgical resection or radiotherapy with the goal of cure, and without clinical indications for chemotherapy.
- Eastern Cooperative Oncology Group (ECOG) performance status score of 0-1
- Have not previously received any systemic antineoplastic treatment for focal recurrent or metastatic disease
- Have measurable lesions in line with RECIST 1.1 criteria or only bone metastatic lesions (including osteolytic lesions or mixed osteolytic/osteoblastic lesions)
Key exclusion criteria (14 listed)
- Previously diagnosed with HER2-positive breast cancer by pathological examination
- Inflammatory breast cancer
- Disease progression or recurrence at 12 months or within 12 months after completion of previous neoadjuvant or adjuvant endocrine drug treatment
- Patients judged by the investigator to be unsuitable for endocrine treatment. Including advanced patients with symptoms, disseminated to internal organs, and at risk of life-threatening complications in the short term (including those with uncontrollable large effusions [pleural, pericardial, peritoneal], lymphangitis of the lung, and patients with more than 50% liver involvement) Confirmed to have brain metastatic lesions by cranial CT or MRI examination
- Have previously received any CDK4/6 inhibitor drug treatment
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 125mgOral administration, 125mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest | Drug | Cohort A: Dalpiciclib 125mg |
| Dalpiciclib 150mgOral administration, 150mg，Dalpiciclib is administered for 3 weeks, followed by 1 week of rest | Drug | Cohort B: Dalpiciclib 150mg |
| Letrozole 2.5mgOral administration, 2.5mg, administered once daily until disease progression or unacceptable toxicity | Drug | Cohort A: Dalpiciclib 125mg, Cohort B: Dalpiciclib 150mg |
Primary outcome
Progression - Free Survival (PFS)
Time frame: From date of randomization until the date of first documented disease progression or death from any cause (whichever comes first), assessed per RECIST 1.1 criteria up to 104 weeks
Progression - Free Survival (PFS) is registered as 'Primary' as the most clinically impactful endpoint; other outcomes (ORR, DoR) are secondary per platform requirements, though protocol does not hierarchy
Duration of Response (DoR)
Time frame: From the date of first documented complete response (CR) or partial response (PR) (per RECIST 1.1, assessed by investigators via imaging) until the date of first documented disease progression (per RECIST 1.1) or recurrence, assessed up to 104 weeks
Time from first documentation of complete response (CR) or partial response (PR) to disease progression (per RECIST 1.1) or recurrence, assessed by investigators via imaging
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 16 Dec 2025.
- 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.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Dalpiciclib 125mg, Dalpiciclib 150mg and Letrozole 2.5mg in people with HR Positive HER2 Negative Advanced Breast Cancer, run by wanghaibo at 2 sites 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 14 inclusion and 14 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 16 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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 haibo Wang (18661805787, hbwang66@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Progression - Free Survival (PFS) (time frame: From date of randomization until the date of first documented disease progression or death from any cause (whichever comes first), assessed per RECIST 1.1 criteria up to 104 weeks). The study lists 2 primary outcomes in all. 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 16 Dec 2025.