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Updated May 2026 · ClinicalTrials.gov

RECRUITINGPhase 2INTERVENTIONAL

Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer

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

Different Doses of Dalpicicl Combined With Letrozole in the First-line Treatment of HR-positive, HER2-negative Advanced Breast Cancer (NCT07285382) is a Phase 2 interventional studying HR Positive HER2 Negative Advanced Breast Cancer, sponsored by wanghaibo. RECRUITING as of the most recent ClinicalTrials.gov update. Talk to your doctor before contacting the trial site.

Important: This information is not medical advice. Talk to your doctor about whether a clinical trial is right for you.

About This Trial

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.

What Stage of Research Is This?

Phase 2 trials evaluate whether a treatment actually works against HR Positive HER2 Negative Advanced Breast Cancer and continue monitoring side effects. Phase 2 enrolls larger groups (typically 100–300 patients) and produces the first real efficacy signal. A successful Phase 2 readout is what unlocks the much larger Phase 3 confirmatory trials needed for FDA approval.

This trial is currently recruiting participants. The sponsor has registered the study with ClinicalTrials.gov as actively enrolling, which means new applicants who meet the eligibility criteria can be considered for screening. Trial status can change between updates — confirm current recruiting status with the study contact before traveling for a screening visit.

Target enrollment of 120 participants puts this in the typical range for a Phase 2-style efficacy study or a moderate Phase 3 trial in a focused HR Positive HER2 Negative Advanced Breast Cancer subpopulation. At this scale, the study has enough statistical power to detect a clear treatment effect but is not the largest cohort in the field.

Who May Be Eligible (Plain English)

Who May Qualify: - Female patients aged ≥18 years and ≤75 years, who are postmenopausal or premenopausal/perimenopausal, and meet one of the following conditions: 1. Have undergone bilateral oophorectomy in the past, or be aged ≥60 years; or 2. 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 3. 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. 1. 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); 2. 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 ...See full criteria on ClinicalTrials.gov Always talk to your doctor about whether this trial is right for you.

These are translations of the protocol\'s inclusion and exclusion criteria, simplified for patients and caregivers. The original clinical text appears below. Eligibility is ultimately confirmed by the trial site\'s screening process — this summary is a starting point for a conversation with your doctor, not a final determination.

Original Eligibility Criteria

View original clinical language
Inclusion Criteria: * Female patients aged ≥18 years and ≤75 years, who are postmenopausal or premenopausal/perimenopausal, and meet one of the following conditions: 1. Have undergone bilateral oophorectomy in the past, or be aged ≥60 years; or 2. 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 3. 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. 1. 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); 2. 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 Exclusion Criteria: * 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 * 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

Treatments Being Tested

DRUG

Dalpiciclib 125mg

Oral administration, 125mg,Dalpiciclib is administered for 3 weeks, followed by 1 week of rest

DRUG

Dalpiciclib 150mg

Oral administration, 150mg,Dalpiciclib is administered for 3 weeks, followed by 1 week of rest

DRUG

Letrozole 2.5mg

Oral administration, 2.5mg, administered once daily until disease progression or unacceptable toxicity

Locations (2)

Trial sites listed on ClinicalTrials.gov for this study. Site activation status can vary — confirm with the specific site before traveling for a screening visit.

The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, China
Qingdao University Affiliated Hospital
Qingdao, Shandong, China

How to Talk to Your Doctor About This Trial

Bring the printable summary of this trial — including the NCT ID (NCT07285382), the sponsor (wanghaibo), and the key eligibility criteria — to your next appointment. Your doctor can review the inclusion and exclusion criteria against your medical history, lab values, and current treatments to assess whether you are likely to qualify. They can also help you weigh whether trial participation makes sense alongside your existing care plan.

Useful questions to walk through together: What does the trial protocol require beyond standard care? How long is the active treatment phase, and how long is follow-up? Are there study visits at sites I can reach? Who pays for the trial-specific procedures, and who pays for standard-of-care portions? See our 25 questions to ask about clinical trials guide for a more complete checklist.

Authoritative Sources

The official record for this trial lives on ClinicalTrials.gov — the federal registry maintained by the National Library of Medicine at NIH. For background on how this trial fits into the FDA approval pathway, see the FDA drug approval process. For oncology-specific guidance for patients considering trials, the National Cancer Institute publishes patient-oriented overviews. International trial registries are aggregated by the WHO ICTRP.

Frequently Asked Questions

What is the NCT07285382 clinical trial studying?

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 … The full protocol is registered on ClinicalTrials.gov and includes the primary outcome measures, eligibility criteria, and study endpoints.

Who can participate in NCT07285382?

Eligibility for this trial depends on the specific inclusion and exclusion criteria set by the sponsor. The plain-English summary above translates the most important criteria into accessible language; the official clinical text is preserved in the collapsible section underneath. Whether you fit any specific trial is a medical decision your doctor needs to confirm — bring the trial information to your treating physician for a full review against your medical history.

How do I contact the trial site for NCT07285382?

Contact information registered with ClinicalTrials.gov is shown in the sidebar of this page. Before reaching out, confirm with your treating physician that this trial is appropriate for your situation. The trial site will then walk you through the screening process to determine final eligibility.

Is participating in a clinical trial safe?

Clinical trials in the United States are regulated by the FDA and overseen by Institutional Review Boards (IRBs) that review the protocol for safety. Risk varies by trial — Phase 1 studies test new treatments in humans for the first time, while Phase 3 trials use treatments that have already passed earlier safety screening. The informed consent document for any specific trial details the known risks and what to expect. Discuss those risks with your physician before deciding whether to participate.

Where can I verify the data on this page?

Every detail on this page comes directly from the ClinicalTrials.gov API. Click "View on ClinicalTrials.gov" in the sidebar to see the official, unmodified record. The federal record is always authoritative; this page is a structured presentation with a plain-English eligibility translation. For background on how clinical trials are regulated, see the FDA drug approval process documentation.

How This Page Is Built

Every field on this page is pulled directly from the ClinicalTrials.gov API v2 — no estimates, no proxies. The plain-English eligibility translation is generated from the original protocol text and reviewed for fidelity to the underlying clinical criteria. The original clinical text remains visible in the collapsible section above so users and clinicians can verify the translation. Read the full methodology for the data pipeline and known limitations.

Source: ClinicalTrials.gov API v2 record for NCT07285382. Maintained by the National Library of Medicine at NIH. Public domain. Cite as: "TrialFinderData. NCT07285382. Data: ClinicalTrials.gov."

Medical disclaimer: This page is informational, not medical advice. Talk to your doctor about whether a clinical trial is right for you.

Last updated 2026-05-08 · Data from ClinicalTrials.gov.