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Breast CancerPhase 2NCT07539753

Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer With Brain Metastases

A Phase 2 study testing Dalpiciclib, Endocrine Therapy of Physician's Choice and Brain Radiotherapy in people with Breast Cancer and Brain Metastases, run by Nanfang Hospital, Southern Medical University at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
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Trial summary

This is a prospective, open-label, exploratory clinical trial designed to evaluate the efficacy and safety of brain radiotherapy combined with dalpiciclib and endocrine therapy in HR-positive/HER2-negative advanced breast cancer patients with brain metastases. A total of 46 patients are planned to be enrolled. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
What is being tested?
Dalpiciclib, Endocrine Therapy of Physician's Choice and Brain Radiotherapy
Could I receive a placebo?
No, everyone receives an active treatment
How many people
46 participants
Where
1 siteChina
Study dates
1 Jun 2026to 1 Aug 2029
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

  • 1.Female patients aged 18 to 75 years, who are postmenopausal or premenopausal/perimenopausal, and meet at least one of the following conditions:
  • prior bilateral oophorectomy; or age ≥60 years; or
  • age <60 years and postmenopausal status defined as at least 12 consecutive months of spontaneous amenorrhea without other pathological or physiological causes, with estradiol (E2) and follicle-stimulating hormone (FSH) levels within the postmenopausal range; or
  • premenopausal or perimenopausal women are also eligible if they are willing to receive treatment with an LHRH agonist during the study.
  • 2.Histologically or cytologically confirmed HR-positive, HER2-negative breast cancer in female patients, with evidence of locally recurrent or metastatic disease that is not amenable to curative surgery or radiotherapy, and with no clinical indication for chemotherapy.
  • HR-positive is defined as ER-positive and/or PR-positive, with ≥1% of tumor cells showing positive staining, as confirmed by the investigator at the study site.
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  • HER2-negative is defined as IHC 0 or 1+, or ISH-negative, defined as a HER2/CEP17 ratio <2.0 or an average HER2 copy number <4.0, as confirmed by the investigator at the study site.
  • 3.Presence of brain metastases confirmed by MRI, with at least one measurable intracranial lesion ≥1 cm according to RECIST version 1.1. Measurable extracranial disease is not required.
  • 4.ECOG performance status 0-2, and an estimated life expectancy of at least 12 weeks at the time of enrollment.
  • 5.If the patient is receiving corticosteroids, the corticosteroid dose must be stable or decreasing for at least 5 days before the brain gadolinium-enhanced MRI (Gd-MRI). This MRI must be performed within 28 days before enrollment. Patients who require an increased steroid dose before treatment, or who are receiving an unstable steroid dose, are not eligible.
  • 6.Screening laboratory values must meet the following criteria( and should be obtained within 14 days prior to registration)::
  • absolute neutrophil count (ANC) ≥ 1,500/mm³ (1.5 × 10^9/L), without growth factor support within 14 days;
  • platelet count (PLT) ≥ 100,000/mm³ (100 × 10^9/L), without corrective treatment within 7 days;
  • hemoglobin (Hb) ≥ 9 g/dL (90 g/L), without corrective treatment within 7 days;
  • serum creatinine (Scr) ≤ 1.5 × upper limit of normal (ULN), or creatinine clearance ≥ 60 mL/min;
  • total bilirubin ≤ 1.5 × ULN;
  • aspartate aminotransferase (AST/SGOT) and alanine aminotransferase (ALT/SGPT) ≤ 2.5 × ULN, or ≤ 5 × ULN for patients with liver metastases.
  • 7.Prior stereotactic radiosurgery (SRS) or fractionated stereotactic radiotherapy (FSRT) is permitted, provided that the currently active measurable disease has not been previously treated with radiotherapy.
  • 8.Women of childbearing potential must have a negative serum pregnancy test within 7 days before enrollment and must agree to use a medically acceptable highly effective method of contraception during the study and for 1 year after the last dose of study treatment.
  • 9.Ability and willingness to signed the informed consent form prior to patient entry.

Who cannot join

  • 1.Prior pathological diagnosis of HER2-positive breast cancer.
  • 2.Prior disease progression on dalpiciclib in the metastatic setting.
  • 3.Primary endocrine resistance, defined as either:
  • disease recurrence or progression within 2 years of starting adjuvant endocrine therapy; or
  • disease progression within 6 months of first-line endocrine therapy for advanced or metastatic disease.
  • 4.Patients considered not suitable for endocrine therapy in the judgment of the investigator, including patients with symptomatic visceral disease, disseminated visceral involvement, or a risk of life-threatening complications in the short term, such as uncontrolled massive effusions (pleural, pericardial, or peritoneal), lymphangitic carcinomatosis of the lung, or >50% liver involvement.
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  • 5.Presence of leptomeningeal metastases.
  • 6.Prior whole-brain radiotherapy (WBRT) .
  • 7.Any severe neurologic symptoms caused by central nervous system metastases.
  • 8.Pregnant or breastfeeding women.
  • 9.Any serious uncontrolled clinical disease or infection that, in the investigator's judgment, cannot be adequately controlled with appropriate treatment or may impair the patient's ability to tolerate study treatment, including but not limited to:
  • serious cardiovascular events such as syncope of cardiovascular origin, pathologic ventricular arrhythmias (including but not limited to ventricular tachycardia or ventricular fibrillation), or cardiac arrest;
  • end-stage renal disease;
  • severe liver disease;
  • active systemic bacterial infection.
  • 10.History of immunodeficiency, including HIV infection, active hepatitis B virus (HBV) infection, active hepatitis C virus (HCV) infection, other acquired or congenital immunodeficiency disorders, or prior organ transplantation.
  • 11.History of malignancy other than breast cancer.
  • 12.Inability to swallow oral medication, or presence of chronic diarrhea, intestinal obstruction, or other conditions that may interfere with the administration or absorption of study drugs.
  • 13.History of allergy or hypersensitivity to any study drug or any of its components.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Guangyu Yao, MD PhD contact

+86-13570966868

yaogy@sum.edu.cn

China1 site

  • Nanfang Hospital, Southern Medical University

    Guangzhou, Guangdong, 510515

    Guangyu Yao, MD PhD, +86-13570966868, yaogy@sum.edu.cn

Other trials in China

About this study

Official title: A Single-Arm, Phase II Study of Brain Radiotherapy Combined With Dalpiciclib and Endocrine Therapy in HR-Positive/HER2-Negative Advanced Breast Cancer Patients With Brain Metastases

This is a prospective, open-label, exploratory clinical trial designed to evaluate the efficacy and safety of brain radiotherapy combined with dalpiciclib and endocrine therapy in HR-positive/HER2-negative advanced breast cancer patients with brain metastases. A total of 46 patients are planned to be enrolled.

Participants will receive dalpiciclib plus endocrine therapy and brain radiotherapy, including fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the clinical characteristics of brain metastatic lesions. Radiotherapy may start within 30 days before or after initiation of drug treatment. Dalpiciclib and endocrine therapy may be given concurrently during radiotherapy and will be continued after radiotherapy until disease progression, intolerable toxicity, withdrawal of informed consent, or investigator decision. Participants will visit the clinic once every 3 months for checkups and tests. Tumor response will be assessed according to RECIST version 1.1, and safety will be evaluated throughout the study.

Being tested
Dalpiciclib, Endocrine Therapy of Physician's Choice, Brain Radiotherapy
Keywords
HR+/HER2- Breast Cancer, brain metastases, brain radiotherapy, dalpiciclib
Medical subject headings
Breast Neoplasms, Brain Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • DalpiciclibDrug

    Dalpiciclib will be administered orally at 125 mg once daily for 21 days followed by 7 days off in a 28-day cycle.

  • Endocrine Therapy of Physician's ChoiceDrug

    Endocrine therapy will be selected by the treating physician according to clinical practice.

  • Brain RadiotherapyRadiation

    Brain radiotherapy will include fractionated stereotactic radiotherapy (FSRT) or whole-brain radiotherapy (WBRT), according to the number, size, location, and distribution of brain metastatic lesions.

Study groups in NCT07539753
Study groupRoleWhat they receive
Dalpiciclib + Endocrine Therapy + Brain RadiotherapyExperimentalParticipants will receive dalpiciclib, endocrine therapy, and brain radiotherapy (FSRT or WBRT).
Receives: Drug: Dalpiciclib; Drug: Endocrine Therapy of Physician's Choice; Radiation: Brain Radiotherapy

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Central Nervous System Progression-Free Survival (CNS-PFS)

    CNS-PFS is measured from the date of first study treatment to the date of intracranial disease progression or death, whichever occurs first.

    Measured: 12 months

Secondary outcomes (4)

  1. Central Nervous System Objective Response Rate (CNS-ORR)

    CNS-ORR is defined as the percentage of participants whose best overall intracranial response is complete response (CR) or partial response (PR) from the start of study treatment until disease progression (determined by RECIST version 1.1).

    Measured: 12 months

  2. Progression-Free Survival (PFS)

    Defined as the time from the date of first study treatment to the first documented radiographic disease progression or death from any cause, whichever occurs first. For participants who have not experienced disease progression or death by the data cutoff date, or who start other anti-tumor therapy before documented progression, PFS will be censored at the date of the last adequate tumor assessment before the cutoff date or before the initiation of other anti-tumor therapy, whichever occurs first.

    Measured: 12 months

  3. Overall Survival (OS)

    Measured: 12 months

  4. Incidence of Adverse Events

    Safety will be evaluated based on the incidence of adverse events occurring during study treatment, including drug treatment and radiotherapy. Adverse events will be recorded and graded according to the National Cancer Institute Common Terminology Criter

    Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted20 Apr 2026
  2. Study start1 Jun 2026 (estimated)
  3. Primary completion1 Aug 2029 (estimated)
  4. Study completion1 Aug 2029 (estimated)

Resources

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
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
46 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07539753
Sponsor's protocol ID
NFEC-2025-640
Status last verified
Apr 2026
First submitted
13 Apr 2026
Last updated
30 Apr 2026
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: De-identified individual participant data will not be shared.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Dalpiciclib, Endocrine Therapy of Physician's Choice and Brain Radiotherapy in people with Breast Cancer and Brain Metastases, run by Nanfang Hospital, Southern Medical University 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 20 inclusion and 19 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 30 Apr 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 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 Guangyu Yao, MD PhD (+86-13570966868, yaogy@sum.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Central Nervous System Progression-Free Survival (CNS-PFS) (time frame: 12 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07539753.

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 30 Apr 2026.

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