HR-positive, HER2-negative Metastatic Breast Cancer With Brain MetastasesPhase 2NCT07745257
Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases
A Phase 2 study testing Culmerciclib, Anlotinib and Endocrine Therapy in people with HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases, run by Sun Yat-sen University at 9 sites in China.
Trial summary
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Read more about this study
- Who is it for?
- Ages 18 to 80 years, women only
- Conditions the study is for
- HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases
- What is being tested?
- Culmerciclib, Anlotinib and Endocrine Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 9 sitesChina
- Study dates
- 28 Aug 2026to 28 Jul 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 80 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Women aged ≥ 18 years
- ECOG PS of 0-1
- Life expectancy of at least 12 weeks
- histologically or cytologically documented HR+/HER2- breast cancer
- radiologically confirmed brain parenchymal metastases without the need for immediate local therapy
- measurable brain metastasis lesion according to RANO-BM criteria
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- Must have active brain metastases, defined as newly diagnosed brain metastases or progressive brain metastases following prior local therapy
- Prior systemic therapy must meet all the following criteria：
- No more than 3 lines of prior systemic therapy for advanced disease
- No more than 1 line of chemotherapy or antibody-drug conjugate (ADC) administered in the advanced setting
- No prior CDK4/6 inhibitor therapy for advanced disease, or only 1 line of CDK4/6 inhibitor therapy with treatment duration > 6 months
- Adequate hematological, hepatic and renal function
- Women of child bearing potential must agree to use a contraceptive method during the treatment period and for at least 180 days after the last dose of experiment treatment
- Patients must be able to participate and comply with treatment and follow-up
Who cannot join
- Patients with leptomeningeal metastases, brainstem metastases or skull metastases
- Prior receipt of anti-angiogenic agents or Culmerciclib
- Unresolved Grade ≥2 toxicities (per CTCAE Version 6.0) attributable to any prior therapy, except alopecia
- Patients with visceral crisis,defined as severe organ dysfunction assessed by symptoms, signs, laboratory examinations and rapid disease progression
- Inability to swallow capsules or tablets
- Any severe and/or uncontrolled medical disease
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- Other malignancies diagnosed within 5 years, excluding cured non-melanoma skin cancer, cervical carcinoma in situ and papillary thyroid carcinoma
- Radiographic evidence of tumor invasion of major vessels, or high risk of tumor invasion into major vessels resulting in life-threatening hemorrhage as assessed by the investigator
- Patients with arterial or venous thromboembolic events within 6 months, such as cerebrovascular accident, deep vein thrombosis and pulmonary embolism
- Participation in other anti-tumor clinical trials within 4 weeks prior to enrollment
- Any other condition that the investigator considers inappropriate to participate in this trial
Trial locations and contacts
9 sites in 1 country. Contact the study team or a site near you to ask about taking part.
9 sites in 1 country
China9 sites
Anyang Tumor Hospital
Anyang, Henan, 455001
Junlan Guo, +8615037272967, fanyuguo201@163.com
Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072
Jing Luo, +8618981838521, luckyluojy@163.com
The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116021
Man Li, +8617709878607, 1357396467@qq.com
Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060
Shusen Wang, MD, +8613926168469, wangshs@sysucc.org.cn
Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022
Zhanhong Chen, +8613606505124, czred@sina.com
Nanchang People's Hospital
Nanchang, Jiangxi, 330009
Wenyan Chen, +8613970890626, chenwenyannc2013@163.com
Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008
Li Xie, +8613605169652, Sherry01130@163.com
The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011
Cuizhi Geng, MD, +8613503216325, 46300349@hebmu.edu.cn
Henan Cancer Hospital
Zhengzhou, Henan, 450008
Xiaosan Zhang, +8615638167115, zxs_8112@126.com
About this study
Official title: Efficacy and Safety of Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases：a Multicenter, Single-arm, Phase Ⅱ Trial
This study aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.
- Being tested
- Culmerciclib, Anlotinib, Endocrine Therapy
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CulmerciclibDrug
180 mg orally once daily
AnlotinibDrug
12 mg orally once daily on Days 1-14 of every 3-week cycle
Endocrine TherapyDrug
administered per approved prescribing information
| Study group | Role | What they receive |
|---|---|---|
| culmerciclib plus anlotinib and endocrine therapy | Experimental | Patients receive culmerciclib plus anlotinib and endocrine therapy Receives: Drug: Culmerciclib; Drug: Anlotinib; Drug: Endocrine Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
CNS progression-free survival(CNS-PFS)
Time from treatment until disease progression or death per RANO-BM criteria
Measured: From enrollment to the end of treatment at 8 months
Secondary outcomes (5)
progression-free survival (PFS)
Time from treatment until disease progression or death
Measured: From enrollment to the end of treatment at 8 months
objective response rate (ORR)
Objective Response Rate (ORR) based on RECIST 1.1 criteria
Measured: From enrollment to the end of treatment at 8 months
intracranial objective response rate（IC-ORR)
intracranial objective response rate(ORR-IC) per RANO-BM criteria
Measured: From enrollment to the end of treatment at 8 months
Overall Survival (OS)
Time from treatment until death from any cause.
Measured: From enrollment to the end of treatment at 18 months
Safety and Adverse Events
Incidence and severity of adverse events.
Measured: From enrollment to the end of treatment at 9 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Aug 2026
- Study start28 Aug 2026 (estimated)
- Primary completion28 Dec 2027 (estimated)
- Study completion28 Jul 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 Metastatic Breast Cancer With Brain MetastasesStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 2
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 40 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, wang shusen, Sun Yat-sen University
- Investigators
- Shusen Wang, MD, Principal investigator, Sun Yat-sen University CancerCenterCuizhi Geng, MD, Principal investigator, Hebei Medical University Fourth Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07745257
- Sponsor's protocol ID
- SL-B2026-363-01
- Status last verified
- Mar 2026
- First submitted
- 30 Jul 2026
- Last updated
- 4 Aug 2026
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Culmerciclib Plus Anlotinib and Endocrine Therapy for HR-Positive/HER2-Negative Metastatic Breast Cancer With Brain Metastases：a Multicenter, Single-arm, Phase Ⅱ Trial
- ClinicalTrials.gov ID
- NCT07745257
- Acronym / sponsor ID
- SL-B2026-363-01
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 40 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- 28 Aug 2026 (estimated)
- Primary completion
- 28 Dec 2027 (estimated)
- Study completion
- 28 Jul 2028 (estimated)
- First posted
- 4 Aug 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 aims to evaluate the efficacy and safety of adding the anti-angiogenic agent anlotinib to the combination of the CDK2/4/6 inhibitor Culmerciclib and endocrine therapy in patients with HR+/HER2- breast cancer and brain metastases. Eligible patients present with newly diagnosed brain metastases or brain metastases that progressed following prior local therapy. It is hoped that this therapeutic combination can achieve disease control in these patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| culmerciclib plus anlotinib and endocrine therapy | Experimental | Drug: Culmerciclib, Drug: Anlotinib, Drug: Endocrine TherapyPatients receive culmerciclib plus anlotinib and endocrine therapy |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Women aged ≥ 18 years
- ECOG PS of 0-1
- Life expectancy of at least 12 weeks
- histologically or cytologically documented HR+/HER2- breast cancer
- radiologically confirmed brain parenchymal metastases without the need for immediate local therapy
Key exclusion criteria (11 listed)
- Patients with leptomeningeal metastases, brainstem metastases or skull metastases
- Prior receipt of anti-angiogenic agents or Culmerciclib
- Unresolved Grade ≥2 toxicities (per CTCAE Version 6.0) attributable to any prior therapy, except alopecia
- Patients with visceral crisis,defined as severe organ dysfunction assessed by symptoms, signs, laboratory examinations and rapid disease progression
- Inability to swallow capsules or tablets
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 |
|---|---|---|
| Culmerciclib180 mg orally once daily | Drug | culmerciclib plus anlotinib and endocrine therapy |
| Anlotinib12 mg orally once daily on Days 1-14 of every 3-week cycle | Drug | culmerciclib plus anlotinib and endocrine therapy |
| Endocrine Therapyadministered per approved prescribing information | Drug | culmerciclib plus anlotinib and endocrine therapy |
Primary outcome
CNS progression-free survival(CNS-PFS)
Time frame: From enrollment to the end of treatment at 8 months
Time from treatment until disease progression or death per RANO-BM criteria
5 secondary outcomes
progression-free survival (PFS)
Time frame: From enrollment to the end of treatment at 8 months
objective response rate (ORR)
Time frame: From enrollment to the end of treatment at 8 months
intracranial objective response rate（IC-ORR)
Time frame: From enrollment to the end of treatment at 8 months
Overall Survival (OS)
Time frame: From enrollment to the end of treatment at 18 months
Safety and Adverse Events
Time frame: From enrollment to the end of treatment at 9 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 4 Aug 2026.
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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.
Shusen Wang, MD principal investigator
Sun Yat-sen University CancerCenter
Cuizhi Geng, MD principal investigator
Hebei Medical University Fourth Hospital
9 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 Culmerciclib, Anlotinib and Endocrine Therapy in people with HR-positive, HER2-negative Metastatic Breast Cancer With Brain Metastases, run by Sun Yat-sen University at 9 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 11 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 4 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 9 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 Shusen Wang, MD (+8613926168469, wangshs@sysucc.org.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
CNS progression-free survival(CNS-PFS) (time frame: From enrollment to the end of treatment at 8 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 4 Aug 2026.