Can a Triple-Drug combo tackle breast cancer brain metastases?
NCT ID NCT07745257
First seen Aug 04, 2026 · Last updated Aug 05, 2026 · Updated 1 time
Summary
This phase 2 trial is testing whether adding anlotinib to a combination of culmerciclib and endocrine therapy can control disease in people with HR-positive, HER2-negative breast cancer that has spread to the brain. The study enrolls adults with newly diagnosed or progressing brain metastases who do not need immediate local treatment. The goal is to see if this drug combination can delay brain tumor growth and improve overall outcomes.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- A combination of three drugs: culmerciclib (a CDK inhibitor), anlotinib (an anti-angiogenic agent), and standard endocrine therapy.
- What this could lead to
- If successful, this combination could offer a new treatment option to control brain metastases in HR+/HER2- breast cancer, potentially improving outcomes for a group with limited options.
- What could go wrong
- This is a small, early-phase trial, so the benefits are uncertain. The drug combination may cause side effects, and results may not apply to all patients.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 40 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Aug 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2028
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 80 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * 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 * 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: 1. No more than 3 lines of prior systemic therapy for advanced disease 2. No more than 1 line of chemotherapy or antibody-drug conjugate (ADC) administered in the advanced setting 3. 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 Exclusion Criteria: * 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 * 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
Get updates
Get notified about this study
Sign up to get updates when this study changes or when new studies for HR-positive, HER2-negative metastatic breast cancer with brain metastases are added.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
9 sites. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Anyang Tumor Hospital
Anyang, Henan, 455001, China
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Henan Cancer Hospital
Zhengzhou, Henan, 450008, China
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Nanchang People's Hospital
Nanchang, Jiangxi, 330009, China
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Nanjing Drum Tower Hospital
Nanjing, Jiangsu, 210008, China
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Sichuan Provincial People's Hospital
Chengdu, Sichuan, 610072, China
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Sun Yat-sen University Cancer Center
Guangzhou, Guangdong, 510060, China
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The Fourth Hospital of Hebei Medical University
Shijiazhuang, Hebei, 050011, China
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The Second Affiliated Hospital of Dalian Medical University
Dalian, Liaoning, 116021, China
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Zhejiang Cancer Hospital
Hangzhou, Zhejiang, 310022, China