Den här översättningen är inte klar ännu. Den här sidan är just nu på engelska.

Gå till den engelska sidan

Can a Triple-Drug combo tackle breast cancer brain metastases?

NCT ID NCT07745257

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 2

Tests whether the treatment actually works, and watches for side effects, in a larger group.

Participants

About 40 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Jul 2028

An estimate. End dates often move.

Lead sponsor

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

18 to 80 years

Sex

Female participants only

Healthy volunteers

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

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.

Vår säkerhetsrekommendation!

Genom att skicka in godkänner du våra Användarvillkor

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.

  1. The places running it

    9 sites. The list below names each one and where it is.

  2. The official record

    ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.

    Open the record ↗

  3. 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

  • Anyang Tumor Hospital

    Anyang, Henan, 455001, China

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450008, China

  • Nanchang People's Hospital

    Nanchang, Jiangxi, 330009, China

  • Nanjing Drum Tower Hospital

    Nanjing, Jiangsu, 210008, China

  • Sichuan Provincial People's Hospital

    Chengdu, Sichuan, 610072, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang, Hebei, 050011, China

  • The Second Affiliated Hospital of Dalian Medical University

    Dalian, Liaoning, 116021, China

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022, China