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New combo aims to shield bone marrow in tough breast cancer

NCT ID NCT07255612

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 26, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This phase 2 trial tests whether adding trilaciclib to the chemotherapy drug eribulin can protect bone marrow in people with advanced triple-negative breast cancer who have already tried at least two chemotherapies. The study will enroll 29 participants and measure how often severe low white blood cell counts occur. The goal is to reduce dangerous side effects like infections and fatigue, helping patients stay on treatment longer.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
trilaciclib and eribulin
What this could lead to
If it works, this could reduce severe side effects from chemotherapy, allowing patients to complete treatment more safely.
What could go wrong
This is a small, early-phase trial with only 29 participants, so results may not apply broadly. The drug combination may not work or could cause unexpected side effects.

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 29 people

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

Expected to start

Nov 2026

An estimate. Start dates often move.

Expected to finish

Dec 2026

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 years and older

Sex

Anyone

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: 1. ≥18 years old , no limitation of gender; 2. locally advanced or metastatic triple-negative breast cancer; 3. have received at least two prior chemotherapy regimens(The recurrence of the last adjuvant chemotherapy is counted one line within 12 months after surgery); 4. At least one measurable lesion according to RECIST version 1.1; 5. The laboratory tests meet the following criteria: Hemoglobin: ≥ 100 g / L (female), 110g / L (male) Neutrophil count : ≥2×10\^9/L Platelet count: ≥100×10\^9/L Creatinine:≤15mg / L or creatinine clearance (CrCl) ≥60 mL/min (Cockcroft-Gault formula); Total bilirubin:≤1.5× upper limit of normal (ULN) Alutamate aminotransferase (ALT) and glutamate aminotransferase (AST)≤ 3 ×ULN or 5 ×ULN (for patients with liver metastases) Albumin: ≥ 30 g / L; 6. Eastern Cooperative Oncology Group (ECOG) score \[0-1\] points; 7. The expected survival period is ≥3 months; 8. During the screening period, all female with potential fertility must have negative serum pregnancy tests and reliable contraception after signing the informed consent form until 3 months after the last dose; 9. Comprehend and voluntarily sign the informed consent form; Exclusion Criteria: 1. Diagnosed other malignant disease besides breast cancerwithin 5 years before the first dose (excluding radical skin basal cell carcinoma, skin squamous epithelial carcinoma, and / or radical resection); 2. Main organ function not good enough; 3. Bone marrow invasion; 4. Require combined chemotherapy other than Eribulin; 5. Stroke or cardiovascular and cerebrovascular events within 6 months before enrollment; 6. QTcF \> 480 msec ( screening period) and QTcF\> 500 msec for patients with ventricular pacemaker implantation; 7. Previous hematopoietic stem cell or bone marrow transplantation; 8. Previous G-CSF treatment in the last 2 weeks; 9. Allergic to the study drug or the ingredients; 10. Any other situation where the researcher considers the patient not suitable to participate in this study.

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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.

  1. The places running it

    1 site. 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

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510000, China

More trials for these conditions

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