Could a pill replace an IV for advanced breast cancer treatment?

NCT ID NCT07684456

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This Phase 3 trial compares two forms of the chemotherapy drug utidelone—a capsule taken by mouth versus an injection—both combined with another chemo drug, capecitabine, in people with HER-2 negative advanced breast cancer. The study aims to see if the oral capsule works as well as the injection at delaying cancer growth. About 308 participants with advanced or metastatic breast cancer are being enrolled.

What this could mean

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

Active substance
Utidelone (a chemotherapy drug) given as a capsule or injection, combined with capecitabine
What this could lead to
If successful, this could provide a more convenient oral option for treating advanced breast cancer, potentially improving quality of life while controlling the disease.
What could go wrong
This is a Phase 3 trial, but results may not show a significant benefit over existing treatments. Side effects from chemotherapy, such as nausea, fatigue, and nerve damage, are possible.

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 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 308 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

Mar 2029

An estimate. End dates often move.

Lead sponsor

A company

The lead sponsor is a pharmaceutical, biotech, or medical-device company.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 75 years

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. Patients who have fully understood the objectives, content, process of the study and possible adverse events, voluntarily serves as a subject and signs the informed consent form. 2. Subjects aged ≥18 and ≤75. 3. Male or female subjects with ECOG performance status scored 0-1. 4. Patients who were diagnosed with HER-2 negative advanced breast cancer by histopathology. 5. Patients with locally advanced,recurrent,or metastatic breast cancer. 6. Patients who had received chemotherapy regimens, including at least one taxanes or anthracyclines. 7. Patients with hormone receptor positive should have disease progression after endocrine therapy. 8. At least one measurable lesion present according to RECIST 1.1 criteria. 9. Expected survival time ≥ 12 weeks 10. Baseline routine blood tests is normal. 11. Liver and kidney function test results are normal. 12. Fertile males and females of childbearing potential must agree to use effective contraception (so do their partners, using hormonal or barrier contraception, or abstinence) during the study and within at least 6 months after the last dose. The blood or urine pregnancy test for female patients of childbearing potential prior to enrollment must be negative. Exclusion Criteria: 1. Patients who have received non-investigational anti-tumor therapies within 4 weeks prior to study drug administration. 2. Patients who have used Capecitabine or Utidelone within 6 months prior to randomization. 3. Patients with breast cancer with CNS metastases leptomeningeal metastases. 4. Patients with uncontrollable bone metastases,existing or recent risk of fracture, recent need for surgery or local radiotherapy, or other critical conditions. 5. Patients with uncontrollable pleural effusion,pericardial effusion or ascites requiring repeated drainage(once a month or more) 6. Patients with serious cardiovascular disease. 7. Patients with mental illnesses which are hard to control, patients who lack legal capacity or have limited legal capacity. 8. Patients with gastrointestinal disorders affecting oral administration. 9. Patients with active infections and need systemic therapy currently. 10. Patients with peripheral neuropathy grade≥2 during randomization. 11. Patients with toxicity grade ≥2 which caused by prior anti-tumor therapy.(NCI-CTCAE 5.0,except for what is considered no safety risk such as alopecia by investigator.) 12. Patients who have received any major surgery(except for diagnostic procedures such as biopsy),or have sustained major trauma within 4 weeks to randomization;or is expected to undergo major surgery during the treatment. 13. Patients who have received radiotherapy within 2 weeks to randomization. 14. Patients who have received interventional therapy in another clinical trail or have received other investigational treatments. 15. Patients with other malignant tumor within 5 years to randomization excluding curatively treated cervical carcinoma in situ, cutaneous basal cell carcinoma or squamous cell carcinoma, and papillary thyroid carcinoma. 16. Patients with allergy of caster oil:patients with previous fluorouracil medication history with severe allergy or known dihydropyrimidine dehydrogenase (DPD) deficiency; 17. Pregnant or lactating patients. 18. Patients who, in the opinion of the investigator, are 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

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, China

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