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New pill combo aims to keep advanced breast cancer in check

NCT ID NCT05876065

Disease control Sponsor: Wenjin Yin Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now This study
This trial is taking on new participants right now.
Not yet recruiting
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Aug 20, 2026 · Updated 2 times

Summary

This study compares a combination of two chemotherapy pills (capecitabine and cyclophosphamide) against standard maintenance treatments for women with advanced breast cancer whose disease is under control after initial therapy. The goal is to see which approach better delays cancer progression. About 86 participants will be randomly assigned to one of the two options.

What this could mean

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

Active substance
capecitabine and cyclophosphamide
What this could lead to
If successful, this could offer a new, effective maintenance option to delay disease progression in advanced breast cancer.
What could go wrong
This is a small, early-stage trial (86 participants) with no phase designation, so results may not be conclusive. The combination may cause side effects like hand-foot syndrome or low blood counts.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 86 people

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

Started

Jun 2023

Expected to finish

Feb 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 years and older

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: * Female, age≥18 years old * ECOG≤2 * Pathologically confirmed primary breast cancer, with pathologically or radiologically confirmed recurrent or metastatic lesions * HR+/HER2+ or HR-/HER2+ or HR-/HER2- * At least one measurable lesion or bone-only disease (osteolytic or mixed) according to RECIST v1.1 * Disease control (complete response + partial response + stable disease) after salvage treatment * Expected survival ≥6 months * Adequate organ function Exclusion Criteria: * during pregnancy and lactation * Patients with central nervous system metastasis

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Conditions

The condition(s) this trial relates to.

breast cancer breast carcinoma

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Advanced breast cancer

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

  • Renji Hospital, School of Medicine, Shanghai Jiaotong University

    RECRUITING

    Shanghai, 200127, China

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