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New combo slows advanced breast cancer progression

NCT ID NCT02767661

Disease control Sponsor: Sun Yat-sen University Source: ClinicalTrials.gov ↗

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This study tested whether adding a low-dose chemotherapy pill (capecitabine) to standard hormone therapy (aromatase inhibitor) helps women with a common type of advanced breast cancer live longer without the disease getting worse. The trial involved 263 women who had not received prior treatment for their metastatic cancer. The goal was to see if the combination works better than hormone therapy alone.

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

263 people

The number who actually took part.

Started

Jul 2017

Finished

Aug 2023

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 70 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: * Adult women with locoregionally recurrent or metastatic disease not amenable to curative therapy * Confirmed diagnosis of ER positive/Her2-negative breast cancer * No prior systemic anti-cancer therapy for locoregionally recurrent or metastatic disease * Any menopausal status, but premenopausal or perimenopausal patients are required to receive LHRHa treatment * Measurable disease defined by RECIST version 1.1, or bone-only disease * Eastern Cooperative Oncology Group (ECOG) 0-2, and life expectancy ≥ 3 months * Adequate organ and marrow function * Resolution of all toxic effects of prior therapy or surgical procedures Exclusion Criteria: * Patients who have progressed within 2 years of adjuvant endocrine therapy * Patients who have not received prior endocrine therapy and are eligible to receive fulvestrant as initial therapy * Patients with advanced, symptomatic, visceral spread that are at risk of life threatening complication in the short term * Known uncontrolled or symptomatic central nervous system metastases * Diagnosis of any other malignancy within 3 years prior to randomization (except adequately treated basal or squamous cell skin cancer or cervical carcinoma in situ) * Serious uncontrolled intercurrent infections or intercurrent medical or psychiatric illness

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

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

Breast cancer

Contacts and locations

Locations

  • State Key Laboratory of Oncology in South China, Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong, 510060, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.