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New pill combo could delay advanced breast cancer progression

NCT ID NCT07371910

Disease control Sponsor: Sun Yat-Sen Memorial Hospital of 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests whether a combination of two targeted pills (fluorizoparib and apatinib) works better than standard chemotherapy for people with a specific genetic type of advanced breast cancer (HRD-positive, HER2-negative). About 200 participants will be randomly assigned to either the pill combo or continued chemo. The goal is to see if the pills can delay cancer growth with fewer 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 3

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

Participants

About 200 people

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

Started

Jun 2024

Expected to finish

Mar 2031

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 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: * Female patients aged 18-70 years. Histologically confirmed HER2-negative metastatic breast cancer. Documented HRD-positive status (defined as BRCA1/2 mutation and/or HRD positive). HR+/HER2- patients must have received prior endocrine therapy for metastatic disease. Have received no more than 2 prior lines of chemotherapy or ADC therapy for metastatic disease. At least one measurable lesion per RECIST 1.1. ECOG performance status 0-2 and life expectancy ≥3 months. Adequate organ function (bone marrow, liver, renal, cardiac). Exclusion Criteria: * HR+/HER2- patients who have not received prior endocrine therapy for metastatic disease. Have not received any prior systemic therapy for metastatic breast cancer. Have received \>2 prior lines of chemotherapy or ADC therapy for metastatic disease. Known severe hypersensitivity to any component of the study drugs. Pregnant, lactating, or women of childbearing potential unwilling to use effective contraception. Uncontrolled or significant cardiovascular disease. Any other condition deemed inappropriate for the study by the investigato

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Conditions

The condition(s) this trial relates to.

breast carcinoma breast neoplasm Her2-receptor negative breast cancer hormone receptor-positive breast cancer

As listed by the trial registrant

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

HRD-positive/HER2-negative advanced breast cancer Metastatic breast cancer

Contacts and locations

Locations

  • Sun Yat-sen Memorial Hospital, Sun Yat-sen University

    Guangzhou, Guangdong, 510030, China

More trials for these conditions

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