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New hope for tough breast cancer: drug combo trial launches

NCT ID NCT07376629

Disease control Sponsor: Huabo Biopharm Co., Ltd. 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 This study
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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 27, 2026 · Last updated Jun 27, 2026

Summary

This study tests a new drug called HB0025 combined with chemotherapy (nab-paclitaxel) as a first treatment for people with advanced triple-negative breast cancer that cannot be removed by surgery. The goal is to see if the combination is safe and works better than chemotherapy alone. About 60 adults who have not had prior treatment for metastatic disease will take part.

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 60 people

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

Started

Aug 2025

Expected to finish

Jan 2027

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. Signed informed consent form 2. Metastatic or locally advanced, histologically documented TNBC (absence of HER2, ER, and PR expression) 3. No prior systemic therapy for inoperable locally advanced or metastatic TNBC 4. ECOG performance status of 0 or 1 5. Life expectancy ≥ 12 weeks 6. Measurable disease, as defined by RECIST v1.1 Exclusion Criteria: 1. History of severe allergic diseases, allergic history of serious drugs (including unlisted test drugs) or known allergic to any component of this test drug; 2. Previously received any antibody or inhibitor therapy targeting PD-1/PD-L1 or VEGF; 3. Uncontrollable or symptomatic central nervous system (CNS) metastasis; 4. Pregnancy or lactation; 5. Those who have active infection 6. Known history of allogeneic organ transplantation or allogeneic hematopoietic stem cell transplantation

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Conditions

The condition(s) this trial relates to.

triple-negative breast carcinoma

As listed by the trial registrant

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

TNBC

How to take part

Only the study team decides who joins. These are the ways to reach them.

  1. The places running it

    23 sites. The list below names each one and where it is.

  2. The official record

    The full official record for this study. This one lists no contact details, but it is the first place any would appear.

    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

  • Affiliated Hospital of Jining Medical University

    Jining, China

  • Anhui Provincial Hospital

    Hefei, China

  • Anyang Cancer Hospital

    Anyang, China

  • Fudan University Shanghai Cancer Center

    Shanghai, China

  • Fujian Cancer Hospital

    Fujian, China

  • Guangdong Provincial People's Hospital

    Guangdong, China

  • Harbin Medical University Cancer Hospital

    Harbin, China

  • Jiangsu Province Hospital

    Nanjing, China

  • Liaoning Cancer Hospital

    Shengyang, China

  • Linyi Cancer Hospital

    Linyi, China

  • Shandong Cancer Hospital

    Shandong, China

  • Shanxi Cancer Hospital

    Shanxi, China

  • Sichuan Cancer Hospital

    Chengdu, China

  • Sir Run Run Shaw Hospital, Zhejiang University School of Medicine

    Hangzhou, China

  • Sun Yat-sen University Cancer Center

    Guangzhou, China

  • The First Affiliated Hospital of Xiamen University

    Xiamen, China

  • The First Hospital of Jilin University

    Jilin City, China

  • The Second Affiliated Hospital of Soochow University

    Suzhou, China

  • The Second Affiliated Hospital of Xi'an Jiaotong University

    Xi'an, China

  • Tianjin Cancer Hospital

    Tianjing, China

  • Union Hospital, Tongji Medical College, Huazhong University of Science and Technology

    Wuhan, China

  • Xiangya Hospital Central South University

    Changsha, China

  • Xuzhou Central Hospital

    Xuzhou, China

More trials for these conditions

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