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New combo therapy aims to beat back aggressive breast cancer

NCT ID NCT05909332

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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

Summary

This phase 3 trial tests whether adding an anti-vascular drug to standard chemotherapy can help prevent cancer from returning in people with a specific, aggressive type of triple-negative breast cancer. About 764 women with stage II to III cancer will receive either the combination or chemo alone. The study measures how long participants live without their cancer coming back.

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 764 people

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

Started

Jun 2023

Expected to finish

May 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: * Women aged 18-70 years old; * Eastern Oncology Collaborative Group (ECOG) physical status score: 0 or 1; * Histological results recorded as TNBC (negative HER2, ER, and PgR status) and BLIS subtype according to the classification of FUSCC; * Have stage IIA-IIIIC triple-negative breast cancer with non-metastatic surgically treated: pT1-3N1-3M0; * Adequate hematological and end-organ function as defined by the following laboratory test results, which need to be completed within 28 days prior to the first study treatment: absolute neutrophil count (ANC) ≥ 1500 cells/μL (no G-CSF support therapy within 2 weeks prior to day 1 of course 1); Platelet count ≥ 75×109/L (no platelet transfusion within 2 weeks before day 1 of course 1); hemoglobin ≥ 9.0 g/dL (no RBC transfusion within 2 weeks before day 1 of course 1); AST, ALT, and alkaline phosphatase ≤ 3 × upper limit of normal (ULN) serum total bilirubin ≤ 1.0 × ULN; serum creatinine ≤ 1ULN and with an endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula); * The surgical incision had fully healed prior to the commencement of the study; * Female participants of reproductive potential are required to use a medically accepted form of contraception during the course of the study treatment and for at least three months following the last administration of the investigational drug; * Sign the Informed Consent Form (ICF). The patient is judged by the investigator to have the ability to comply with the provisions of the protocol. Exclusion Criteria: * Has received neoadjuvant therapy (including chemotherapy, targeted therapy, and radiotherapy) * Has bilateral breast cancer; * Has a previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ. * Has metastatic (Stage 4) breast cancer; * Has any \>T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer); * Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (a cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous to randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmgh, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; * Is pregnant, breastfeeding women, or women of childbearing age who cannot practice effective contraceptives; * Patients participating in other clinical trials at the same time; * Has known allergy to taxane and excipients. * Has severe or uncontrolled infection; * Has a history of psychotropic substance abuse and was unable to abandon drug habits or those with a history of mental disorders; * the researchers judged patients to be unsuitable for the study.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm triple-negative breast carcinoma

As listed by the trial registrant

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

Breast cancer Triple-negative 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

    15 sites. 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

  • Affiliated Hospital of Nantong University

    RECRUITING

    Nantong, Jiangsu, 226006, China

  • Beijing Cancer Hospital

    RECRUITING

    Beijing, Beijing Municipality, 100142, China

  • Breast cancer institute of Fudan University Cancer Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 200032, China

  • Chongqing Cancer Hospital

    RECRUITING

    Chongqing, Chongqing Municipality, 400030, China

  • Fujian Medical University Union Hospital

    RECRUITING

    Fuzhou, Fujian, 350001, China

  • Guangdong Academy of Medical Sciences Guangdong Provincial People's Hospital

    RECRUITING

    Guangzhou, Guangdong, China

  • Liaoning Cancer Hospital & Institute

    RECRUITING

    Shenyang, Liaoning, 110801, China

  • Ningbo Medical Center Lihuili Hospital

    RECRUITING

    Ningbo, Zhejiang, China

  • Northern Jiangsu People's Hospital

    RECRUITING

    Yangzhou, Jiangsu, 225009, China

  • Shanghai First Maternity and Infant Hospital

    RECRUITING

    Shanghai, Shanghai Municipality, 201204, China

  • Shanghai Sixth People's Hospital Affiliated to Shanghai Jiaotong University

    RECRUITING

    Shanghai, Shanghai Municipality, 200233, China

  • Sun Yat-sen University Cancer Center

    RECRUITING

    Guangdong, Guangzhou, 510062, China

  • The First Affiliated Hospital of Xi'an Jiaotong University

    RECRUITING

    Xi’an, Shanxi, 710061, China

  • The First Hospital of China Medical University

    RECRUITING

    Shenyang, Liaoning, 110002, China

  • West China Hospital of Sichuan University

    RECRUITING

    Chengdu, Sichuan, 610041, China

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