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New combo therapy aims to wipe out breast cancer before surgery

NCT ID NCT05525767

Disease control Sponsor: Hebei Medical University Fourth Hospital 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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 27, 2026 · Updated 1 time

Summary

This study tests whether adding bevacizumab to standard chemotherapy before surgery can improve outcomes for people with early or locally advanced HER2-negative breast cancer. About 75 participants will receive the drug combination, and researchers will measure how many achieve a complete response (no cancer left in the breast tissue). The trial is currently recruiting.

What this could mean

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

Active substance
bevacizumab (a drug that blocks blood vessel growth to tumors) combined with chemotherapy
What this could lead to
If successful, this could show that adding bevacizumab to standard chemo before surgery improves the chance of eliminating all cancer cells in the breast at the time of surgery.
What could go wrong
This is a single-arm, phase 4 study with only 75 participants, so results may not apply broadly. Bevacizumab can cause side effects like high blood pressure, bleeding, or slow wound healing.

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 4

Runs after approval, following long-term safety and how well the treatment works in everyday use.

Participants

About 75 people

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

Started

Mar 2022

Expected to finish

Dec 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

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. Age ≥18 years old; 2. Signed the informed consent and volunteered to join the study with good compliance; 3, histopathologically confirmed HER2-negative invasive breast cancer (including triple-negative breast cancer; Or Luminal breast cancer, that is, ER/PR positive and HER2 negative) : * HER2 negative was defined as 0/1+ on standard IHC test; HER2/CEP17 ratio was less than 2.0 or HER2 gene copy number was less than 4. * ER positive and/or PR positive were defined as the proportion of positively stained tumor cells in all tumor cells ≥1%; 4\. According to the American Joint Committee on Cancer (AJCC) 8th edition TNM stage II-IIIC (T2-T4 plus any N, or any T plus N1-3, M0); 5\. The main organs function well and meet the following standards: A) Hemoglobin (HGB)≥90g/L; B) Neutrophil absolute value (NEUT)≥1.5×109/L; C) Platelet count (PLT)≥ 100×109/L; D) leukocyte ≥3.0×109/L; E) Total bilirubin \<1.5 ULN (upper limit of normal) F) Creatinine \< 1.5×ULN G) AST/ALT \< 1.5×ULN; 6\. Cardiac ultrasound: left ventricular ejection fraction (LVEF≥55%); 7\. The investigators determined that the patients were suitable for treatment with bevacizumab. Exclusion Criteria: 1. Stage IV (metastatic) breast cancer; 2. Received treatment for the disease, including chemotherapy, endocrine therapy, radiotherapy, immunotherapy, etc.; 3. Patients who are participating in other intervention studies; 4. Women with confirmed pregnancy or lactation; 5. According to the judgment of the investigator, the subjects have concomitant diseases that seriously endanger the safety of the subjects or affect the completion of the study, or the subjects think that there are other reasons that are not suitable for inclusion.

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Conditions

The condition(s) this trial relates to.

Her2-receptor negative breast cancer neoplasm

As listed by the trial registrant

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

Solid tumor

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

  • The Fourth Hospital of Hebei Medical University

    RECRUITING

    Shijiazhuang, Hebei, 050011, China

More trials for these conditions

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