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New drug cocktail aims to wipe out breast cancer before surgery

NCT ID NCT05558722

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 phase 2 trial tests whether adding an oral targeted drug called anlotinib to standard chemotherapy can better clear cancer from the breast and lymph nodes before surgery in people with early-stage HER2-negative breast cancer. The study enrolled 31 high-risk patients. The main goal is to see how many achieve a complete response, meaning no cancer remains in the removed tissue.

What this could mean

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

Active substance
Anlotinib (a targeted drug that blocks blood vessel growth) plus chemotherapy (albumin-bound paclitaxel, pirarubicin, cyclophosphamide)
What this could lead to
If successful, this combination could increase the chance of eliminating all cancer before surgery, potentially improving long-term outcomes for high-risk HER2-negative breast cancer patients.
What could go wrong
This is a small, early-phase study with only 31 participants and no comparison group. The added drug may cause more side effects, and results may not apply to all patients.

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

31 people

The number who actually took part.

Started

Dec 2022

Expected to finish

Jul 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 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: * All patients were HER2 negative, defi ned as immunohistochemistry of 0/1+, or if 2+, fluorescence in situ hybridisation showed no evidence of amplification of the HER2 gene. * Patients were required to have a palpable primary tumor at least 2.0 cm in diameter in the breast, as assessed by physical examination, ultrasound, or magnetic resonance imaging. And to be classified as having tumor stage T1c to T4, nodal stage N0 to N3, (if patients having tumor stage of T1c, the nodal stage should be N1-3) and metastasis stage M0 (II-III stage). * Other eligibility criteria adequate cardiac function (left ventricular ejection fraction within the normal institutional range, as assessed by multiple gated acquisition scan or echocardiogram), adequate bone marrow, hepatic, and renal function, and appropriate Eastern Cooperative Oncology Group (ECOG) performance status (0-1). * All patients provided written informed consent. Exclusion Criteria: * Previously received anti-angiogenesis targeted drug therapy. * patients have previous diagnosis of ischaemic heart disease, cerebrovascular disease, peripheral vascular disease, arterial or venous thromboembolic disease, cardiac failure, gastroduodenal ulcer, symptomatic diverticulitis, or inflammatory bowel disease. * Previously received chemotherapy, radiotherapy, or endocrine therapy as treatment for breast cancer was allowed. * No uncontrolled hypertension.

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • Xijing Hospital Affiliated to Air Force Military Medical University

    Xi'an, Shannxi Province, 710032, China

More trials for these conditions

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