New drug cocktail aims to wipe out breast cancer before surgery
NCT ID NCT05558722
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
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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 Hide 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
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Other studies related to the condition(s) this trial covers.
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