NCT07581795RecruitingPhase 2

Study of Paclitaxel Polymeric Micelles Combined With HP and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer

A Multicenter, Randomized, Open-Label, Controlled Phase II Clinical Study of Paclitaxel Polymeric Micelles Combined With Trastuzumab and Pertuzumab (HP) and Adebelimab Versus Taxane Combined With HP as First-Line Treatment for Advanced HER2-Positive Breast Cancer

Source: ClinicalTrials.gov · Last updated 2 Nov 2026

Brief summary (registry, in English)

This study is a randomized, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the efficacy and safety of paclitaxel polymer micelles for injection combined with trastuzumab and adalimumab versus the paclitaxel-based regimen combined with trastuzumab as first-line treatment. Eligible subjects with histologically or cytologically confirmed advanced HER2-positive breast cancer were enrolled after obtaining informed consent. They were randomly assigned to two groups: the experimental group received paclitaxel polymer micelles for injection combined with trastuzumab, pertuzumab, and adrelumab; the control group received taxanes (paclitaxel, docetaxel, albumin-bound paclitaxel, paclitaxel polymer micelles) combined with trastuzumab and pertuzumab. Each treatment cycle lasted 3 weeks (Q3W), with administration on day 1 (D1) of each cycle. Therapy continued until disease progression (PD), intolerable toxicity, withdrawal of informed consent, initiation of alternative antitumor therapy, death, or any other treatment discontinuation criteria specified in the protocol-whichever occurred first.

Status (registry): Recruiting
Phase (registry): Phase 2
Study type: Interventional
Enrollment: 140 (estimated)
First submitted: 6 May 2026
Start date: 28 Jul 2026
Primary completion date: 28 Feb 2029
Lead sponsor: Fudan University
Diseases: Metastatic breast cancer
NCT number: NCT07581795

What you commit to

Study type: Interventional · Phase 2
Planned participants: 140
From 28 Jul 2026 to the primary completion date, 28 Feb 2029
1 site in 1 country
Visits and tests: ask the trial team, the registry does not list them

Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.

Who cannot take part

Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.

Prior treatment

History of chemotherapy, targeted therapy, or major surgery within 4 weeks prior to first dose; history of endocrine therapy or local radiotherapy within 2 weeks prior to first dose;
Active or previously documented interstitial lung disease (ILD), pneumonia, or suspected ILD that could not be excluded by imaging during screening; pneumonia that could not be excluded by imaging during screening;
History of live vaccine vaccination within 28 days prior to treatment;

Other illness

Known allergy or intolerance to any study agent or excipient;
Primary central nervous system malignancy or meningeal metastasis; symptomatic patients with central nervous system metastases; patients with asymptomatic brain metastases or clinically stable conditions requiring no steroid therapy for at least 4 weeks were eligible;
History of other malignancies within 5 years that could be locally treated and cured (excluding basal cell carcinoma of the skin, superficial or non-invasive bladder cancer, cervical carcinoma in situ, breast ductal carcinoma in situ, papillary thyroid carcinoma, etc.);
Active autoimmune diseases (including but not limited to myasthenia gravis, myositis, asthma, autoimmune hepatitis, systemic lupus erythematosus, rheumatoid arthritis, inflammatory bowel disease, antiphospholipid antibody syndrome, Wegener's granulomatosis, Sjögren's syndrome, Guillain-Barré syndrome, multiple sclerosis, vitiligo, psoriasis, etc.); stable-dose hormone replacement therapy for hypothyroidism was excluded;
Patients with significant coagulation disorders or other clear evidence of bleeding risk.
Patients with active hepatitis B or C virus infection, HIV infection, or active pulmonary tuberculosis;
Patients with active infections requiring antimicrobial therapy (e.g., antibiotics, antiviral agents, or antifungal drugs);
Patients with a known history of allogeneic organ transplantation or hematopoietic stem cell transplantation;
Patients with a history of substance abuse (e.g., psychiatric medications) that cannot be discontinued or those with mental disorders;

Lab values

Patients with the following cardiac conditions within 6 months prior to treatment initiation: acute coronary syndrome, coronary artery bypass grafting, congestive heart failure, aortic dissection, stroke, or other grade 3 or higher cardiovascular events; cardiac dysfunction classified ≥ Class II on the New York Heart Association (NYHA) scale or left ventricular ejection fraction (LVEF) \<50%; myocardial infarction, severe/unstable angina, cerebrovascular accident/stroke, transient ischemic attack, subarachnoid hemorrhage, or severe cardiac rhythm/conductance abnormalities requiring clinical intervention (e.g., ventricular arrhythmias, second-to-third-degree atrioventricular block, congenital long QT syndrome);

Age

Pregnant or breastfeeding women; or patients of reproductive age who are unwilling or unable to use effective contraceptive measures.

Other

Subjects were ineligible for this trial if they met any of the following criteria:

Criteria the registry did not label

Age: ≥18 years, no gender restriction;
Pathologically confirmed breast cancer: a) Advanced or metastatic breast cancer; b) Locally assessed as HER2-positive (IHC 3+ or IHC 2+ with ISH+);
For advanced or metastatic breast cancer, patients should have not previously received chemotherapy or HER2-targeted therapy, or have received only first-line endocrine therapy. Subjects receiving chemotherapy or HER2-targeted therapy as neoadjuvant or adjuvant treatment are eligible if the interval from treatment completion to metastasis diagnosis exceeds 6 months;
PD-L1 testing is positive (combined positive score CPS ≥ 1);
ECOG score is 0-1;
Estimated survival is at least 3 months;
There is at least one measurable lesion assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) (according to RECIST 1.1);
Basic normal function of major organs such as the heart, lungs, liver, and kidneys;
Sufficient organ and bone marrow function, meeting the following criteria: (1) Complete blood count must meet: a) Hemoglobin (HB) ≥ 90 g/L; b) Absolute neutrophil count (ANC) ≥ 1.5×10⁹/L; c) Platelet count (PLT) ≥ 75×10⁹/L; (2) Biochemical tests must meet: a) Serum total bilirubin (TBIL) ≤ 1.5× upper limit of normal (ULN); b) ALT and AST ≤ 2.5× ULN; if liver metastases are present, ALT and AST ≤ 5× ULN; c) Cr ≤ 1.5× ULN or creatinine clearance (CCr) ≥ 60 mL/min (Cockcroft-Gault formula);
Patients voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance.

Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers

Full criteria on ClinicalTrials.gov

Sites (1)

Sites in registry order. Pick your city on the disease page to sort them by distance.

Site	City	Country	Site status
Fudan University Shanghai Cancer Center Coordinator of this site? Confirm its status	Shanghai	China	Recruiting

This page is information, not medical advice. Discuss any trial with your doctor.