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

NCT07581795 | Not Yet Recruiting Phase 2

• 1 other identifier: ZSCJSIITRX001
• Study Type: interventional
• Target: 140
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Advanced HER2-positive Breast Cancer

Keywords

Advanced breast cancer，HER2-positive，Paclitaxel Polymeric Micelles，Adebelimab

Outcome Measures

Primary Outcomes (1)

• Objective response rate （ORR）

  Objective Response Rate (ORR): Proportion of patients with best overall response of complete response (CR) or partial response (PR) according to RECIST 1.1 criteria.

  From enrollment to the end of treatment up to approximately 24 months

Secondary Outcomes (3)

• Progression-Free Survival (PFS)

  From enrollment to the first evidence of PD or death from any cause up to approximately 24 months

• Overall Survival (OS)

  From enrollment to the date of death up to approximately 60 months

• Safety Endpoints

  From enrollment to the end of treatment up to approximately 24 months

Study Arms (2)

Paclitaxel Polymeric MicellEs Combined with Trastuzumab and Pertuzumab and Adebelimab

EXPERIMENTAL

1. Paclitaxel polymer micelles for injection: 300 mg/m², administered via intravenous infusion over ≥3.5 hours; 2. Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours; 3. Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours; 4. Adalimumab: 20 mg/kg, with infusion duration controlled between 30 to 60 minutes, not exceeding 2 hours.

Drug: Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab

taxanes combined with trastuzumab and pertuzumab

ACTIVE COMPARATOR

1. Paclitaxel: 175 mg/m², intravenous infusion over 3 hours; or Docetaxel: 75 mg/m², intravenous infusion over 1 hour; or Albumin-bound paclitaxel: 260 mg/m², intravenous infusion over 30 minutes; or Paclitaxel polymer micelles for injection: 300 mg/m², intravenous infusion over ≥3.5 hours. 2. Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours; 3. Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours;

Drug: Taxanes combined with trastuzumab and pertuzumab.

Interventions

Taxanes combined with trastuzumab and pertuzumab. DRUG

1. Paclitaxel: 175 mg/m², intravenous infusion over 3 hours; or Docetaxel: 75 mg/m², intravenous infusion over 1 hour; or Albumin-bound paclitaxel: 260 mg/m², intravenous infusion over 30 minutes; or Paclitaxel polymer micelles for injection: 300 mg/m², intravenous infusion over ≥3.5 hours. 2. Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours; 3. Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours;

taxanes combined with trastuzumab and pertuzumab

Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab DRUG

1. Paclitaxel polymer micelles for injection: 300 mg/m², administered via intravenous infusion over ≥3.5 hours; 2. Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours; 3. Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours; 4. Adalimumab: 20 mg/kg, with infusion duration controlled between 30 to 60 minutes, not exceeding 2 hours.

Paclitaxel Polymeric MicellEs Combined with Trastuzumab and Pertuzumab and Adebelimab

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Subjects were ineligible for this trial if they met any of the following criteria:
• 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 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 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.);
• History of live vaccine vaccination within 28 days prior to treatment;
• 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 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);
• 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;
• Pregnant or breastfeeding women; or patients of reproductive age who are unwilling or unable to use effective contraceptive measures.

Sponsors & Collaborators

• Fudan University: lead
• Nanchang People's Hospital: collaborator
• Anhui Provincial Hospital: collaborator
• Zhejiang Tumor Hospital: collaborator

Study Sites (1)

Fudan University Shanghai Cancer center

Shanghai, Shanghai Municipality, 200032, China

Location

Related Publications (9)

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• Schettini F, Prat A. Dissecting the biological heterogeneity of HER2-positive breast cancer. Breast. 2021 Oct;59:339-350. doi: 10.1016/j.breast.2021.07.019. Epub 2021 Aug 5.

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• Janjigian YY, Kawazoe A, Yanez P, Li N, Lonardi S, Kolesnik O, Barajas O, Bai Y, Shen L, Tang Y, Wyrwicz LS, Xu J, Shitara K, Qin S, Van Cutsem E, Tabernero J, Li L, Shah S, Bhagia P, Chung HC. The KEYNOTE-811 trial of dual PD-1 and HER2 blockade in HER2-positive gastric cancer. Nature. 2021 Dec;600(7890):727-730. doi: 10.1038/s41586-021-04161-3. Epub 2021 Dec 15.

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• Xu B, Li W, Zhang Q, Li Q, Wang X, Li H, Sun T, Yin Y, Zheng H, Feng J, Zhu H, Siddiqui A, Macharia H, Knott A. Pertuzumab, trastuzumab, and docetaxel for Chinese patients with previously untreated HER2-positive locally recurrent or metastatic breast cancer (PUFFIN): final analysis of a phase III, randomized, double-blind, placebo-controlled study. Breast Cancer Res Treat. 2023 Feb;197(3):503-513. doi: 10.1007/s10549-022-06775-1. Epub 2022 Dec 4.

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• Swain SM, Baselga J, Kim SB, Ro J, Semiglazov V, Campone M, Ciruelos E, Ferrero JM, Schneeweiss A, Heeson S, Clark E, Ross G, Benyunes MC, Cortes J; CLEOPATRA Study Group. Pertuzumab, trastuzumab, and docetaxel in HER2-positive metastatic breast cancer. N Engl J Med. 2015 Feb 19;372(8):724-34. doi: 10.1056/NEJMoa1413513.

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  PMID: 28868573 BACKGROUND

MeSH Terms

Interventions

Trastuzumab; pertuzumab

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins

Central Study Contacts

Jian Zhang

CONTACT

+8618017312991; syner2000@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Phase I Unit，Chief physician of oncology department

Study Record Dates

• First Submitted: May 6, 2026
• First Posted: May 12, 2026
• Study Start: June 1, 2026
• Primary Completion (Estimated): February 1, 2029
• Study Completion (Estimated): March 1, 2031
• Last Updated: May 12, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)