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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 (SPECTACLE)

6 maggio 2026 aggiornato da: Jian Zhang,MD, Fudan University

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

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.

Panoramica dello studio

Stato

Non ancora reclutamento

Condizioni

Intervento / Trattamento

Descrizione dettagliata

In 2020, the incidence rate of breast cancer among women in China was 59.0 per 100,000, with a mortality rate of 16.6 per 100,000, ranking first and fourth, respectively, among all female malignant tumors nationwide. Currently, for the salvage treatment of human epidermal growth factor receptor 2-positive (HER2+) breast cancer (BC), the first-line recommended regimen is trastuzumab combined with pertuzumab plus a taxane-based therapy.

Paclitaxel is a broad-spectrum anticancer agent with a unique mechanism of action, exhibiting significant antitumor activity against various malignant tumors, including breast cancer, lung cancer, ovarian cancer, esophageal cancer, gastric cancer, and head and neck cancer. It is widely used in clinical practice for the treatment of these malignancies. Among its formulations, the paclitaxel injection solubilized with polyoxyethylene castor oil was the first to be approved for market. However, polyoxyethylene castor oil can induce human serum complement activation and histamine release, leading to adverse reactions such as renal impairment, neurotoxicity, bone marrow suppression, allergic reactions, and asymptomatic arrhythmias. To prevent allergic reactions, prophylactic medication is required prior to administration; nevertheless, some patients may still experience varying degrees of allergic reactions, causing clinical operational challenges and patient discomfort. Globally, an increasing number of research institutions are dedicated to developing novel paclitaxel formulations aimed at reducing its adverse effects, increasing its clinical dosage, and enhancing its therapeutic efficacy.

Paclitaxel polymer micelles for injection is an innovative paclitaxel dosage form independently developed by China Shanghai Yizhong Pharmaceutical Co., Ltd. This formulation exhibits exceptional in vivo stability and high sensitivity in intratumoral drug release. Compared to other marketed paclitaxel formulations, paclitaxel micelles demonstrate superior safety even with significantly higher clinical dosages, require no antiallergic pretreatment prior to administration, and eliminate the need for specialized infusion devices, ensuring clinical convenience. Phase III clinical trial results for non-small cell lung cancer (NSCLC) demonstrated a markedly improved objective response rate (ORR) and significantly prolonged progression-free survival (PFS). In first-line treatment of advanced NSCLC, it exhibits unique advantages and advanced efficacy in both therapeutic outcomes and safety profiles, making it a novel option for NSCLC chemotherapy.

Studies have demonstrated that PD-L1 expression can be detected in approximately 42% of HER2-positive breast cancer patients. Results from a Phase II clinical trial showed that the overall pathological complete response (pCR) rate reached 61% when immune checkpoint inhibitors were added to the treatment of HER2-positive breast cancer, with even higher pCR rates observed in subgroup analyses. These findings collectively suggest that targeting PD-1/PD-L1 holds promise as a potential therapeutic target for HER2-positive breast cancer. Adecabtagalimab, a humanized anti-PD-L1 monoclonal antibody, specifically binds to the PD-L1 molecule to block the PD-1/PD-L1 pathway responsible for tumor immune tolerance, thereby reactivating the immune system's antitumor activity and achieving therapeutic effects. In March 2023, the National Medical Products Administration approved adecabtagalimab in combination with carboplatin and etoposide for first-line treatment of patients with extensive-stage small cell lung cancer.

Based on previous research findings and the widespread application of paclitaxel in breast cancer treatment, this study aims to develop a clinical protocol comparing paclitaxel polymer micelles for injection combined with dupilumab and adalimumab versus taxane-based regimens combined with dupilumab as first-line therapy for unresectable advanced HER2-positive breast cancer. The goal is to demonstrate that the combination of paclitaxel polymer micelles with dupilumab and adalimumab provides therapeutic benefits in patients with advanced HER2-positive breast cancer while maintaining manageable safety profiles. The primary objective of the study is to evaluate the objective response rate (ORR) between the trial group (paclitaxel polymer micelles + dupilumab + adalimumab) and the control group (taxanes + dupilumab) in first-line treatment of advanced HER2-positive breast cancer. The secondary objectives are to assess progression-free survival (PFS), overall survival (OS), and safety profiles of the trial group versus the control group in this context.

Tipo di studio

Interventistico

Iscrizione (Stimato)

140

Fase

  • Fase 2

Contatti e Sedi

Questa sezione fornisce i recapiti di coloro che conducono lo studio e informazioni su dove viene condotto lo studio.

Contatto studio

Luoghi di studio

  • Cina
    • Shanghai Municipality
      • Shanghai, Shanghai Municipality, Cina, 200032
        • Fudan University Shanghai Cancer Center
        • Investigatore principale:
          • Jian Zhang
        • Contatto:
        • Contatto:
        • Investigatore principale:
          • Yiqun Du

Criteri di partecipazione

I ricercatori cercano persone che corrispondano a una certa descrizione, chiamata criteri di ammissibilità. Alcuni esempi di questi criteri sono le condizioni generali di salute di una persona o trattamenti precedenti.

Criteri di ammissibilità

Età idonea allo studio

  • Adulto
  • Adulto più anziano

Accetta volontari sani

No

Descrizione

  1. Age: ≥18 years, no gender restriction;
  2. Pathologically confirmed breast cancer: a) Advanced or metastatic breast cancer; b) Locally assessed as HER2-positive (IHC 3+ or IHC 2+ with ISH+);
  3. 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;
  4. PD-L1 testing is positive (combined positive score CPS ≥ 1);
  5. ECOG score is 0-1;
  6. Estimated survival is at least 3 months;
  7. There is at least one measurable lesion assessed by computed tomography (CT) and/or magnetic resonance imaging (MRI) (according to RECIST 1.1);
  8. Basic normal function of major organs such as the heart, lungs, liver, and kidneys;
  9. 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);
  10. Patients voluntarily participate in the study, sign an informed consent form, and demonstrate good compliance.

Exclusion Criteria:

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

  1. Known allergy or intolerance to any study agent or excipient;
  2. 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;
  3. 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;
  4. 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;
  5. 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.);
  6. History of live vaccine vaccination within 28 days prior to treatment;
  7. 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;
  8. Patients with significant coagulation disorders or other clear evidence of bleeding risk.
  9. 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);
  10. Patients with active hepatitis B or C virus infection, HIV infection, or active pulmonary tuberculosis;
  11. Patients with active infections requiring antimicrobial therapy (e.g., antibiotics, antiviral agents, or antifungal drugs);
  12. Patients with a known history of allogeneic organ transplantation or hematopoietic stem cell transplantation;
  13. Patients with a history of substance abuse (e.g., psychiatric medications) that cannot be discontinued or those with mental disorders;
  14. Pregnant or breastfeeding women; or patients of reproductive age who are unwilling or unable to use effective contraceptive measures.

Piano di studio

Questa sezione fornisce i dettagli del piano di studio, compreso il modo in cui lo studio è progettato e ciò che lo studio sta misurando.

Come è strutturato lo studio?

Dettagli di progettazione

  • Scopo principale: Trattamento
  • Assegnazione: Randomizzato
  • Modello interventistico: Assegnazione parallela
  • Mascheramento: Nessuno (etichetta aperta)

Armi e interventi

Gruppo di partecipanti / Arm
Intervento / Trattamento
Sperimentale: Paclitaxel Polymeric MicellEs Combined with Trastuzumab and Pertuzumab and Adebelimab
  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.
Droga: Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab
  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.
Comparatore attivo: taxanes combined with trastuzumab and pertuzumab
  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;
Droga: Taxanes combined with trastuzumab and pertuzumab.
  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;

Cosa sta misurando lo studio?

Misure di risultato primarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Objective response rate （ORR）
Lasso di tempo: From enrollment to the end of treatment up to approximately 24 months
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

Misure di risultato secondarie

Misura del risultato
Misura Descrizione
Lasso di tempo
Progression-Free Survival (PFS)
Lasso di tempo: From enrollment to the first evidence of PD or death from any cause up to approximately 24 months
PFS defined as the time from the date of randomization to the first evidence of disease progression as defined by response evaluation criteria in solid tumors (RECIST) v1.1 or death from any cause. Progressive Disease (PD) was at least a 20% increase in the sum of the diameters of target lesions, with reference being the smallest sum on study and an absolute increase of at least 5 mm, or unequivocal progression of non-target lesions, or 1 or more new lesions. If a participant does not have a complete baseline disease assessment, then the PFS time was censored at the date of randomization, regardless of whether or not objectively determined disease progression or death has been observed for the participant. If a participant was not known to have died or have objective progression as of the data inclusion cutoff date for the analysis, the PFS time was censored at the last adequate tumor assessment date.
From enrollment to the first evidence of PD or death from any cause up to approximately 24 months
Overall Survival (OS)
Lasso di tempo: From enrollment to the date of death up to approximately 60 months
Time from date of randomization to the date of death from any cause
From enrollment to the date of death up to approximately 60 months
Safety Endpoints
Lasso di tempo: From enrollment to the end of treatment up to approximately 24 months
Include adverse event profiles, incidence rates, dose reductions, treatment delays, and discontinuations due to adverse events.
From enrollment to the end of treatment up to approximately 24 months

Collaboratori e investigatori

Qui è dove troverai le persone e le organizzazioni coinvolte in questo studio.

Sponsor

Fudan University

Collaboratori

Anhui Provincial Hospital
Zhejiang Tumor Hospital
Nanchang People's Hospital

Pubblicazioni e link utili

La persona responsabile dell'inserimento delle informazioni sullo studio fornisce volontariamente queste pubblicazioni. Questi possono riguardare qualsiasi cosa relativa allo studio.

Pubblicazioni generali

Studiare le date dei record

Queste date tengono traccia dell'avanzamento della registrazione dello studio e dell'invio dei risultati di sintesi a ClinicalTrials.gov. I record degli studi e i risultati riportati vengono esaminati dalla National Library of Medicine (NLM) per assicurarsi che soddisfino specifici standard di controllo della qualità prima di essere pubblicati sul sito Web pubblico.

Studia le date principali

Inizio studio (Stimato)

1 giugno 2026

Completamento primario (Stimato)

1 febbraio 2029

Completamento dello studio (Stimato)

1 marzo 2031

Date di iscrizione allo studio

Primo inviato

6 maggio 2026

Primo inviato che soddisfa i criteri di controllo qualità

6 maggio 2026

Primo Inserito (Effettivo)

12 maggio 2026

Aggiornamenti dei record di studio

Ultimo aggiornamento pubblicato (Effettivo)

12 maggio 2026

Ultimo aggiornamento inviato che soddisfa i criteri QC

6 maggio 2026

Ultimo verificato

1 maggio 2026

Maggiori informazioni

Termini relativi a questo studio

Parole chiave

Termini MeSH pertinenti aggiuntivi

Altri numeri di identificazione dello studio

  • ZSCJSIITRX001

Piano per i dati dei singoli partecipanti (IPD)

Hai intenzione di condividere i dati dei singoli partecipanti (IPD)?

NO

Informazioni su farmaci e dispositivi, documenti di studio

Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti

No

Studia un dispositivo regolamentato dalla FDA degli Stati Uniti

No

prodotto fabbricato ed esportato dagli Stati Uniti

No

Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .

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