Advanced HER2-positive Breast CancerPhase 2SPECTACLENCT07581795
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 Phase 2 study testing Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab and Taxanes combined with trastuzumab and pertuzumab. in people with Advanced HER2-positive Breast Cancer, run by Fudan University at 1 site in China.
Trial 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… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Advanced HER2-positive Breast Cancer
- What is being tested?
- Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab and Taxanes combined with trastuzumab and pertuzumab.
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- 28 Jul 2026to 31 Mar 2031
- Phase
- Phase 2
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
None listed.
Who cannot join
- 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.);
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- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
Fudan University Shanghai Cancer center
Shanghai, Shanghai Municipality, 200032
Jian Zhang, +8618017312991, syner2000@163.com
Yiqun Du, +8618121299359, dyqlh2010@163.com
About this study
Official title: 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.
Read the detailed description
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.
- Conditions
- Advanced HER2-positive Breast Cancer
- Being tested
- Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab, Taxanes combined with trastuzumab and pertuzumab.
- Keywords
- Advanced breast cancer，HER2-positive，Paclitaxel Polymeric Micelles，Adebelimab
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumabDrug
- Paclitaxel polymer micelles for injection: 300 mg/m², administered via intravenous infusion over ≥3.5 hours;
- Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours;
- Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours;
- Adalimumab: 20 mg/kg, with infusion duration controlled between 30 to 60 minutes, not exceeding 2 hours.
Taxanes combined with trastuzumab and pertuzumab.Drug
- 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.
- Trastuzumab: Initial dose of 8 mg/kg, administered within 1.5 hours; subsequent doses adjusted to 6 mg/kg, administered within 1.5 hours;
- Pertuzumab: Initial dose of 840 mg, followed by a subsequent dose of 420 mg, administered via intravenous infusion within 1.5 hours;
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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; Receives: Drug: Taxanes combined with trastuzumab and pertuzumab. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From enrollment to the end of treatment up to approximately 24 months
Secondary outcomes (3)
Progression-Free Survival (PFS)
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.
Measured: From enrollment to the first evidence of PD or death from any cause up to approximately 24 months
Overall Survival (OS)
Time from date of randomization to the date of death from any cause
Measured: From enrollment to the date of death up to approximately 60 months
Safety Endpoints
Include adverse event profiles, incidence rates, dose reductions, treatment delays, and discontinuations due to adverse events.
Measured: From enrollment to the end of treatment up to approximately 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2026
- Study start28 Jul 2026
- Primary completion28 Feb 2029 (estimated)
- Study completion31 Mar 2031 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Advanced HER2-positive Breast CancerStudies of the same condition, open and under way.
- More trials run by Fudan UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Fudan University
- Sponsor type
- University, hospital or other
- Collaborators
- Nanchang Third Hospital, Anhui Provincial Hospital, Zhejiang Tumor Hospital
- Responsible party
- Principal investigator, Jian Zhang,MD, Fudan University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07581795
- Sponsor's protocol ID
- ZSCJSIITRX001
- Acronym
- SPECTACLE
- Status last verified
- May 2026
- First submitted
- 6 May 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.
PubMed 35576956Ahn HK, Sim SH, Suh KJ, Kim MH, Jeong JH, Kim JY, Lee DW, Ahn JH, Chae H, Lee KH, Kim JH, Lee KS, Sohn JH, Choi YL, Im SA, Jung KH, Park YH. Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1271-1277. doi: 10.1001/jamaoncol.2022.2310.
PubMed 35797012Schettini 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.
PubMed 34392185Janjigian 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.
PubMed 34912120Xu 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.
PubMed 36463547Thill M, Wimberger P, Grafe A, Klare P, Luedtke-Heckenkamp K, Reichert D, Zaiss M, Ziegler-Lohr K, Eckl T, Schneeweiss A. Dual HER2 blockade with pertuzumab (P) and trastuzumab (T) in patients with HER2-positive metastatic breast cancer (mBC) relapsing after adjuvant treatment with T: results from a German non-interventional study (NIS) HELENA (NCT01777958). Breast Cancer Res Treat. 2022 Nov;196(2):311-321. doi: 10.1007/s10549-022-06710-4. Epub 2022 Sep 12.
PubMed 36094611Swain 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.
PubMed 25693012Shi M, Gu A, Tu H, Huang C, Wang H, Yu Z, Wang X, Cao L, Shu Y, Wang H, Yang R, Li X, Chang J, Hu Y, Shen P, Hu Y, Guo Z, Tao M, Zhang Y, Liu X, Sun Q, Zhang X, Jiang Z, Zhao J, Chen F, Yu H, Zhang W, Sun J, Li D, Zhou J, Han B, Wu YL. Comparing nanoparticle polymeric micellar paclitaxel and solvent-based paclitaxel as first-line treatment of advanced non-small-cell lung cancer: an open-label, randomized, multicenter, phase III trial. Ann Oncol. 2021 Jan;32(1):85-96. doi: 10.1016/j.annonc.2020.10.479. Epub 2020 Oct 29.
PubMed 33130217Shi M, Sun J, Zhou J, Yu H, Yu S, Xia G, Wang L, Teng Y, Liu G, Yu C, Feng J, Shen Y. Phase I dose escalation and pharmacokinetic study on the nanoparticle formulation of polymeric micellar paclitaxel for injection in patients with advanced solid malignancies. Invest New Drugs. 2018 Apr;36(2):269-277. doi: 10.1007/s10637-017-0506-4. Epub 2017 Sep 4.
PubMed 28868573
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT07581795
- Acronym / sponsor ID
- SPECTACLE / ZSCJSIITRX001
- Conditions
- Advanced HER2-positive Breast Cancer
- Keywords
- Advanced breast cancer，HER2-positive，Paclitaxel Polymeric Micelles，Adebelimab
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Fudan UniversityUniversity, hospital or other
- Collaborators
- Nanchang Third Hospital, Anhui Provincial Hospital, Zhejiang Tumor Hospital
- Study start
- 28 Jul 2026 (actual)
- Primary completion
- 28 Feb 2029 (estimated)
- Study completion
- 31 Mar 2031 (estimated)
- First posted
- 12 May 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Paclitaxel Polymeric MicellEs Combined with Trastuzumab and Pertuzumab and Adebelimab | Experimental | Drug: Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab1. 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. |
| taxanes combined with trastuzumab and pertuzumab | Active comparator | Drug: 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; |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (0 listed)
Key exclusion criteria (15 listed)
- 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.);
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab1. 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 Polymeric MicellEs Combined with Trastuzumab and Pertuzumab and Adebelimab |
| 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; | Drug | taxanes combined with trastuzumab and pertuzumab |
Primary outcome
Objective response rate （ORR）
Time frame: 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.
3 secondary outcomes
Progression-Free Survival (PFS)
Time frame: From enrollment to the first evidence of PD or death from any cause up to approximately 24 months
Overall Survival (OS)
Time frame: From enrollment to the date of death up to approximately 60 months
Safety Endpoints
Time frame: From enrollment to the end of treatment up to approximately 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Nov 2026.
- Background: PubMed 35576956Wang J, Zhou C, Yao W, Wang Q, Min X, Chen G, Xu X, Li X, Xu F, Fang Y, Yang R, Yu G, Gong Y, Zhao J, Fan Y, Liu Q, Cao L, Yao Y, Liu Y, Li X, Wu J, He Z, Lu K, Jiang L, Hu C, Zhao W, Zhang B, Shi W, Zhang X, Cheng Y; CAPSTONE-1 Study Group. Adebrelimab or placebo plus carboplatin and etoposide as first-line treatment for extensive-stage small-cell lung cancer (CAPSTONE-1): a multicentre, randomised, double-blind, placebo-controlled, phase 3 trial. Lancet Oncol. 2022 Jun;23(6):739-747. doi: 10.1016/S1470-2045(22)00224-8. Epub 2022 May 13.
- Background: PubMed 35797012Ahn HK, Sim SH, Suh KJ, Kim MH, Jeong JH, Kim JY, Lee DW, Ahn JH, Chae H, Lee KH, Kim JH, Lee KS, Sohn JH, Choi YL, Im SA, Jung KH, Park YH. Response Rate and Safety of a Neoadjuvant Pertuzumab, Atezolizumab, Docetaxel, and Trastuzumab Regimen for Patients With ERBB2-Positive Stage II/III Breast Cancer: The Neo-PATH Phase 2 Nonrandomized Clinical Trial. JAMA Oncol. 2022 Sep 1;8(9):1271-1277. doi: 10.1001/jamaoncol.2022.2310.
- Background: PubMed 34392185Schettini 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.
- Background: PubMed 34912120Janjigian 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.
- Background: PubMed 36463547Xu 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.
- Background: PubMed 36094611Thill M, Wimberger P, Grafe A, Klare P, Luedtke-Heckenkamp K, Reichert D, Zaiss M, Ziegler-Lohr K, Eckl T, Schneeweiss A. Dual HER2 blockade with pertuzumab (P) and trastuzumab (T) in patients with HER2-positive metastatic breast cancer (mBC) relapsing after adjuvant treatment with T: results from a German non-interventional study (NIS) HELENA (NCT01777958). Breast Cancer Res Treat. 2022 Nov;196(2):311-321. doi: 10.1007/s10549-022-06710-4. Epub 2022 Sep 12.
- Background: PubMed 25693012Swain 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.
- Background: PubMed 33130217Shi M, Gu A, Tu H, Huang C, Wang H, Yu Z, Wang X, Cao L, Shu Y, Wang H, Yang R, Li X, Chang J, Hu Y, Shen P, Hu Y, Guo Z, Tao M, Zhang Y, Liu X, Sun Q, Zhang X, Jiang Z, Zhao J, Chen F, Yu H, Zhang W, Sun J, Li D, Zhou J, Han B, Wu YL. Comparing nanoparticle polymeric micellar paclitaxel and solvent-based paclitaxel as first-line treatment of advanced non-small-cell lung cancer: an open-label, randomized, multicenter, phase III trial. Ann Oncol. 2021 Jan;32(1):85-96. doi: 10.1016/j.annonc.2020.10.479. Epub 2020 Oct 29.
- Background: PubMed 28868573Shi M, Sun J, Zhou J, Yu H, Yu S, Xia G, Wang L, Teng Y, Liu G, Yu C, Feng J, Shen Y. Phase I dose escalation and pharmacokinetic study on the nanoparticle formulation of polymeric micellar paclitaxel for injection in patients with advanced solid malignancies. Invest New Drugs. 2018 Apr;36(2):269-277. doi: 10.1007/s10637-017-0506-4. Epub 2017 Sep 4.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab and Taxanes combined with trastuzumab and pertuzumab. in people with Advanced HER2-positive Breast Cancer, run by Fudan University at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 0 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jian Zhang (+8618017312991, syner2000@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Objective response rate （ORR） (time frame: From enrollment to the end of treatment up to approximately 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07581795, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Nov 2026.