RecruitingPhase 2interventionalRules rewrite

Phase 2: testing Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab for Advanced HER2-positive Breast Cancer

This study is a randomly assigned, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the how well it works 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.

Official registry: https://clinicaltrials.gov/study/NCT07581795 · Fudan University · enrollment listed as 140

What this phase means

Phase 2: researchers already know a roughly safe dose (from phase 1). This stage asks whether the treatment actually helps the condition, and watches side effects more closely.

Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

What the registry says happens

If you join, the listed intervention(s) are Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab, or Taxanes combined with trastuzumab and pertuzumab.. The registry lists allocation as randomized. This study is a randomly assigned, open-label, controlled, multicenter Phase II trial conducted in patients with advanced HER2-positive breast cancer, aimed at evaluating the how well it works 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.

They plan to enroll about 140 people at Shanghai. Taking part typically means taking a study drug (or dummy pill) plus check-ins.

Official title (unrewritten)

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

Interventions: Paclitaxel polymer micelles combined with trastuzumab, pertuzumab, and adrelumab, Taxanes combined with trastuzumab and pertuzumab.

Primary outcome (registry wording): Objective response rate （ORR）

Who it is for (from inclusion criteria)

Ages 18 Years to any
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+);
PD-L1 testing is positive (combined positive score CPS ≥ 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;

Who the registry excludes

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;

Public study contact (from the registry)

Jian Zhang

+8618017312991

syner2000@163.com

Published on ClinicalTrials.gov. Contact them as a possible participant. They decide eligibility.

Sites listed on ClinicalTrials.gov

1 listed

Fudan University Shanghai Cancer center — Shanghai, Shanghai Municipality, China (recruiting)

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FAQ about this NCT record

Is NCT07581795 still recruiting?

The sponsor posted status “Recruiting” on ClinicalTrials.gov at last ingest. Sites can pause independently. Confirm with the official record and the listed contact.

What phase is NCT07581795?

Phase 2. Phase labels are FDA/ICH categories applied to the registry Phase field. They are not a finding that this study succeeded.

Can PlainTrials tell me if I qualify for NCT07581795?

No. The inclusion and exclusion lists on this page are readable extracts of the public eligibility block. Only the study team can screen you.

How to read a ClinicalTrials.gov record · Questions to ask the coordinator · Glossary