Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens
Official title: A Randomized, Multicenter, Open-label Clinical Study Using Peripheral Blood Circulating Tumor DNA to Evaluate the Efficacy of Preoperative Treatment With Pyrotinib + Trastuzumab + Docetaxel Versus Pertuzumab + Trastuzumab + Docetaxel in Early or Locally Advanced HER2-positive Breast Cancer
Run by Shanghai Jiao Tong University School of Medicine · NCT07335081 · Data updated 2026-11-12
We will test whether two different pre-surgery drug combinations clear tumor DNA from the blood better in people with HER2-positive early breast cancer.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 60 (estimated) |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, pyrotinib |
| Locations | 1 site (Shanghai) |
| Status | Recruiting |
| Started | February 1, 2024 |
| Main results expected | December 31, 2025 |
| Study ends | December 31, 2026 |
| Registry record updated | March 24, 2026 |
| Trial ID | NCT07335081 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are adults with histologically confirmed Stage II–III HER2-positive breast cancer (primary tumor >2 cm), ECOG 0–1, intact organ and cardiac function (LVEF ≥55%), and no prior cancer treatment.
✕Probably not a fit
Patients with bilateral or metastatic disease, a history of other malignancies, severe cardiovascular disease, or allergies to the study drugs are unlikely to benefit or be eligible.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This is a randomized, open-label Phase 2 study enrolling patients with early or locally advanced (T≥2 cm, N0-3, M0) HER2-positive breast cancer who have not received prior treatment. Participants are randomly assigned to receive either pyrotinib + trastuzumab + docetaxel or pertuzumab + trastuzumab + docetaxel for one course, with ctDNA measured in peripheral blood to compare clearance between arms. All participants receive a total of four courses of neoadjuvant therapy to evaluate overall therapeutic effectiveness and clinical response. Cardiac function and standard labs are monitored throughout treatment to ensure safety.
Why it matters
Potential benefit: If successful, this approach could help identify the more effective pre-surgery HER2 regimen and use ctDNA clearance as an early sign of treatment response.
How similar studies have gone: Previous studies have used ctDNA to monitor breast cancer response, but direct comparison of pyrotinib-containing versus pertuzumab-containing neoadjuvant regimens using ctDNA is limited and relatively novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
Inclusion Criteria: * histologically diagnosed with Stage II-III HER2+ breast cancer (primary diameter \>2cm) * Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1 * Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography * No prior treatment Exclusion Criteria: * Bilateral or metastatic breast cancer * History of other malignancies * Severe cardiovascular disease * Allergic to any of the regimens
Where it's running
-
Ruijin Hospital
Shanghai, China Recruiting
Study contacts
- Study coordinator: Haoyu Wang
- Email: meredithwhy@163.com
- Phone: 86 18817865256
Similar studies
Other studies for the same condition or treatment. Recruiting studies are listed first.
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Combination treatment for HR+/HER2+ breast cancer
This study is testing a new combination treatment for patients with stage II-III HR+/HER2+ breast cancer to see if it works better than the standard treatment before surgery.
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Neoadjuvant Pyrotinib-to-pertuzumab for HER2-positive early breast cancer
This trial tests whether a two-step neoadjuvant plan with Pyrotinib plus Trastuzumab and Docetaxel followed by Pertuzumab plus Trastuzumab and Docetaxel works better than four cycles of Pertuzumab plus Trastuzumab and Docetaxel in women with HER2-positive early- to locally advanced breast cancer.
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Entinostat with Pyrotinib and Endocrine Therapy in HER2-positive, HR-positive Advanced Breast Cancer after Trastuzumab Failure
This study tests whether adding entinostat to pyrotinib and hormone therapy is safe and helps patients with advanced HR+/HER2+ breast cancer who progressed after trastuzumab.
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Pyrotinib and Trastuzumab with Dalpiciclib vs with Docetaxel in advanced HER2-positive breast cancer
This study tests whether an oral regimen of pyrotinib + subcutaneous trastuzumab + dalpiciclib works as well as the standard IV regimen with docetaxel in people with advanced HER2-positive breast cancer who have limited prior treatment.
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Pre-surgery trastuzumab deruxtecan (SHR-A1811) plus pertuzumab for HER2-positive breast cancer
This trial tests giving trastuzumab deruxtecan (SHR-A1811) with pertuzumab before surgery to see if it helps women with stage II–III HER2-positive breast cancer achieve a complete response.
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Intensified HER2-targeted treatment for people with a suboptimal response to initial dual HER2 therapy and chemotherapy
This trial will try stronger targeted drug combinations for people with HER2-positive early breast cancer who don't respond well to initial dual HER2-targeted therapy plus chemotherapy.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.