Using blood ctDNA to compare two pre-surgery HER2-positive breast cancer regimens
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
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 |
| Enrollment | 60 (estimated) |
| Ages | 18 Years to 70 Years |
| Sex | Female |
| Sponsor | Shanghai Jiao Tong University School of Medicine Academic / other |
| Drugs / interventions | trastuzumab, pertuzumab, pyrotinib |
| Locations | 1 site (Shanghai) |
| Trial ID | NCT07335081 on ClinicalTrials.gov |
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.
Who should consider this trial
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.
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.
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 performed: 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.
Eligibility criteria
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 this trial is running
Shanghai
- Ruijin Hospital — Shanghai, China (Recruiting)
Study contacts
- Study coordinator: Haoyu Wang
- Email: meredithwhy@163.com
- Phone: 86 18817865256
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.