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ctDNA in HER2+ EBC Neoadjuvant Treatment

RECRUITINGPhase 2Sponsored by Shanghai Jiao Tong University School of Medicine
Actively Recruiting
PhasePhase 2
SponsorShanghai Jiao Tong University School of Medicine
Started2024-02-01
Est. completion2025-12-31
Eligibility
Age18 Years – 70 Years
SexFEMALE
Healthy vol.Accepted
View on ClinicalTrials.gov →

NCT07335081

Summary

This study is a randomized, open-label, multicenter clinical study for patients with early or locally advanced (T≥2cm, N0-3, M0) HER2-positive breast cancer, aiming to compare the peripheral blood ctDNA clearance of neoadjuvant pyrotinib + trastuzumab + docetaxel and pertuzumab + trastuzumab + docetaxel for one course and to evaluate the therapeutic effectiveness of four courses of neoadjuvant therapy

Eligibility

Age: 18 Years – 70 YearsSex: FEMALEHealthy volunteers accepted
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

Conditions2

Breast CancerCancer

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