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OncoMatch/Clinical Trials/NCT07335081

ctDNA in HER2+ EBC Neoadjuvant Treatment

Is NCT07335081 recruiting? Yes, currently enrolling (Jun 2026). This Phase 2 trial studies multiple treatments including pyrotinib and pertuzumab for breast cancer.

Phase 2RecruitingShanghai Jiao Tong University School of MedicineNCT07335081Data as of Jun 2026Location: China

Treatment: pyrotinib · pertuzumab · trastuzumab · docetaxelThis 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

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Extracted eligibility criteria

Treatments studied

Targeted therapy

pyrotinibpertuzumabtrastuzumab

Chemotherapy

docetaxel

Cancer type

Breast Carcinoma

Biomarker criteria

Required: HER2 (ERBB2) overexpression

Disease stage

Required: Stage II, III

Stage II-III HER2+ breast cancer (primary diameter >2cm)

Performance status

ECOG 0–1(Restricted strenuous activity)

Demographics

Ages ≤ 70
Female only

Prior therapy

No prior treatment (treatment-naive required)
Max 0 prior lines

Lab requirements

Blood counts

intact bone marrow function

Kidney function

intact renal function

Liver function

intact hepatic function

Cardiac function

baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography

Intact renal, hepatic, bone marrow and cardiac functions including baseline left ventricular ejection fraction (LVEF) ≥ 55% measured by echocardiography

Structured fields extracted by AI. May contain errors — verify against the official protocol.

Frequently asked questions

Is NCT07335081 currently recruiting?

Yes, this trial is currently recruiting patients.

Can patients have received prior systemic therapy?

No. This trial requires treatment-naive patients — prior systemic therapy is an exclusion criterion.

Does this trial require ERBB2?

Yes, ERBB2 overexpression is a required biomarker for enrollment.

What disease stage is eligible?

Stage II or III is required.

Is there an age limit?

Yes. Patients must be 70 years or younger.

Is this trial open to male patients?

No. This trial enrolls female patients only.

Could you qualify for this trial?

Enter your biomarker results to see how this trial's eligibility criteria match your specific cancer profile.

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