ctDNA in HER2+ EBC Neoadjuvant Treatment

Shanghai Jiao Tong University School of Medicine

Status and phase: Enrolling; Phase 2

Conditions: Breast Cancer

Treatments: Drug: docetaxel; Drug: trastuzumab; Drug: pertuzumab; Drug: pyrotinib

Study type: Interventional

Funder types: Other

Identifiers

NCT07335081

RJBC2401

Details and patient eligibility

About

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

Enrollment: 60 estimated patients

Sex: Female

Ages: 18 to 70 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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60 participants in 2 patient groups

Pyrotinib-initiated arm

Experimental group

Description:

two cycles of docetaxel + trastuzumab + pyrotinib followed by two cycles of docetaxel + trastuzumab + pertuzumab

Treatment:

Drug: pyrotinib

Drug: pertuzumab

Drug: trastuzumab

Drug: docetaxel

Pertuzumab-initiated arm

Active Comparator group

Description:

four cycles of docetaxel + trastuzumab + pertuzumab

Treatment:

Drug: pertuzumab

Drug: trastuzumab

Drug: docetaxel