A Phase 2 interventional study of HER2 target therapy in Breast Cancer (Early Breast Cancer), sponsored by Peking University People's Hospital. Not yet recruiting at 1 site in China. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.
Sponsored by Peking University People's Hospital · Phase 2, Interventional, and Treatment
This study adopts a single-center, open-label, single-arm interventional design. It will enroll 88 patients with histologically confirmed HER2-positive early breast cancer who are suitable for surgery and neoadjuvant therapy, and stratify them by HER2 homogeneity/heterogeneity based on histological analysis. Subjects are not randomized and all will enter the intervention arm; patients with different HER2 homogeneity/heterogeneity will receive regimens based on anti-HER2 antibody-drug conjugates (ADCs). Recruitment is planned to commence in January 2027 and complete enrollment by December 2028. After obtaining fully informed consent and meeting eligibility criteria, eligible subjects will enter the trial phase and receive a regimen based on anti-HER2 ADCs. Once enrolled, subjects must receive the investigational drug within 72 hours. Each treatment cycle lasts 3 weeks, for a total of 8 cycles, and treatment will continue until the end of the course or until disease progression, unacceptable toxicity, death, withdrawal of informed consent, loss to follow-up, study completion, or study termination.
Exclusion Criteria:
Based on HER2 immunohistochemistry (IHC) results, HER2 homogeneity/heterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy.
Drug: HER2 target therapy
Based on HER2 immunohistochemistry (IHC) results, HER2 homogeneity/heterogeneity will be defined. Patients with homogeneous HER2 expression will receive 8 cycles of T-DXd therapy, while patients with heterogeneous HER2 expression will receive sequential T-DXd followed by THP therapy.
pathology complete response rate
After completing neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\&E)-stained samples from the resected breast cancer tissue and all ipsilateral lymph node specimens shows no residual invasive carcinoma.
Time frame: From enrollment to the end of treatment at 6 months
bpCR
After completion of neoadjuvant therapy, histopathological evaluation of hematoxylin and eosin (H\&E)-stained resected breast cancer tissue shows no residual invasive carcinoma.
Time frame: From enrollment to the end of treatment at 6 months
ORR
The proportion of subjects achieving complete response (CR) or partial response (PR) during neoadjuvant therapy as the best overall tumor response. Investigators will assess objective response rate (ORR) according to RECIST v1.1.
Time frame: From enrollment to the end of treatment at 6 months
RCB
The Residual Cancer Burden (RCB) index and its corresponding RCB class (RCB 0-III) can be calculated from the primary tumor residual size (mm×mm), tumor cellularity (percentage), proportion of in situ carcinoma (percentage), the number of positive lymph nodes, and the greatest dimension of nodal metastasis (mm).
Time frame: From enrollment to the end of treatment at 6 months
Plan to share: No
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This study is not yet recruiting, as verified in Sep 2026. You cannot join it, but the record below documents what was studied.
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Peking University People's Hospital