An observational study in HER2-positive Breast Cancer, sponsored by Shu Wang. Recruiting at 1 site in China. Per ClinicalTrials.gov, last updated 2024-11-25.
Sponsored by Shu Wang · Observational
Neoadjuvant therapy is currently the standard treatment process for locally advanced breast cancer, especially for human epidermal growth factor receptor 2 (HER2) positive and triple negative breast cancer, which meets the requirements of tumor ≥ 2cm and/or lymph node positive, and the guidelines recommend neoadjuvant therapy as the first choice. Chemotherapy combined with trastuzumab and pertuzumab is the standard neoadjuvant therapy for HER2 positive breast cancer patients. Taxane plus carboplatin (TCb) is the first choice of chemotherapy recommended by major guidelines; As an alternative, single drug Taxane (T) is also listed as class I recommendation in the latest CSCO guidelines, but the level of evidence is slightly insufficient. Considering the defects such as large side effects of combined chemotherapy, whether single drug chemotherapy can be used as the first choice for some people under the support of targeted drugs remains to be studied.
This project plans to a cohort study, based on the large sample breast disease cohort database established by the breast center of Peking University People's Hospital, and retrospectively include the patients with clinical stage T2 and above and/or lymph node positive breast cancer who received neoadjuvant therapy (TCbHP or THP) from January 1, 2015 to December 31, 2024. Patients of the same type were prospectively included from January 1, 2025 to December 31, 2028. The effectiveness and safety of TCbHP and THP as a neoadjuvant therapy were compared.
Shu Wang is the lead sponsor of 8 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
HER2 positive breast cancer patients who received neoadjuvant chemotherapy based on taxanes with trastuzumab, pertuzumab target therapy
Exclusion Criteria:
Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel), carboplatin combined with trastuzumab and pertuzumab, 6 cycles in total
Taxane (paclitaxel, liposome paclitaxel, docetaxel, albumin paclitaxel) with trastuzumab and pertuzumab, 6 cycles in total
pathology complete response
Postoperative pathology confirmed that the primary breast lesions and axillary lymph nodes had no residual invasive tumor cells (ypT0/is and ypN0)
Time frame: 6 months
Invasive disease free survival
the time from study enrollment to the first occurrence of the following events defined as failure: local recurrence of ipsilateral invasive breast cancer, contralateral invasive breast cancer, distant recurrence or death from any cause.
Time frame: 5 years
Disease free survival
the time from study enrollment to the first occurrence of the following events defined as failure, including ipsilateral local recurrence, contralateral breast cancer, distant recurrence or death from any cause.
Time frame: 5 years
Breast cancer specific survival
time from study enrollment to death due to breast cancer.
Time frame: 5 years
Overall survival
the time from study enrollment to death from any cause
Time frame: 5 years
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Shu Wang