De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients
NacHER2
NacHER2
Sponsor study identifier
observational
519
1 country
1
Study Start
January 1, 2015
Actual (reported)Primary Completion
December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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.
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 1, 2015
Actual (reported)November 20, 2024
Actual (reported)November 22, 2024
Actual (reported)December 31, 2028
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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)
6 months
Invasive disease free survival
5 years
Disease free survival
5 years
Breast cancer specific survival
5 years
Overall survival
5 years
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
HER2 positive breast cancer patients who received neoadjuvant chemotherapy based on taxanes with trastuzumab, pertuzumab target therapy
Peking University People's Hospital
Beijing, Beijing Municipality, 100044, China
shu wang
Peking University People's Hospital
First Submitted
November 20, 2024
First Posted
November 22, 2024
Study Start
January 1, 2015
Actual (reported)Primary Completion
December 31, 2028
EstimatedAdjuvant Therapy Choice for Non-pCR HER2 Positive Early Breast Cancer After Neoadjuvant Therapy
TCH Versus EC-TH as Neoadjuvant Treatment for HER2-Positive Breast Cancer
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Planned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
December 31, 2031
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
November 25, 2024
Record last verified: 2024-11
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