RecruitingNCT06700369

De-escalation of Neoadjuvant Chemotherapy Regimens With Targeted Therapy Among HER2 Positive Patients

De-escalation of Neoadjuvant Chemotherapy Regimens (Taxanes Plus Carboplatin Versus Taxanes Only) With Target Therapy Among HER2 Positive Patients


Sponsor

Shu Wang

Enrollment

519 participants

Start Date

Jan 1, 2015

Study Type

OBSERVATIONAL

Conditions

Summary

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.


Eligibility

Plain Language Summary

Simplified for easier understanding

This study is looking at whether reducing the number of chemotherapy drugs given before surgery (neoadjuvant chemotherapy) while keeping targeted therapies is safe and effective for people with HER2-positive breast cancer — a type of breast cancer driven by a specific protein. **You may be eligible if...** - You have HER2-positive breast cancer confirmed by biopsy - Your cancer is Stage II or III (meaning the tumor is large and/or has spread to nearby lymph nodes, but not to distant organs) - You were treated at Peking University People's Hospital and have hospitalization records - You have agreed to join the hospital's breast disease research cohort **You may NOT be eligible if...** - Your medical or pathological records are incomplete - You have breast cancer that has spread to distant parts of the body, or cancer in both breasts - You have been in another cancer clinical trial at the same time - You received a chemotherapy regimen other than the standard ones used in this study Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Locations(1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

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NCT06700369


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