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The traditional neoadjuvant therapy for triple negative breast cancer is based on anthracycline, paclitaxel and carboplatin. Nowadays, immunotherapy combined with chemotherapy has become a new standard treatment, which not only benefits from pathological complete response (pCR), but also benefits from long-term survival. The standard chemotherapy combined with immunotherapy scheme recommended by the guidelines is TCb-AC combined with pabolizumab, but the complex chemotherapy scheme has the defects of long cycle and large adverse reactions, and the scheme of chemotherapy reduction has been explored.
This project plans to adopt an ambispective 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 triple negative breast cancer patients with clinical stage T2 and above and/or lymph node positive who received neoadjuvant therapy (TCb-AC combined with immunotherapy, or TCb combined with immunotherapy) admitted to the center from January 1, 2019 to November 31, 2024. Patients of the same type from December 1, 2024 to December 31, 2028 were prospectively included. The efficacy and safety of different treatment regimens were compared.
Investigators retrospectively recruited the triple negative breast cancer patients with clinical stage T2 and above and/or lymph node positive who received neoadjuvant therapy (TCb-AC combined with immunotherapy, TCb combined with immunotherapy, or TCb chemotherapy only) admitted to the center from January 1, 2019 to November 31, 2024. Patients of the same type from December 1, 2024 to December 31, 2028 were prospectively included. The efficacy and safety of different treatment regimens were compared.
Inclusion Criteria:
Exclusion Criteria:
Primary end point: pathology complete response
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Taxanes combined with carboplatin sequential anthracycline | Paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 4 cycles, followed by anthracycline combined with cyclophosphamide for 4 cycles, and PD-1 inhibitor was used at the same time | ||
| Taxanes combined with carboplatin | paclitaxel, liposome paclitaxel, docetaxel, or albumin paclitaxel combined with carboplatin for 6 cycles, and PD-1 inhibitor was used at the same time |
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| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | 5 years |
| Disease free survival |
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Inclusion Criteria:
Exclusion Criteria:
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triple negative breast cancer patients who received neoadjuvant chemotherapy based on taxanes combined with carboplatin
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| yuan peng, doctor | Contact | 86+13671287670 | 13671287670@163.com |
| Name | Affiliation | Role |
|---|---|---|
| shu wang | Peking University People's Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Peking University People's Hospital | Recruiting | Beijing | Beijing Municipality | 100044 | China |
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| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
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Tumor paraffin sample for each patient
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. |
| 5 years |
| Breast cancer specific survival | time from study enrollment to death due to breast cancer. | 5 years |
| Overall survival | the time from study enrollment to death from any cause | 5 years |
| D012871 |
| Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |