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In recent years, the incidence rate of breast cancer has remained high. In China, breast cancer is the malignant tumor with the highest incidence rate among women. Although the research and development of various targeted drugs and the improvement of clinical treatment system have effectively improved the 5-year survival rate of breast cancer patients in China, the clinical treatment effect of breast cancer is still unsatisfactory. It is speculated that the main reasons for the poor clinical efficacy of breast cancer are drug tolerance, recurrence, distant metastasis, etc., which further leads to some limitations in the exploration of clinical drug development and regulatory mechanism. Paclitaxels are common chemotherapeutic drugs, which have been widely used in the treatment of breast cancer, ovarian cancer and some lung cancer. In2005, albumin binding paclitaxel was approved by FDA for the treatment of breast cancer patients. It is highly hydrophobic and requires a mixture of polyethylene castor oil and ethanol. These solvents will increase the toxic reactions of patients treated with paclitaxel, including severe allergic and anaphylactic reactions, and irreversible peripheral neuropathy, usually requiring the use of corticosteroids and antihistamines in advance.In order to further confirm the advantages of albumin binding paclitaxel and common paclitaxel chemotherapeutic drugs in neoadjuvant chemotherapy of breast cancer, this project intends to explore albumin binding based on different molecular types of breast cancer (luminal a, B, HER2 +, triple negative) An observational study on the efficacy of neoadjuvant chemotherapy with a-paclitaxel and common paclitaxel chemotherapeutic drugs. Randomized grouping confirmed the effectiveness of albumin binding paclitaxel replacing common paclitaxel in neoadjuvant chemotherapy of breast cancer with different molecular types, providing evidence-based medical evidence for the selection of paclitaxel chemotherapeutic drugs based on breast cancer molecular types. At the same time, the patients with poor efficacy among the patients who selected the neoadjuvant chemotherapy scheme for breast cancer according to the guidelines of NCCN and CSCO were screened for clinical transformation research (including basic experimental research, follow-up intensive treatment selection, and providing basis for entering other drug clinical trials). For the patients who achieved the clinical efficacy of PCR with neoadjuvant chemotherapy, we further analyzed the reasons to explore a better scheme of neoadjuvant chemotherapy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | anthracyclines+cyclophosphamide+other paclitaxel drugs | ||
| Group B | anthracyclines+cyclophosphamide+nab paclitaxel |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Taxol | Drug | All patients received TAC regimen: both groups received AC (epirubicin 75 mg/m ² and cyclophosphamide 500mg/m ²), Group A was treated with docetaxel for 6 cycles every 3 weeks (75 mg/m on the first day ²); Group B received six cycles of nab paclitaxel (125 mg/m ²), every 3 weeks is a course of treatment. |
| Measure | Description | Time Frame |
|---|---|---|
| Pathological complete remission (pCR) | Grade I: tumor focus basically unchanged; Grade II: ≤ 30% tumor cells disappear; Grade III: about 30-90% of tumor tissues disappear; Grade IV: ≥ 90% of tumor cells disappeared; Grade V: no residual invasive cancer tissue. Among them, if there is grade III or above, it indicates that the treatment is effective; if there is grade II or below, it indicates that the treatment is invalid; and grade V 5 indicates that the patient has reached pCR. | June 2025 |
| Measure | Description | Time Frame |
|---|---|---|
| Disease free survival (DFS) | June 2025 | |
| Complete remission (CR), partial remission (PR) and objective remission rate (ORR) of solid tumors | ①Complete remission (CR): all cancer foci disappeared, no new tumor foci appeared and maintained for at least 4 weeks; ② Partial remission (PR): the sum of the maximum diameters of tumor lesions decreased by ≥ 30% for at least 4 weeks; ③ Disease stability (SD): the sum of the largest diameters of tumor lesions decreased to PR, or increased to PD; ④ Disease progression (PD): The sum of the maximum diameters of tumor lesions increases by at least 20%, and its absolute value increases by at least 5 mm. The appearance of new lesions is also called PD. If the tumor has CR and PR, the original scheme is proved to be effective, and continue to treat according to the original scheme; In case of PD and SD, replace the scheme. |
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Inclusion Criteria:
Exclusion Criteria:
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Breast cancer patients with TNM stage T2-4N0-3M0 who were hospitalized in the breast surgery department of Shandong Qianfoshan Hospital from the time when the ethical approval document was obtained to December 2024.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mei Zhang, doctor | Contact | 13589102156 | zhangmei@sdhospital.com.cn |
| Name | Affiliation | Role |
|---|---|---|
| Guoming Liu, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| Yonghao Li, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Recruiting | Jinan | Shandong | China |
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|
| June 2025 |
| Xinlei Zhang, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| Ximei Sun, master | The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) | Principal Investigator |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D017239 | Paclitaxel |
| ID | Term |
|---|---|
| D043823 | Taxoids |
| D043822 | Cyclodecanes |
| D003516 | Cycloparaffins |
| D006840 | Hydrocarbons, Alicyclic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D004224 | Diterpenes |
| D013729 | Terpenes |
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