Neoadjuvant Effect of Albumin Binding Paclitaxel Compared With Common Paclitaxel in Breast Cancer：an Observational Single Center Study of Clinical Efficacy in Adjuvant Chemotherapy

Summary

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.

Conditions

• Breast Cancer

Interventions

DRUG

Taxol

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.

Sponsors & Collaborators

• Mei Zhang

  lead OTHER

Principal Investigators

• Guoming Liu, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

• Yonghao Li, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

• Xinlei Zhang, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

• Ximei Sun, master · The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Eligibility

Min Age

20 Years

Max Age

70 Years

Sex

FEMALE

Healthy Volunteers

No

Timeline & Regulatory

Start

2022-11-04

Primary Completion

2025-02-01

Completion

2025-06-16

FDA Drug

Yes

Countries

• China

Study Locations