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

NCT ID: NCT05636644

Last Updated: 2022-12-05

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 112 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2022-11-04
• Study Completion Date: 2025-06-16

Brief 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

Study Design

• Observational Model Type: CASE_CONTROL
• Study Time Perspective: OTHER

Study Groups

Group A

anthracyclines+cyclophosphamide+other paclitaxel drugs

No interventions assigned to this group

Group B

anthracyclines+cyclophosphamide+nab paclitaxel

Taxol

Intervention Type: 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.

Interventions

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.

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 1. Female breast cancer patients aged ≥ 20 years and ≤ 70 years, with informed consent and meeting the treatment standard of neoadjuvant chemotherapy scheme; 2. Invasive breast cancer with TNM stageT2-4N0-3M0; 3.No treatment for breast cancer before enrollment, such as chemotherapy, targeted therapy and endocrine therapy; 4.All patients underwent thick needle biopsy of breast tumors (patients suspected of axillary lymph node metastasis should undergo lymph node biopsy) to determine the status of ER, PR, HER-2 and Ki-67; 5. All patients had normal cardiopulmonary function, liver and kidney function.

Exclusion Criteria

• 1. The patient does not cooperate and is unwilling to sign the informed consent form; 2. The tumor has been confirmed to have distant metastasis; 3. Antitumor therapy, hormone replacement therapy and other breast cancer related treatments were performed before enrollment; 4. Any other malignant tumor is combined; 5. Patients with active infection, HIV history or chronic hepatitis B or C; 6. Persons with abnormal heart and lung functions or liver and kidney functions; 7.Other clinical researchers in recent 3 months.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Mei Zhang

OTHER

Sponsor Role: lead

Responsible Party

Mei Zhang

Deputy chief physician

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guoming Liu, master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Yonghao Li, master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Xinlei Zhang, master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Ximei Sun, master

Role: PRINCIPAL_INVESTIGATOR

The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Locations

The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)

Jinan, Shandong, China

Site Status: RECRUITING

Countries

China

Central Contacts

Mei Zhang, doctor

Role: CONTACT

zhangmei@sdhospital.com.cn

13589102156

Facility Contacts

Mei Zhang, doctor

Role: primary

zhangmei@sdhospital.com.cn

13589102156

Other Identifiers

YXH2022ZX02167

Identifier Type: -

Identifier Source: org_study_id