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

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.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Drug: Taxol

• Study Type: Observational
• Enrollment (Anticipated): 112

Contacts and Locations

• Study Contact: Name: Mei Zhang, doctor; Phone Number: 13589102156; Email: zhangmei@sdhospital.com.cn

Study Locations

• China
  • Shandong
    • Jinan, Shandong, China
      • Recruiting
      • The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
      • Contact: Mei Zhang, doctor; Phone Number: 13589102156; Email: zhangmei@sdhospital.com.cn
      • Principal Investigator: Guoming Liu, master
      • Principal Investigator: Yonghao Li, master
      • Principal Investigator: Xinlei Zhang, master
      • Principal Investigator: Ximei Sun, master

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 20 years to 70 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• Sampling Method: Non-Probability Sample

Study Population

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.

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Group A; anthracyclines+cyclophosphamide+other paclitaxel drugs
Group B; anthracyclines+cyclophosphamide+nab paclitaxel	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Disease free survival (DFS)		June 2025
Complete remission (CR), partial remission (PR) and objective remission rate (ORR) of solid tumors	① Complete 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.	June 2025

Collaborators and Investigators

• Sponsor: Mei Zhang
• Investigators: Principal Investigator: 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); Principal Investigator: 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)

Study record dates

Study Major Dates

• Study Start (Actual): November 4, 2022
• Primary Completion (Anticipated): February 1, 2025
• Study Completion (Anticipated): June 16, 2025

Study Registration Dates

• First Submitted: November 24, 2022
• First Submitted That Met QC Criteria: November 24, 2022
• First Posted (Actual): December 5, 2022

Study Record Updates

• Last Update Posted (Actual): December 5, 2022
• Last Update Submitted That Met QC Criteria: November 24, 2022
• Last Verified: November 1, 2022

More Information

Terms related to this study

• Keywords: Paclitaxel，Neoadjuvant chemotherapy
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: YXH2022ZX02167

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: Yes
• Studies a U.S. FDA-regulated device product: No