To hear about similar clinical trials, please enter your email below
Trial Title:
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
Condition:
Breast Cancer
Conditions: Official terms:
Breast Neoplasms
Conditions: Keywords:
Paclitaxel，Neoadjuvant chemotherapy
Study type:
Observational
Overall status:
Recruiting
Study design:
Time perspective:
Other
Intervention:
Intervention type:
Drug
Intervention name:
Taxol
Description:
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.
Arm group label:
Group B
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.
Criteria for eligibility:
Study pop:
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.
Sampling method:
Non-Probability Sample
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.
Gender:
Female
Minimum age:
20 Years
Maximum age:
70 Years
Healthy volunteers:
No
Locations:
Facility:
Name:
The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
Address:
City:
Jinan
Country:
China
Status:
Recruiting
Contact:
Last name:
Mei Zhang, doctor
Phone:
13589102156
Email:
zhangmei@sdhospital.com.cn
Investigator:
Last name:
Guoming Liu, master
Email:
Principal Investigator
Investigator:
Last name:
Yonghao Li, master
Email:
Principal Investigator
Investigator:
Last name:
Xinlei Zhang, master
Email:
Principal Investigator
Investigator:
Last name:
Ximei Sun, master
Email:
Principal Investigator
Start date:
November 4, 2022
Completion date:
June 16, 2025
Lead sponsor:
Agency:
Mei Zhang
Agency class:
Other
Source:
Qianfoshan Hospital
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT05636644
