Comparing albumin binding paclitaxel and common paclitaxel for breast cancer treatment

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

This study is testing whether a new type of paclitaxel that binds to albumin works better than the regular paclitaxel for women with invasive breast cancer who are starting chemotherapy.

Quick facts

• Study type: Observational
• Enrollment: 112 (estimated)
• Ages: 20 Years to 70 Years
• Sex: Female
• Sponsor: Qianfoshan Hospital (other)
• Drugs / interventions: chemotherapy
• Locations: 1 site (Jinan, Shandong)
• Trial ID: NCT05636644 on ClinicalTrials.gov

What this trial studies

This observational study aims to evaluate the clinical efficacy of albumin binding paclitaxel compared to standard paclitaxel in women undergoing neoadjuvant chemotherapy for breast cancer. The study will include female patients aged 20 to 70 years with invasive breast cancer at specific TNM stages who have not received prior treatment. Participants will undergo a thorough assessment, including biopsies to determine tumor characteristics, and will be monitored for treatment outcomes. The goal is to better understand the effectiveness of these two chemotherapy agents in improving patient outcomes.

Who should consider this trial

Good fit: Ideal candidates are female breast cancer patients aged 20 to 70 years with invasive breast cancer at TNM stages T2-4N0-3M0 who have not received prior treatment.

Not a fit: Patients with confirmed distant metastasis or those who have undergone prior antitumor therapies will not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to improved treatment options for breast cancer patients, potentially enhancing their response to chemotherapy.

How similar studies have performed: While there have been studies on paclitaxel, the specific comparison of albumin binding paclitaxel in this context is relatively novel and has not been extensively tested.

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.

Where this trial is running

Jinan, Shandong

• The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital) — Jinan, Shandong, China (RECRUITING)

Study contacts

• Principal investigator: Guoming Liu, master — The First Affiliated Hospital of Shandong First Medical University (Qianfo Mountain Hospital)
• Study coordinator: Mei Zhang, doctor

Conditions: Breast Cancer, Paclitaxel，Neoadjuvant chemotherapy