Using albumin-bound paclitaxel to treat triple-negative breast cancer before surgery

Treatment of Triple-negative Breast Cancer With Albumin-bound Paclitaxel as Neoadjuvant Therapy: a Prospective Randomized Controlled Clinical Trial

This study is testing if a new type of chemotherapy using albumin-bound paclitaxel can help women with triple-negative breast cancer before surgery, compared to the standard treatment.

Quick facts

• Phase: Phase 3
• Study type: Interventional
• Enrollment: 1498 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shengjing Hospital (Academic / other)
• Locations: 1 site (Shenyang, Liaoning)
• Trial ID: NCT04137653 on ClinicalTrials.gov

What this trial studies

This clinical trial investigates the effectiveness of albumin-bound paclitaxel (nab-P) as a neoadjuvant therapy for patients with triple-negative breast cancer (TNBC). The study compares nab-P combined with carboplatin to traditional solvent-based paclitaxel with carboplatin. It aims to evaluate the therapeutic benefits of nab-P, which utilizes albumin nanoparticles to enhance drug delivery to tumors, potentially improving patient outcomes. The trial includes women aged 18-70 with confirmed TNBC and positive axillary lymph node metastasis.

Who should consider this trial

Good fit: Ideal candidates are women aged 18-70 with confirmed triple-negative breast cancer and positive axillary lymph node metastasis.

Not a fit: Patients with distant metastasis, other cancers, or severe allergies to paclitaxel may not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could lead to improved outcomes and reduced recurrence rates for patients with triple-negative breast cancer.

How similar studies have performed: Previous studies have shown that albumin-bound paclitaxel is superior to solvent-based paclitaxel in treating breast cancer, indicating a promising approach.

Eligibility criteria

Inclusion Criteria:

* breast cancer is confirmed by the mammography, and the immunohistochemical results of cancer tissues are negative for estrogen receptor, progesterone receptor and anti-human epidermal growth factor receptor 2;
* positive for axillary lymph node metastasis;
* 18-70 years of age, female;
* patients have good compliance with the planned treatment, who are volunteer to participate in the study, are willing to be treated with solvent-based paclitaxel or nab-P at random, and provide written informed consent with the premise of fully understanding the study protocol.

Exclusion Criteria:

* pregnant and lactating women;
* distant metastasis;
* patients with a history of other cancers or who have received radiotherapy on the chest;
* abnormalities in blood tests or presence of other symptoms of infection;
* allergy to paclitaxel;
* patients who have psychotropic drug abuse until now or those with a history of mental disorders;
* abnormalities in important organs such as the heart, lung, liver and kidney;
* patients who have participated in other clinical trials.

Where this trial is running

Shenyang, Liaoning

• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)

Study contacts

• Principal investigator: Caigang Liu, M.D., Ph.D. — Shengjing Hospital
• Study coordinator: Xi Gu, M.D.

Conditions Breast Cancer; paclitaxel; albumin-bound paclitaxel; neoadjuvant therapy