Comparing two chemotherapy regimens for triple-negative breast cancer

Albumin-bound Paclitaxel Combined With Carboplatin Versus Epirubicin Combined With Docetaxel as Neoadjuvant Therapy for Triple-negative Breast Cancer: a Multicenter Randomized Controlled Phase IV Clinical Trial

This study is testing which chemotherapy combination works better for people with stage II-III triple-negative breast cancer to help shrink tumors and improve survival.

Quick facts

• Phase: Phase 4
• Study type: Interventional
• Enrollment: 110 (estimated)
• Ages: 18 Years to 70 Years
• Sex: Female
• Sponsor: Shengjing Hospital (Academic / other)
• Drugs / interventions: chemotherapy
• Locations: 7 sites (Harbin, Heilongjiang and 6 other locations)
• Trial ID: NCT04136782 on ClinicalTrials.gov

What this trial studies

This study investigates the effectiveness of albumin-bound paclitaxel combined with carboplatin compared to epirubicin combined with docetaxel as neoadjuvant therapy for patients with triple-negative breast cancer. Triple-negative breast cancer is a challenging subtype due to its aggressive nature and limited treatment options. The trial aims to determine which chemotherapy regimen provides better outcomes in terms of tumor response and overall survival. Eligible participants will be those with stage II-III triple-negative breast cancer who meet specific health criteria.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18-70 with stage II-III triple-negative breast cancer and a Karnofsky functional status score of 70 or higher.

Not a fit: Patients with stage IV breast cancer or those who have previously received antineoplastic therapy may not benefit from this study.

Why it matters

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

How similar studies have performed: Other studies have explored chemotherapy regimens for triple-negative breast cancer, but this specific comparison is novel.

Eligibility criteria

Inclusion Criteria:

* patients developing breast cancer as confirmed by X-ray examination, cancer tissue negative for estrogen receptor, progesterone receptor and HER2, and tumor stage II-III;
* estimated survival \> 3 months;
* presence of clinically measurable lesions;
* Karnofsky functional status score ≥ 70;
* normal routine blood test results, normal liver and kidney function, and near normal electrocardiographic manifestations;
* age at 18-70 years.

Exclusion Criteria:

* stage IV breast cancer patients with bone metastasis or other distant metastasis;
* severe renal insufficiency;
* older adult patients with severe organic diseases such as heart and lung diseases, who are not estimated to be able to tolerate chemotherapy;
* those who have received antineoplastic therapy;
* those who have received neoadjuvant chemotherapy but fail in 2 cycles of neoadjuvant chemotherapy and switch to other regimens or terminate chemotherapy;
* those with history of other malignant tumors;
* those with severe heart, liver, and kidney organ dysfunction or poor health who cannot tolerate chemotherapy, or those who cannot tolerate chemotherapy and switch to other therapeutic regimens;
* those with mental and nervous system diseases who cannot comply with treatment;
* those with dexamethasone intolerance or those who are highly allergic to any drug in neoadjuvant chemotherapy;
* pregnant or lactating women;
* those who are participating in other trials.

Where this trial is running

Harbin, Heilongjiang and 6 other locations

• Cancer Hospital Affiliated to Harbin Medical University — Harbin, Heilongjiang, China (Recruiting)
• The Second Hospital of Jilin University — Changchun, Jilin, China (Recruiting)
• Dalian Municipal Central Hospital — Dalian, Liaoning, China (Recruiting)
• Panjin Liaohe Oilfield Gem Flower Hospital — Panjin, Liaoning, China (Recruiting)
• Shengjing Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• The Fourth Affiliated Hospital of China Medical University — Shenyang, Liaoning, China (Recruiting)
• Liaoning Cancer Hospital & Institute — 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; adjuvant chemotherapy; paclitaxel; albumin-bound paclitaxel; carboplatin; docetaxel; epirubicin