Clinical trial Recruiting at 7 sites Phase 4 Interventional Ages 18 to 70 Women only

Comparing two chemotherapy regimens for triple-negative breast cancer

Official title: 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

Run by Shengjing Hospital · NCT04136782 · Data updated 2026-11-12

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

PhasePhase 4
Study typeInterventional
Ages18 Years to 70 Years
SexWomen only
Enrollment110 (estimated)
SponsorShengjing Hospital
Academic / other
Drugs / interventionschemotherapy
Locations7 sites (Harbin, Heilongjiang and 6 other locations)
StatusRecruiting
StartedJuly 19, 2021
Main results expectedNovember 30, 2025
Study endsNovember 30, 2026
Registry record updatedJuly 20, 2021
Trial IDNCT04136782 on ClinicalTrials.gov

Is this trial a fit for you?

Likely a 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.

Probably not a fit

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

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

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.

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

Who can join: the full rules

Show full inclusion / exclusion 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 it's running

  • 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
Show 1 more location
  • 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.
  • Email: jadegx@163.com
  • Phone: +86 18940255116

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

How to take part

  1. Review the eligibility criteria above with your treating physician.
  2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
  3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.
Last reviewed 2026-11-14 by the Find a Trial editorial team. Information on this page is for educational purposes and is not medical advice. Always consult qualified healthcare professionals about clinical trial participation.