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
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 70 Years |
| Sex | Women only |
| Enrollment | 110 (estimated) |
| Sponsor | Shengjing Hospital Academic / other |
| Drugs / interventions | chemotherapy |
| Locations | 7 sites (Harbin, Heilongjiang and 6 other locations) |
| Status | Recruiting |
| Started | July 19, 2021 |
| Main results expected | November 30, 2025 |
| Study ends | November 30, 2026 |
| Registry record updated | July 20, 2021 |
| Trial ID | NCT04136782 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.
-
Gyrotonic exercise for elders with breast cancer and Behcet disease
We’re testing whether a gyrotonic exercise program helps older people who have both Behcet disease and breast cancer.
-
PECS II vs SPSIP nerve blocks for pain after mastectomy
This study tests whether two ultrasound-guided nerve blocks (PECS II and SPSIP) differ in how much opioid patients need after mastectomy.
-
CG-7321: a first-in-human test in advanced solid tumors
We’re testing CG-7321 alone and with fulvestrant to see if it’s safe and tolerable in adults with advanced solid tumors.
-
Compare a new endoscopy-assisted breast-conserving surgery with the usual approach
This study tests whether a new endoscopy-assisted breast-conserving technique can provide similar or better cosmetic outcomes and safety compared with conventional breast-conserving surgery in women with early breast cancer who want to preserve their breast.
-
Different skin care approaches to prevent skin reactions after mastectomy radiation
This study tests three standard skin care methods to see which best prevents radiation dermatitis in people who had a mastectomy and are receiving post-mastectomy radiation therapy.
-
3D Heart Strain to Detect Early Cardiotoxicity in Cancer Therapy
This study tests whether 3D echocardiography can detect early heart damage from cancer treatments like anthracyclines or HER2-targeted therapy better than standard 2D methods.
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.