New study tests which chemo combo works best for common breast cancers
NCT ID NCT04193059
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This phase 3 trial compares two chemotherapy regimens for women with non-triple negative breast cancer after surgery. One group gets epirubicin plus cyclophosphamide followed by docetaxel (EC-T), the other gets paclitaxel plus carboplatin (PCb). The study includes 1560 participants and tracks how long they stay cancer-free. It also looks at side effects and overall survival.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- chemotherapy drugs (epirubicin, cyclophosphamide, docetaxel, paclitaxel, carboplatin, and trastuzumab)
- What this could lead to
- If successful, this could show that a carboplatin-based regimen works as well as or better than standard anthracycline-based chemo for certain breast cancer types, potentially reducing side effects.
- What could go wrong
- This is a single-center trial, so results may not apply broadly. Chemotherapy has well-known side effects like fatigue, nausea, and increased infection risk. The study is not testing a new drug, just comparing existing options.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 3
Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.
- Participants
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About 1,560 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Dec 2019
- Expected to finish
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Jul 2027
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Female patients aged 18-70 years old; 2. Histologically confirmed unilateral invasive breast cancer (regardless of pathological type) 3. Operable breast cancer at first diagnosis, without any absolute surgical contraindication. 4. No gross nor microscopic residual tumor after surgery. 5. HER2-positive with ≥ 1 positive axillary lymph node; or estrogen receptor (ER) and/or progesterone receptor (PR)-positive and HER2-negative with ≥ 4 positive axillary lymph node. HER2-positive is defined as an immunohistochemistry (IHC) status of 3+, or a positive in situ hybridization (Fluorescence in situ hybridization (FISH), Chromogenic in situ hybridization (CISH)) test. ER-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were ER positive. PR-positive is defined as immunohistochemistry showing that ≥ 1% of tumor cells were PR positive. 6. Preoperative examination found no evidence of metastasis in clinical examination nor imaging examination. 7. No peripheral neuropathy. 8. Karnofsky score \> 70. 9. Good postoperative recovery, at least 1 week has passed since most recent surgery. 10. Has adequate bone marrow function: leukocyte count \> 4x10ˆ9 / L, absolute neutrophil count \> 2x10ˆ9 /L; platelet count \> 100x10ˆ9 /L, hemoglobin \> 9g/dL. 11. Has adequate liver function: alanine aminotransferase (ALT) \< 1.5×upper limit of normal (ULN), aspartate aminotransferase (AST) \< 1.5×ULN, alkaline phosphatase (AKP) \< 2.5×ULN, total bilirubin (TBIL) \< 1.5×ULN. 12. Has adequate kidney function: serum creatinine \< 1.5×ULN. 13. Contraception during treatment for women of childbearing age. 14. Has adequate cardiac function: echocardiography showed left ventricular ejection fraction (LVEF) \> 50%. 15. Participants voluntarily joined the study, has signed informed consent before any trial related activities are conducted, has good compliance and has agreed to follow-up. Exclusion Criteria: 1. Has received previous chemotherapy for late stage disease. 2. Has bilateral breast cancer or bilateral carcinoma in situ. 3. Has metastatic (Stage 4) breast cancer. 4. Has clinical T4 lesion (UICC1987) (with skin involvement, mass adhesion and fixation, and inflammatory breast cancer). 5. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy). 6. Has previous history of additional malignancy(with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ), including contralateral breast cancer. 7. Is already participating in another clinical trial. 8. Has severe systemic disease and/or uncontrolled infection. 9. Has insufficient cardiac function: echocardiography showed LVEF\< 50%. 10. Has suffered from severe cardiovascular and cerebrovascular diseases disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90 mmHg, myocardial infarction, or cerebrovascular accident. 11. Has known allergy to chemotherapy drugs used in this study. 12. Is pregnant, is breast feeding, or is a woman of childbearing age who cannot practice effective contraceptives during treatment and until 8 weeks after the end of treatment. 13. Has entered the study, but pre-treatment examination showed a positive pregnancy test. 14. Has a history of mental disorders, cognitive impairment, inability to understand the study protocol and side effects, inability to complete the study protocol and follow-up workers (systematic evaluation is required before the patient is enrolled into the study), or is without independent civil capacity. 15. The researchers judged patients to be unsuitable for the study.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
Contacts and locations
Locations
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Cancer Hospital Affiliated to Fudan University
Shanghai, Shanghai Municipality, 200032, China
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