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New study tests which chemo combo works best for common breast cancers

NCT ID NCT04193059

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing This study
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

Phase 3

Large-scale testing in a bigger group. Usually the last step before a treatment can be approved.

Participants

About 1,560 people

The number the study aims to enrol. It can still change while the study runs.

Started

Dec 2019

Expected to finish

Jul 2027

An estimate. End dates often move.

Lead sponsor

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

18 to 70 years

Sex

Female participants only

Healthy volunteers

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

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

  • Cancer Hospital Affiliated to Fudan University

    Shanghai, Shanghai Municipality, 200032, China

More trials for these conditions

Other studies related to the condition(s) this trial covers.