Can one drug replace harsh chemo for some breast cancers?
NCT ID NCT06787339
First seen Sep 28, 2026 · Last updated Sep 29, 2026 · Updated 1 time
Summary
Researchers are testing whether a single oral chemotherapy drug, capecitabine, can safely replace standard multi-drug chemotherapy in people with low-risk early triple-negative breast cancer after surgery. The trial enrolls adults with small, lymph-node-negative tumors and gives them capecitabine for one year. The goal is to see if this gentler approach keeps cancer from returning while causing fewer side effects.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- capecitabine, an oral chemotherapy drug
- What this could lead to
- If it works, this could offer a gentler treatment option for people with low-risk early triple-negative breast cancer, possibly with fewer side effects than standard chemotherapy.
- What could go wrong
- This is a small, single-arm Phase 2 trial, so it cannot prove the approach is as good as standard chemotherapy. The cancer could return in some participants, and capecitabine has its own side effects.
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Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 198 people
The number the study aims to enrol. It can still change while the study runs.
- Started
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Jan 2025
- Expected to finish
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Jan 2030
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 years and older
- Sex
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Anyone
- 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. Male and female patients aged ≥18 years; 2. Pathological confirmed of stage I breast cancer: histologically confirmed that the longest diameter of invasive cancer is no more than 2cm and the lymph node is negative (N0); 3. Histologically documented TNBC after early breast cancer surgery (absence of HER2, ER, and PR expression) 4. Patients who have undergone standard and adequate surgical treatment; 5. Has adequate organ function meeting the following criteria: (1) adequate bone marrow function: hemoglobin ≥ 90 g/L (no blood transfusion within 14 days); absolute neutrophil count ≥ 1.5 x 109 /L; platelet count ≥ 100 \* 109 /L; (2)adequate liver and kidney function: Alanine Aminotransferase (ALT) ≤ 3×upper limit of normal (ULN), Aspartate Aminotransferase (AST) ≤ 3×ULN, Total Bilirubin (TBIL)≤ 1.5×ULN, serum creatinine ≤ 1×ULN#and with endogenous creatinine clearance rate of \>50 ml/min (Cockcroft-Gault formula); 6. No evidence of metastasis in clinical or imaging examinations before surgery, that is, M0; 7. ECOG score of 0 or 1; 8. Meeting one of the low-risk criteria defined in this study: a) IM subtype, that is, the proportion of stromal tumor-infiltrating lymphocytes is high or CD8 is high; b) LAR subtype and ki-67 less than 20%; c) Age ≥ 70 years. 8)The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up. Exclusion Criteria: 1. Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy; 2. Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ; 3. Has metastic (Stage 4) breast cancer; 4. Pregnant or breast feeding women, or people of childbearing age who cannot practice effective contraceptives; 5. Patients participating in other clinical trials at the same time; 6. Has severe organ dysfunction (cardiopulmonary liver and kidney) insufficiency, left ventricular ejection fraction (LVEF) \< 50% (cardiac ultrasound); severe cardio cerebral vascular disease within the 6 months previous of randomization (such as unstable angina, chronic heart failure, uncontrolled hypertension with blood pressure\>150/90mmHg, myocardial infarction, or cerebral blood vessel); diabetic patients with poor blood glucose control; patients with severe hypertension; Has severe or uncontrolled infection; 7) Has a history of psychotropic substance abuse and were unable to abandon drug habits, or those with history of mental disorders; 8)The researchers considered patients to be unsuitable for the study. 9)Has bilateral breast cancer
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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.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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breast cancer institute of Fudan University Shanghai Cancer Center
RECRUITINGShanghai, Shanghai Municipality, China
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