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NCT06787339From ClinicalTrials.govRecruiting

Capecitabine in Low Risk Triple Negative Breast Cancer

A Prospective, Single-arm,Clinical Trial Exploring the Efficacy and Safety of Chemotherapy De-escalation Using Capecitabine in Low-risk Early Triple-negative Breast Cancer

  • Breast Cancer

At a glance

Phase
Phase 2
Study type
Interventional
Sponsor
Fudan University
Enrolment target
198
Started
20 January 2025
Main results due
31 December 2028
Study sites
1
Registry updated
28 September 2026

Can you take part?

  • Aged 18 years and over.
  • Open to any sex.
  • You need the condition being studied — healthy volunteers are not accepted.

These are the headline rules only. Every study has a longer list, and whether you are eligible is decided by the research team at the site — never by this page.

Read the full eligibility criteria
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

What this study is about

In the sponsor’s own words, from the registry.

This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year.

Study sites(1)

  • breast cancer institute of Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, China

    Recruiting

Showing 1 of 1 sites. 1 of the 1 site on this study is recruiting right now — a site can stop enrolling while the study as a whole is still open.

Source: ClinicalTrials.gov record NCT06787339. Trialion does not run this study, is not paid to refer anyone to it, and cannot enrol you. Eligibility is always decided by the research team at the site.

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Capecitabine in Low Risk Triple Negative Breast Cancer | Trialion