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RecruitingNCT06787339CaloriteUpdated Sep 28, 2026

Capecitabine in Low Risk Triple Negative Breast Cancer

A Phase 2 interventional study of Capecitabine in Breast Cancer, sponsored by Fudan University. Recruiting at 1 site in China. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-09-28.

Sponsored by Fudan University · Phase 2, Interventional, and Treatment

Phase
Phase 2
Study type
Interventional
Enrollment
198
Allocation
Not applicable
Ages
18 Years and older
Sex
All
01

Study summary

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.

Read the detailed description

This study aims to evaluate the efficacy and safety of capecitabine as the only adjuvant chemotherapy drug in patients with low-risk T1N0M0 early triple-negative breast cancer who have received adequate local treatment. Patients meeting the inclusion criteria will receive capecitabine metronomic therapy for one year. The low-risk population defined in this study includes the IM subtype with abundant stromal tumor-infiltrating lymphocytes, or the LAR subtype with low ki-67 proliferation, or elderly patients.

02

Conditions studied

  • Breast Cancer

Keywords

  • adjuvant chemotherapy de-escalation
  • triple negative breast cancer
03

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

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

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
04

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrollment
198 participants (estimated)

Study arms

  • Experimental
    Capecitabine

    capecitabine metronomic therapy for one year

    Drug: Capecitabine

Interventions

  • DrugCapecitabine

    Capecitabine 650mg/m2, bid, p.o for 1 year

05

What researchers measure

Primary outcomes

  1. RFS

    recurrence free survival

    Time frame: 3 years

Secondary outcomes

  1. iDFS

    invasive disease-free survival

    Time frame: 3 years

  2. DRFS

    distant relapse-free survival

    Time frame: 3 years

  3. DFS

    disease-free survival

    Time frame: 3 years

  4. OS

    overall survival

    Time frame: 3 years

  5. adverse events

    adverse events according to CTCAE 5.0

    Time frame: 3 years

  6. PRO

    patient reported outcome

    Time frame: 3 years

06

Study locations

1 of 1 sites recruiting
  • breast cancer institute of Fudan University Shanghai Cancer Center
    Shanghai, Shanghai Municipality, China
    • Zhimin Shao, MD · Contact · zhimingshao@yahoo.com · 86-021-641755901105
    • Yin Liu, MD · Contact · liuyinfudan@163.com · 02164175590
    • Zhi-Ming Shao, MD · Principal investigator
    • Yin Liu · Sub investigator
    Recruiting
07

Registry details

Key details

Study ID
NCT06787339
Lead sponsor
Fudan University
Responsible party
Zhimin Shao (Professor, Fudan University) — Principal investigator
First posted
Jan 22, 2025
Start date
Jan 20, 2025
Primary completion
Dec 31, 2028 (estimated)
Completion
Jan 31, 2030 (estimated)
Last update
Sep 28, 2026

Study contacts

Zhimin C Shao
Contact
zhimingshao@yahoo.com
02164175590
Yin Liu
Contact
liuyinfudan@163.com
02164175590

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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