Health TrialsbyHealthPanel

Capecitabine in Low Risk Triple Negative Breast Cancer

ConditionBreast Cancer
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18+
SponsorFudan University

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Male and female patients aged ≥18 years;

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);

Histologically documented TNBC after early breast cancer surgery (absence of HER2, ER, and PR expression)

Patients who have undergone standard and adequate surgical treatment;

Disqualifiers

Has received neoadjuvant therapy (include chemotherapy, targeted therapy, radiotherapy or endocrine therapy;

Has previous history of additional malignancy, with the exception of adequately treated basal cell carcinoma and cervical carcinoma in situ;

Has metastic (Stage 4) breast cancer;

Pregnant or breast feeding women, or people of childbearing age who cannot practice effective contraceptives;

Trial design

Design model

Single group

Treatments tested in this trial

  • Capecitabine

    Drug

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

Treatment groups

198 Participants
are divided into 1 treatment group
Group A: CapecitabineExperimental treatment 1 intervention

Trial outcomes

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

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Fudan University

Lead sponsor

Source ClinicalTrials.gov
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