Capecitabine in Low Risk Triple Negative Breast Cancer

NCT06787339 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SCHBCC-N065
• Study Type: interventional
• Target: 198
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Breast Cancer

Keywords

adjuvant chemotherapy de-escalation; triple negative breast cancer

Outcome Measures

Primary Outcomes (1)

• RFS

  recurrence free survival

  3 years

Secondary Outcomes (6)

• iDFS

  3 years

• DRFS

  3 years

• DFS

  3 years

• OS

  3 years

• adverse events

  3 years

Study Arms (1)

Capecitabine

EXPERIMENTAL

capecitabine metronomic therapy for one year

Drug: Capecitabine

Interventions

Capecitabine DRUG

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

Capecitabine

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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;
• 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);
• No evidence of metastasis in clinical or imaging examinations before surgery, that is, M0;
• ECOG score of 0 or 1;
• 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.
• )The patient voluntarily joined the study, signed the informed consent form, had good compliance, and cooperated with the follow-up.

You may not qualify if:

• 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;
• Patients participating in other clinical trials at the same time;
• 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

Sponsors & Collaborators

• Fudan University: lead

Study Sites (1)

breast cancer institute of Fudan University Cancer Hospital

Shanghai, Shanghai Municipality, China

Location

MeSH Terms

Conditions

Breast Neoplasms; Triple Negative Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Deoxycytidine; Cytidine; Pyrimidine Nucleosides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Fluorouracil; Uracil; Pyrimidinones; Deoxyribonucleosides; Nucleosides; Nucleic Acids, Nucleotides, and Nucleosides

Central Study Contacts

Zhimin C Shao

CONTACT

02164175590; zhimingshao@yahoo.com

Yin Liu

CONTACT

02164175590; liuyinfudan@163.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: January 13, 2025
• First Posted: January 22, 2025
• Study Start: January 15, 2025
• Primary Completion (Estimated): December 31, 2028
• Study Completion (Estimated): January 31, 2030
• Last Updated: January 22, 2025

Record last verified: 2025-01

Locations

CN (1)