Capecitabine as Maintenance Therapy vs Observation in Early-stage Triple-negative Breast Cancer

NCT07143097 | Completed Phase 2 DMC FDA Drug

• 1 other identifier: FMBSUREC/10102021/Sayed
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief Summary

Eligible patients was assigned in a 1:1 ratio to receive either low-dose capecitabine maintenance (intervention group) which is newly diagnostic to be planned to receive capecitabine after finishing the standard adjuvant treatment or observation (control group) within 4 weeks after completion of standard adjuvant chemotherapy.

Conditions

Triple -Negative Breast Cancer

Keywords

early stage breast cancer triple negative

Outcome Measures

Primary Outcomes (1)

• adverse effents of capictabine

  assess the adverse effects of the Capecitabine 6 months after starting treatment.

Secondary Outcomes (2)

• distant disease-free survival

  up to 24 months from diagnosis

• overall survival

  24 months from diagnosis

Study Arms (2)

receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr

EXPERIMENTAL

Drug: capecitabine

No Intervention: observation after finishing the standard adjuvant treatment

NO INTERVENTION

Interventions

capecitabine DRUG

capecitabine 650 mg / m2 twice per day for one year

Also known as: xeloda

receive low-dose capecitabine maintenance within 4 weeks of finishing the standard adjuvant tr

Eligibility Criteria

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

You may qualify if:

• Eligible trial participants will women who has pathologically confirmed invasive breast ductal carcinoma Hormone receptor negative (\<1% positive cells by immunohistochemistry staining) and ERBB2 negative.
• Participants had early-stage tumors that were stage T1b-3N0-3cM0, without positive supraclavicular or internal mammary lymph node.
• They received standard treatments, including modified radical mastectomy or breast-conserving surgery, neo-/adjuvant chemotherapy, and radiotherapy according to institutional guidelines.
• patients were able to swallow tablets
• performance status 0 - 1

You may not qualify if:

• Lactation or pregnancy; or severe coexisting illness.

Sponsors & Collaborators

• Beni-Suef University: lead

Study Sites (1)

Faculty of Medicine

Banī Suwayf, Egypt

Location

MeSH Terms

Conditions

Triple Negative Breast Neoplasms

Interventions

Capecitabine

Condition Hierarchy (Ancestors)

Breast Neoplasms; 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

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: assistant lecturer of clinical oncology

Study Record Dates

• First Submitted: August 9, 2025
• First Posted: August 27, 2025
• Study Start: November 1, 2021
• Primary Completion: December 30, 2024
• Study Completion: May 30, 2025
• Last Updated: August 27, 2025

Record last verified: 2025-08

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP
• Time Frame: Total follow up of the study is 2 years, one year for drug receving with monthy follow up for adverse effect and the other year for every 3 months follow up to asses DFS and OS.
• Access Criteria: for oncologists

Locations

EG (1)