NCT04815616

Brief Summary

1- Determine the efficacy and safety of concurrent capecitabine and external beam irradiation in patients with early stages breast cancer.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
47

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2023

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 23, 2021

Completed
2 days until next milestone

First Posted

Study publicly available on registry

March 25, 2021

Completed
2 years until next milestone

Study Start

First participant enrolled

April 1, 2023

Completed
Same day until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

April 1, 2023

Completed
Last Updated

February 1, 2023

Status Verified

January 1, 2023

Enrollment Period

Same day

First QC Date

March 23, 2021

Last Update Submit

January 30, 2023

Conditions

Outcome Measures

Primary Outcomes (1)

  • Disease free survival

    Disease free survival

    baseline

Interventions

RadiotherapyRADIATION

Capecitabine with adjuvant radiotherapy in treatment of Early Stages Breast Cancer

Eligibility Criteria

Age18 Years - 75 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Early stage breast cancer Patients who received adjuvant Radiotherapy with capecitabine .

You may qualify if:

  • Age of patients ≥ 18 years old patients.
  • Histopathology confirmed: invasive ductal carcinoma.
  • Breast conservative surgery or mastectomy.
  • Early stage breast cancer patients.
  • Adjuvant chemotherapy in the form of Anthracyclins based.

You may not qualify if:

  • Contraindications to radiotherapy: such as previous irradiation to chest wall or skin diseases.
  • Pregnancy or lactation.
  • Contraindications to capecitabine such as: severe renal impairment Or hypersensitivity to capecitabine.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (1)

  • 1-. American Cancer society. .American cancer society. Cancer facts and figures 2021.available at: How common is breast cancer/ Jan 2021. http://www.cancer.org/content/dam/cancer-org/research/cancer-fact and ststics /annual- cancer-facts-and figures -2021.pdf. 2- stackievicz R ,Paran H ,Bernhiem J, et al. Prognostic significance of HER-2 /neu expression in patients with ductal carcinoma in situ. Isr med assoc j 2010 ;12:290-295 available at : http://www.ncbi.nlm.nih.gov,pubmed/20929083. 3-. early breast cancer trialists collaborative G, Darby S,Mc Gale P,et al. effect of radiotherapy after breast conserving surgery on 10-year recurrence and 15- year breast cancer death :meta-analysis of individual patients data for 10,801 women in 17 randomized trials .Lancet 2011;378:1707-1716 Available at: http:// www.ncbi.nlm.nih.gov,pubmed/22019144. 4-.early breast cancer trialists collaborative G, Darby S,Mc Gale P,et al. effect of radiotherapy after mastectomy and axillary surgery on 10- year recurrence and 20-year breast cancer mortality :meta-analysis individual patients data for 8135 women in 22 randomized trials. Lancet 2014; 383:2127-2135 available at: http:// www.ncbi.nlm.nih.gov,pubmed/24656685. 5-.Chargari C,Kirova YM,Laki F, et al. the impact of loco regional treatment in elderly breast cancer patients :hypo -fractionated exclusive radiotherapy, single institution long term results .breast 2010 ;19;413-6. 6-.Karasawa K,Saito M, Hariwatari H et al. the role of chemo radiotherapy in patients with unresectable T4 breast tumors breast cancer 2013;20:254-61. 7- N Engl J Med 2017; 376:2147-2159

    BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

Seham Adel Ali, Master degree

CONTACT

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal investigator

Study Record Dates

First Submitted

March 23, 2021

First Posted

March 25, 2021

Study Start

April 1, 2023

Primary Completion

April 1, 2023

Study Completion

April 1, 2023

Last Updated

February 1, 2023

Record last verified: 2023-01