Efficacy of Capecitabine With Adjuvant Radiotherapy in Treatment of Early Stages Breast Cancer (Retrospective Study).
1 other identifier
observational
47
0 countries
N/A
Brief Summary
1- Determine the efficacy and safety of concurrent capecitabine and external beam irradiation in patients with early stages breast cancer.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for all trials
Started Apr 2023
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
March 23, 2021
CompletedFirst Posted
Study publicly available on registry
March 25, 2021
CompletedStudy Start
First participant enrolled
April 1, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
April 1, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2023
CompletedFebruary 1, 2023
January 1, 2023
Same day
March 23, 2021
January 30, 2023
Conditions
Outcome Measures
Primary Outcomes (1)
Disease free survival
Disease free survival
baseline
Interventions
Capecitabine with adjuvant radiotherapy in treatment of Early Stages Breast Cancer
Eligibility Criteria
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
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Central Study Contacts
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