Concurrent Paclitaxel and Radiotherapy After Adjuvant Doxorubicin and Cyclophosphamide for Stage 2 or 3 Breast Cancer

NCT04809844 | Unknown

• 1 other identifier: Breast cancer in females
• Study Type: observational
• Target: 46
• Locations: 0 countries
• Sites: N/A

Brief Summary

The aim of this study is Evaluation of the efficacy \& toxicity of concurrent paclitaxel and breast radiotherapy and assesment of overall survival \& progression free survival

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Toxicity of concurrent paclitaxel & breast radiotherapy such as acute skin toxicities .

  Acute skin toxicities will be graded by using a scale ranging from 0-4 where 0= no change ,1= follicular, faint or dull erythema/epilation/ dry desquamation , 2= tender or bright erythema , 3= confluent moist desquamation , pitting edema , 4= ulceration , hemorrhage , necrosis .

  baseline

Interventions

Concurrent chemoradiation OTHER

concurrent Paclitaxel and radiation therapy after Adjuvant doxorubicin and Cyclophosphamide chemotherapy for stage ll or lll breast cancer .

Eligibility Criteria

• Age: 18 Years+
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

This study will include female patients with stage II-lll breast cancer who underwent conservative breast surgery \& modified radical mastectomy

You may qualify if:

• This study will include women aged 18 years \&older.
• patients must be histologically diagnosed with breast cancer (ductal \& others).
• patients who underwent conservative breast surgery \& modified radical mastectomy.
• patients with stage ll\&lll breast cancer.
• patients who received (AC) as adjuvant treatment .

You may not qualify if:

• patients with stage 1 or 4 breast cancer.
• patients received adjuvant chemotherapy rather than (AC) .
• patients with prior irradiation with thoracic region .
• pregnancy or lactation .
• patient with serious comorbid disease such as chronic obstructive pulmonary disease .

Sponsors & Collaborators

• Assiut University: lead

Related Publications (4)

• Ghoncheh M, Pournamdar Z, Salehiniya H. Incidence and Mortality and Epidemiology of Breast Cancer in the World. Asian Pac J Cancer Prev. 2016;17(S3):43-6. doi: 10.7314/apjcp.2016.17.s3.43.

  PMID: 27165206 BACKGROUND

• Olivotto IA, Bajdik CD, Plenderleith IH, Coppin CM, Gelmon KA, Jackson SM, Ragaz J, Wilson KS, Worth A. Adjuvant systemic therapy and survival after breast cancer. N Engl J Med. 1994 Mar 24;330(12):805-10. doi: 10.1056/NEJM199403243301201.

  PMID: 8114832 BACKGROUND

• Abal M, Andreu JM, Barasoain I. Taxanes: microtubule and centrosome targets, and cell cycle dependent mechanisms of action. Curr Cancer Drug Targets. 2003 Jun;3(3):193-203. doi: 10.2174/1568009033481967.

  PMID: 12769688 BACKGROUND

• Ali Hassan A, Ibrahim NY, Jassen MAR. Concurrent Paclitaxel and Radiotherapy for Node Positive Breast Cancer. Gulf J Oncolog. 2019 Jan;1(29):14-21.

  PMID: 30956192 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

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

Study Design

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

Study Record Dates

• First Submitted: March 13, 2021
• First Posted: March 22, 2021
• Study Start: September 1, 2023
• Primary Completion: November 1, 2023
• Study Completion: December 1, 2023
• Last Updated: October 18, 2022

Record last verified: 2022-10