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

Retrospective Study of Concurrent Paclitaxel and Radiation Therapy After Adjuvant Doxorubicin and Cyclophosphamide Chemotherapy for Stage 2 or 3 Breast Cancer

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

Study Overview

• Status: Not yet recruiting
• Conditions: Breast Cancer
• Intervention / Treatment: Other: Concurrent chemoradiation

Detailed Description

Over the recent years , breast cancer remains the most common cancer in women in the world . With nearly 107 Million new Cases diagnosed in 2012 (second most common cancer over all) . this represent about 12 % of all new cancer cases and 25 % of all cancers in women . By contrast the mortality rate has declined dramatically since the introduction of adjuvant systemic therapy & radiation therapy, which are now used extensively for their established benefit in local (radiotherapy ) ,survival without metastasis (chemotherapy) and overall survival of both of them . However , the optimal sequence of chemotherapy & radiotherapy remain controversial three sequence were investigated:

1. Delivering all radiotherapy first .
2. A " Sandwich " approach .
3. Delivering all chemotherapy first . Observational studies have suggested that delaying initiation of chemotherapy increase the incidence of distant metastasis & delaying the initiation therapy more than 6 months after breast cancer diagnosis might increase risk of local regional recurrence . Concurrent chemoradiation therapy has an advantage of shortening the duration of therapy , allowing radiotherapy & chemotherapy to start temporally and potentially improving local control via radiation sensitizing effect of chemotherapy.The feasibility of concurrent radiotherapy with taxane, which constitute a standard treatment used as adjuvant therapy has been evaluated in stage II,III breast cancer. Taxane Promote stabilization of microtubules causing cell cycle arrest in G2/M junction and serve as radio sensitizing agents.In a prospective study using Paclitaxel & radiotherapy concurrently Paclitaxel given every 3 weeks for 4 cycles the authors concluded that Concurrent chemoradiation therapy improve local control with acceptable toxicity.

• Study Type: Observational
• Enrollment (Anticipated): 46

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (ADULT, OLDER_ADULT)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

Inclusion criteria :

• • 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 .

Exclusion Criteria:

• 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 .

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (ANTICIPATED): September 1, 2023
• Primary Completion (ANTICIPATED): November 1, 2023
• Study Completion (ANTICIPATED): December 1, 2023

Study Registration Dates

• First Submitted: March 13, 2021
• First Submitted That Met QC Criteria: March 18, 2021
• First Posted (ACTUAL): March 22, 2021

Study Record Updates

• Last Update Posted (ACTUAL): October 18, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: Breast cancer in females

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No