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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04809844
• Other study ID #: Breast cancer in females
• Status: Not yet recruiting
• Start date: September 2023
• Est. completion date: December 2023

Study information

• Verified date: October 2022
• Source: Assiut University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 46
• Est. completion date: December 2023
• Est. primary completion date: November 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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 .

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Other:
• Concurrent chemoradiation
concurrent Paclitaxel and radiation therapy after Adjuvant doxorubicin and Cyclophosphamide chemotherapy for stage ll or lll breast cancer .

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Assiut University

References & Publications (4)

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. Review. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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