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

NCT ID: NCT04809844

Last Updated: 2022-10-18

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 46 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2023-09-30
• Study Completion Date: 2023-12-31

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

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.

Conditions

Breast Cancer

Study Design

• Observational Model Type: OTHER
• Study Time Perspective: RETROSPECTIVE

Interventions

Concurrent chemoradiation

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

Intervention Type: OTHER

Eligibility Criteria

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 .

• Minimum Eligible Age: 18 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Hoda Gamal Boraey

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

References

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.

Reference Type: BACKGROUND

PMID: 27165206 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 8114832 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 12769688 (View on PubMed)

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.

Reference Type: BACKGROUND

PMID: 30956192 (View on PubMed)

Other Identifiers

Breast cancer in females

Identifier Type: -

Identifier Source: org_study_id