Clinical trial NCT04809844: Concurrent Paclitaxel and Radiotherapy After Adjuvant Doxorubicin and Cyclophosphamide for Stage 2 or 3 Breast Cancer
Official title: Retrospective Study of Concurrent Paclitaxel and Radiation Therapy After Adjuvant Doxorubicin and Cyclophosphamide Chemotherapy for Stage 2 or 3 Breast Cancer
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Breast Cancer
Lead sponsor: Assiut University
Sponsor class: OTHER
First posted: 2021-03-22
Enrollment: 46
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: OTHER
Time perspective: RETROSPECTIVE
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

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.

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 .

Primary outcomes:
measure: Toxicity of concurrent paclitaxel & breast radiotherapy such as acute skin toxicities .
timeFrame: baseline
Secondary outcomes:
Other outcomes:
Locations:
Study officials:
References:
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. doi: 10.7314/apjcp.2016.17.s3.43.
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. doi: 10.1056/NEJM199403243301201.
citation: 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.
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.