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

Assiut University

Status: Not yet enrolling

Conditions: Breast Cancer

Treatments: Other: Concurrent chemoradiation

Study type: Observational

Funder types: Other

Identifiers

NCT04809844

Breast cancer in females

Details and patient eligibility

About

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

Full 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.

Enrollment: 46 estimated patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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 .