Outcome of Neo-adjuvant Chemotherapy Followed by Breast Conservative Surgery in Breast Cancer in Upper Egypt

Study Overview
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Brief Summary
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Systemic chemotherapy along with radiotherapy has been successfully used to post-operatively manage patients following tumour resection in breast cancer. This was further supported with clinical trials conducted in the 1970s and 1980s which shows significant improvement in progression-free of tumours and overall survival rates in patients who undergo chemotherapy for operable breast cancer.(1)-(2) Neoadjuvant chemotherapy on the other hand, involves the administration of the chemotherapeutic agents some weeks before appropriate breast surgery. This induces reduction in the tumour size and allows for breast conservative surgery instead of mastectomy in some cases. Techniques for tumour localization in neoadjuvant chemotherapy using metallic markers allowing lower excision of breast tissue without compromising margins and breast conservation being feasible in many patients have evolved over time.(3)-(7)-(9) However, there are recent concerns questioning the increase use of neoadjuvant chemotherapy in breast cancer it as it may not be beneficial to patients in the long run.(10)

Detailed Description
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This will consist of six cycles of FEC-100 regimen followed by surgery. The decision on the type of surgery (breast conservative surgery or mastectomy) will be taken on the final assessment of the disease after the six cycle. Neoadjuvant chemotherapy regimen will consist of six cycles of fluorouracil 500mg/m2 , epirubicin 75mg/m2 and cyclophosphamide 500mg/m2 administered intravenously at three week interval. Surgery was planned to be performed within 4-6 weeks after the six course of chemotherapy.

Official Title
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Outcome of Neo-adjuvant Chemotherapy Followed by Breast Conservative Surgery in Breast Cancer in Upper Egypt

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: FEC-100


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria:1- female patients diagnosed with breast cancer and are attending oncology or surgical unit of Assiut university hospital . 2- breast cancer will be diagnosed by core-needle biopsy. 3- all patients must have complete history and physical examination (including careful assessment of breast and axillary lymph nodes). 4- All patients must have routine laboratory tests (CBC, liver and renal function tests, and alkaline phosphatase) and radiological tests (chest x-ray, pelvic-abdominal ultrasound, bilateral mammography with confirmatory ultrasound and complete echocardiography to assess the cardiac function). 5- written consent from patients. - Exclusion Criteria: 1- Elderly patients more than 70years old. 2- Previous treatment for breast cancer. 3- Presence of co-existing malignancies. 4- Pregnancy or lactation at time of diagnosis. 5- Severe renal, hepatic or haematological abnormalities. 6- Bilateral breast cancer. 7- advanced breast cancer

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 69 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Retros FEC-100 +BRS<br>Contains record of already treated patients with six cycles of FEC-100 Fluorouracil ,Epirubicin and Cyclophosphamide and later had Breast conservative Surgery(BRS) | Drug: FEC-100<br>* Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks<br>* Other names: Breast Conservative Surgery;|
| Active Comparator: PROS 30 FEC-100 +BRS<br>These are new patients who will be treated with six cycles of FEC-100 (Flourouracil,Epirubicin and Cyclophosphamide) and will undergo Breast Conservative Surgery (BRS)after 6 weeks | Drug: FEC-100<br>* Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks<br>* Other names: Breast Conservative Surgery;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Tumour size measurement | Measurement of tumuor size before and after six courses of FEC-100 | 18 WEEKS |