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

Phase 2

• Conditions: Breast Cancer
• Interventions: Drug: FEC-100

• Registration Number: NCT03696004
• Lead Sponsor: Assiut University

Brief Summary

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

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.

Study Timeline

• Status Verified: 2018-05
• Study First Submitted: 2018-10-03
• Study First Submitted QC: 2018-10-03
• Last Update Submitted: 2018-10-03
• Study First Posted: 2018-10-04
• Last Update Posted: 2018-10-04
• Study Start: 2018-12
• Primary Completion: 2019-06
• Study Completion: 2020-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 45

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Retros FEC-100 +BRS	FEC-100	Contains record of already treated patients with six cycles of FEC-100 Fluorouracil ,Epirubicin and Cyclophosphamide and later had Breast conservative Surgery(BRS)
PROS 30 FEC-100 +BRS	FEC-100	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

Primary Outcome Measures

Name	Time	Method
Tumour size measurement	18 WEEKS	Measurement of tumuor size before and after six courses of FEC-100

Trial Locations

Locations (1)

Assiut University Hospital; 🇪🇬 Assiut, Egypt