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Clinical Trial 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)

Clinical Trial 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 Design

Related Conditions & MeSH terms

NCT number NCT03696004
Study type Interventional
Source Assiut University
Contact Sammani A Muhammad, MBBCh
Phone +201111971589
Status Not yet recruiting
Phase Phase 2/Phase 3
Start date December 2018
Completion date December 2020

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