drugset / Trial / NCT03696004

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

NCT03696004

Phase 2/3 Unknown 45 enrolled Assiut University
RandomizedSingle-groupOpen-labelTreatment

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)

Timeline

Start
2018-12
Primary completion
2019-06
Completion
2020-12

Publications

Drugs

EvaluationDrugModalityDoseRoute
Comparator Cyclophosphamide Other / unclassified 500 mg/m2 Intravenous
Comparator Epirubicin Small molecule 75 mg/m2 Intravenous
Comparator fluorouracil Small molecule 500 mg/m2 Intravenous

Indications