Outcome of Neo-adjuvant Chemotherapy Followed by Breast Conservative Surgery in Breast Cancer in Upper Egypt
NCT ID: NCT03696004
Last Updated: 2018-10-04
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
UNKNOWN
PHASE2/PHASE3
45 participants
INTERVENTIONAL
2018-12-31
2020-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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)
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Outcomes of Breast Conservative Surgery for Post Chemotherapy Tumour Size After Response to Neoadjuvant Chemotherapy
NCT05115279
Accelerated Hypofractionated 1 Week Radiotherapy in Breast Cancer Patients
NCT05591456
Evaluating New Surgical Technique in Management of Female Patients With Operable Multifocal Breast Cancer
NCT03900299
Oncological Safety of Oncoplastic Breast Surgery in Multicentric Breast Cancer
NCT06926335
Conventional Versus Hypofractionated Radiotherapy in Node Positive Breast Cancer
NCT02690636
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
SINGLE_GROUP
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Retros FEC-100 +BRS
Contains record of already treated patients with six cycles of FEC-100 Fluorouracil ,Epirubicin and Cyclophosphamide and later had Breast conservative Surgery(BRS)
FEC-100
Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks
PROS 30 FEC-100 +BRS
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
FEC-100
Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
FEC-100
Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
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
18 Years
69 Years
FEMALE
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Assiut University
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Sammani Ali Muhammad
General Surgery Resident
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Hisham A Riad, PhD
Role: STUDY_CHAIR
Assiut University
Samir S Mohamed, PhD
Role: STUDY_DIRECTOR
Assiut University
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Assiut University Hospital
Asyut, , Egypt
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
References
Explore related publications, articles, or registry entries linked to this study.
Espinosa-Bravo M, Sao Aviles A, Esgueva A, Cordoba O, Rodriguez J, Cortadellas T, Mendoza C, Salvador R, Xercavins J, Rubio IT. Breast conservative surgery after neoadjuvant chemotherapy in breast cancer patients: comparison of two tumor localization methods. Eur J Surg Oncol. 2011 Dec;37(12):1038-43. doi: 10.1016/j.ejso.2011.08.136. Epub 2011 Sep 21.
Bobin JY, Al-Khaledi K, Ahmad J. Breast conservative surgery for operable invasive ductal carcinoma after neoadjuvant chemotherapy or hormonal therapy- a challenge for breast surgeon: a review based on literature and experience. Gulf J Oncolog. 2011 Jan;(9):45-51.
Schwartz GF, Meltzer AJ, Lucarelli EA, Cantor JP, Curcillo PG 2nd. Breast conservation after neoadjuvant chemotherapy for stage II carcinoma of the breast. J Am Coll Surg. 2005 Sep;201(3):327-34. doi: 10.1016/j.jamcollsurg.2005.03.015.
Van Praagh I, Cure H, Leduc B, Charrier S, Le Bouedec G, Achard JL, Ferriere JP, Feillel V, De Latour M, Dauplat J, Chollet P. Efficacy of a primary chemotherapy regimen combining vinorelbine, epirubicin, and methotrexate (VEM) as neoadjuvant treatment in 89 patients with operable breast cancer. Oncologist. 2002;7(5):418-23. doi: 10.1634/theoncologist.7-5-418.
Kuerer HM, Singletary SE, Buzdar AU, Ames FC, Valero V, Buchholz TA, Ross MI, Pusztai L, Hortobagyi GN, Hunt KK. Surgical conservation planning after neoadjuvant chemotherapy for stage II and operable stage III breast carcinoma. Am J Surg. 2001 Dec;182(6):601-8. doi: 10.1016/s0002-9610(01)00793-0.
Vaidya JS, Massarut S, Vaidya HJ, Alexander EC, Richards T, Caris JA, Sirohi B, Tobias JS. Rethinking neoadjuvant chemotherapy for breast cancer. BMJ. 2018 Jan 11;360:j5913. doi: 10.1136/bmj.j5913. No abstract available.
Abdel-Bary N, El-Kased A, Aiad H. Does neoadjuvant chemotherapy increase breast conservation in operable breast cancer: an Egyptian experience. Ecancermedicalscience. 2009;3:104. doi: 10.3332/ecancer.2008.104. Epub 2009 Apr 9.
Inaji H, Komoike Y, Motomura K, Kasugai T, Sawai Y, Koizumi M, Nose T, Koyama H. Breast-conserving treatment after neoadjuvant chemotherapy in large breast cancer. Breast Cancer. 2002;9(1):20-5. doi: 10.1007/BF02967542.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
SAMuhammad
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.