search
Back to results

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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
FEC-100
Sponsored by
Assiut University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer

Eligibility Criteria

18 Years - 69 Years (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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

Sites / Locations

  • Assiut University Hospital

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

Retros FEC-100 +BRS

PROS 30 FEC-100 +BRS

Arm Description

Contains record of already treated patients with six cycles of FEC-100 Fluorouracil ,Epirubicin and Cyclophosphamide and later had Breast conservative Surgery(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

Outcomes

Primary Outcome Measures

Tumour size measurement
Measurement of tumuor size before and after six courses of FEC-100

Secondary Outcome Measures

Full Information

First Posted
October 3, 2018
Last Updated
October 3, 2018
Sponsor
Assiut University
search

1. Study Identification

Unique Protocol Identification Number
NCT03696004
Brief Title
Outcome of Neo-adjuvant Chemotherapy Followed by Breast Conservative Surgery in Breast Cancer in Upper Egypt
Official Title
Outcome of Neo-adjuvant Chemotherapy Followed by Breast Conservative Surgery in Breast Cancer in Upper Egypt
Study Type
Interventional

2. Study Status

Record Verification Date
May 2018
Overall Recruitment Status
Unknown status
Study Start Date
December 2018 (Anticipated)
Primary Completion Date
June 2019 (Anticipated)
Study Completion Date
December 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Assiut University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2, Phase 3
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Retros FEC-100 +BRS
Arm Type
Active Comparator
Arm Description
Contains record of already treated patients with six cycles of FEC-100 Fluorouracil ,Epirubicin and Cyclophosphamide and later had Breast conservative Surgery(BRS)
Arm Title
PROS 30 FEC-100 +BRS
Arm Type
Active Comparator
Arm Description
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
Intervention Type
Drug
Intervention Name(s)
FEC-100
Other Intervention Name(s)
Breast Conservative Surgery
Intervention Description
Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks
Primary Outcome Measure Information:
Title
Tumour size measurement
Description
Measurement of tumuor size before and after six courses of FEC-100
Time Frame
18 WEEKS

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Female patients diagnosed with breast cancer
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
69 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Sammani A Muhammad, MBBCh
Phone
+201111971589
Email
sammaniali66@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Mohamed K Ewies, PhD
Phone
+201001808518
Email
mohamed5korany@aun.edu.eg
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Hisham A Riad, PhD
Organizational Affiliation
Assiut University
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Samir S Mohamed, PhD
Organizational Affiliation
Assiut University
Official's Role
Study Director
Facility Information:
Facility Name
Assiut University Hospital
City
Assiut
ZIP/Postal Code
71515
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
21940138
Citation
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.
Results Reference
background
PubMed Identifier
21177208
Citation
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.
Results Reference
background
PubMed Identifier
16125064
Citation
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.
Results Reference
background
PubMed Identifier
12401904
Citation
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.
Results Reference
background
PubMed Identifier
11839324
Citation
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.
Results Reference
background
PubMed Identifier
29326104
Citation
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.
Results Reference
background
PubMed Identifier
22275993
Citation
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.
Results Reference
result
PubMed Identifier
12196717
Citation
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.
Results Reference
result

Learn more about this trial

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

We'll reach out to this number within 24 hrs