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

Sponsor:

Collaborators:

Information provided by (Responsible Party):

Sammani Ali Muhammad，Assiut University

Tracking Information

First Submitted Date ^ICMJE

October 3, 2018

First Posted Date ^ICMJE

October 4, 2018

Last Update Posted Date

October 4, 2018

Actual Study Start Date ^ICMJE

December 2018

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Tumour size measurement[ Time Frame: 18 WEEKS ]

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

Original Primary Outcome Measures ^ICMJE

Same as current

Current Secondary Outcome Measures ^ICMJE

[ Time Frame: ]

Descriptive Information

Brief Title ^ICMJE

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

Official Title ^ICMJE

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

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 Type ^ICMJE

Interventional

Study Phase

Phase 2/Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Single Group Assignment
Intervention Model Description:
Masking: Interventional
Masking Description:
Primary Purpose: Treatment

Condition ^ICMJE

Intervention ^ICMJE

Drug: FEC-100
Patients will recieve six cycles of FEC-100 and Breast conservative surgery after 4-6 weeks

Study Arms

Active Comparator: 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)
Active Comparator: 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

Recruitment Information

Recruitment Status ^ICMJE

Not yet recruiting

Estimated Enrollment ^ICMJE

Original Estimated Enrollment ^ICMJE

Same as current

Estimated Study Completion Date

December 2020

Estimated Primary Completion Date

June 2019 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

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

Sex/Gender

Sexes Eligible for Study:

Female

Ages

18 Years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Listed Location Countries ^ICMJE

Egypt

Removed Location Countries

Administrative Information

Has Data Monitoring Committee

Yes

U.S. FDA-regulated Product

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No

IPD Sharing Statement

Plan to Share IPD:

Responsible Party

Sammani Ali Muhammad，Assiut University

Study Sponsor ^ICMJE

Assiut University

Collaborators ^ICMJE

Investigators ^ICMJE

Study Chair: Hisham A Riad, PhD Assiut University
Study Director: Samir S Mohamed, PhD Assiut University

PRS Account

Assiut University

Verification Date

May 2018

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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