NCT03696004

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)

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
45

participants targeted

Target at P25-P50 for phase_2 breast-cancer

Timeline
Completed

Started Dec 2018

Shorter than P25 for phase_2 breast-cancer

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 3, 2018

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 4, 2018

Completed
2 months until next milestone

Study Start

First participant enrolled

December 1, 2018

Completed
6 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2019

Completed
1.5 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2020

Completed
Last Updated

October 4, 2018

Status Verified

May 1, 2018

Enrollment Period

6 months

First QC Date

October 3, 2018

Last Update Submit

October 3, 2018

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

  • Tumour size measurement

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

    18 WEEKS

Study Arms (2)

Retros FEC-100 +BRS

ACTIVE COMPARATOR

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

Drug: FEC-100

PROS 30 FEC-100 +BRS

ACTIVE COMPARATOR

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

Drug: FEC-100

Interventions

FEC-100DRUG

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

Also known as: Breast Conservative Surgery
PROS 30 FEC-100 +BRSRetros FEC-100 +BRS

Eligibility Criteria

Age18 Years - 69 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility DetailsFemale patients diagnosed with breast cancer
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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).
  • 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).
  • written consent from patients.

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Assiut University Hospital

Asyut, 71515, Egypt

Location

Related Publications (8)

  • 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.

    PMID: 21940138BACKGROUND

  • 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.

    PMID: 21177208BACKGROUND

  • 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.

    PMID: 16125064BACKGROUND

  • 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.

    PMID: 12401904BACKGROUND

  • 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.

    PMID: 11839324BACKGROUND

  • 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.

    PMID: 29326104BACKGROUND

  • 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.

    PMID: 22275993RESULT

  • 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.

    PMID: 12196717RESULT

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Hisham A Riad, PhD

    Assiut University

    STUDY CHAIR

  • Samir S Mohamed, PhD

    Assiut University

    STUDY DIRECTOR

Central Study Contacts

Sammani A Muhammad, MBBCh

CONTACT

+201111971589sammaniali66@gmail.com

Mohamed K Ewies, PhD

CONTACT

+201001808518mohamed5korany@aun.edu.eg

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
General Surgery Resident

Study Record Dates

First Submitted

October 3, 2018

First Posted

October 4, 2018

Study Start

December 1, 2018

Primary Completion

June 1, 2019

Study Completion

December 1, 2020

Last Updated

October 4, 2018

Record last verified: 2018-05

Data Sharing

IPD Sharing
Will not share

Locations

EG(1)