NCT05150535

Brief Summary

  • Cancer is the second leading cause of death after cerebrovascular strokes and is a significant obstacle to each nation's future growth.
  • Worldwide, Breast cancer is the most common cancer in women and the 5th leading cause of cancer related deaths that comes after lung cancer, colorectal cancer, liver cancer and gastric cancer.
  • More than half of all breast cancer cases in the world occur in developing countries. Egypt has a high mortality rate from breast cancer, with a rate of 21.3 per 100,000 cases. Breast cancer is diagnosed at an advanced stage in 60 to 70% of cases in Egypt. The median age at diagnosis in Egypt is 48.5 years, which seems to be a decade younger than in Europe and North America.

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
100

participants targeted

Target at P50-P75 for not_applicable

Timeline
Completed

Started Oct 2021

Typical duration for not_applicable

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

Study Start

First participant enrolled

October 1, 2021

Completed
1 month until next milestone

First Submitted

Initial submission to the registry

November 3, 2021

Completed
1 month until next milestone

First Posted

Study publicly available on registry

December 9, 2021

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

October 1, 2023

Completed
Last Updated

May 9, 2022

Status Verified

May 1, 2022

Enrollment Period

2 years

First QC Date

November 3, 2021

Last Update Submit

May 5, 2022

Conditions

Breast Carcinoma

Outcome Measures

Primary Outcomes (4)

  • Acute toxicity

    Rate of acute grade 2 toxicity or higher from the treatment till 3 months (NCI\_CTCAE). Each patient will be assesed weekly during radiotherapy and monthly for 3 months post radiotherapy.

    3 months

  • Chronic toxicity

    Rate of chronic toxicity grade 2 or higher ( NCI\_CTCAE) from 6 months after radiotherapy up to 2 years. Each patient will be assessed before treatment and at 6,12 and 24 months from treatment.

    6 months post treatment up to 2 years

  • Local recurrence

    Rate of ipsilateral locoregional tumor recurrence proved by imaging and biopsy.

    Up to 2 years

  • Patient compliance

    Compliance to treatment (number of interrupted days of radiotherapy.

    From the starting point of treatment till the end of treatment ( 3 weeks in control arm and 1 week in experimental arm

Secondary Outcomes (1)

  • Overall survival

    From time of diagnosis up to 2 years post radiotherapy

Study Arms (2)

Hypofractionation control arm

ACTIVE COMPARATOR

Patients who will receive 40 Gy in 15 fractions to the entire breast or chest wall over three weeks and have had breast conservation surgery (BCS) or oncoplastic breast surgery(OBS) will receive an additional boost to the tumour site if and will receive sequential dose 12GY\\4 fractions or SIB 8GY 15 fractions. The supraclavicular fossa will be treated in patients with node-positive disease or those who had received neoadjuvant chemotherapy . The IMLN will be irradiated in N2and N3 at first presentation.

Radiation: Hypofractionation Radiotherapy.

. Ultrahypofractionation experimental arm

EXPERIMENTAL

Patients who will receive 26 Gy in 5 fractions to the entire breast and or chest wall for one week only. The volume of this arm will be the same as the volume of the control arm as regard axillary nodes, supraclavicular and IMLN. Patients who have had breast conservation or oncoplastic breast surgery(OBS) will be given a boost. If a boost is given, SIB of 6 Gy in 5 fractions will be used (or a sequential boost of 12GY\\4 fractions).

Radiation: Ultra-hypofractionation radiotherapy

Interventions

Hypofractionation Radiotherapy.RADIATION

Patients will receive 40 Gy in 15 fractions to the entire breast and or chest wall over the course of 3 weeks.

Also known as: 3 weeks radiotherapy.
Hypofractionation control arm
Ultra-hypofractionation radiotherapyRADIATION

Patients will receive 26 Gy in 5 fractions to the entire breast and or chest wall over the course of one week.

Also known as: 1 week accelerated hypo-fractionation radiotherapy
. Ultrahypofractionation experimental arm

Eligibility Criteria

Age45 Years - 85 Years
Sexfemale(Gender-based eligibility)
Gender Eligibility Detailsfemale adult patients with breast
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Female patients 45 years of age or older who have had Oncoplastic Breast Surgery (OBS) or total mastectomy with adequate axillary clearance and a negative margin.
  • Breast carcinomas that is invasive (TXN1-3M0, T0N2-3 M0, T1N2-3M0, T2N2-3M0, T3N0-3M0, T4N0-3M0) whatever type of tumors biology.
  • All patients with locally advanced breast cancer who received neoadjuvant chemotherapy and underwent either oncoplastic breast surgery or modified radical mastectomy

You may not qualify if:

  • Metastatic breast cancer at the time of diagnosis proved clinically or radiologically.
  • Postoperative positive margin.
  • Carcinomas in situ.
  • Mesenchymal breast lesions.
  • Locoregional recurrent breast cancer.
  • Synchronous bilateral breast cancer.
  • very early breast cancer (T1-2N0M0,T1N1M0).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Sohag University Hospital

Sohag, Egypt

RECRUITING

Related Publications (4)

  • Sung H, Ferlay J, Siegel RL, Laversanne M, Soerjomataram I, Jemal A, Bray F. Global Cancer Statistics 2020: GLOBOCAN Estimates of Incidence and Mortality Worldwide for 36 Cancers in 185 Countries. CA Cancer J Clin. 2021 May;71(3):209-249. doi: 10.3322/caac.21660. Epub 2021 Feb 4.

    PMID: 33538338BACKGROUND

  • Gany F, Ayash C, Raad N, Wu M, Roberts-Eversley N, Mahmoud H, Fouad Y, Fahmy Y, Asar H, Salama A, El-Shinawi M. Financial and food security challenges of Egyptian women undergoing breast cancer treatment. Support Care Cancer. 2020 Dec;28(12):5787-5794. doi: 10.1007/s00520-020-05426-9. Epub 2020 Mar 27.

    PMID: 32221669BACKGROUND

  • Momenimovahed Z, Salehiniya H. Epidemiological characteristics of and risk factors for breast cancer in the world. Breast Cancer (Dove Med Press). 2019 Apr 10;11:151-164. doi: 10.2147/BCTT.S176070. eCollection 2019.

    PMID: 31040712BACKGROUND

  • Stapleton SM, Oseni TO, Bababekov YJ, Hung YC, Chang DC. Race/Ethnicity and Age Distribution of Breast Cancer Diagnosis in the United States. JAMA Surg. 2018 Jun 1;153(6):594-595. doi: 10.1001/jamasurg.2018.0035.

    PMID: 29516087BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiation Dose HypofractionationRadiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Dose Fractionation, RadiationRadiotherapy DosageTherapeutics

Central Study Contacts

Nahla M Elmahdy, assistant lecturer

CONTACT

01026886840nahla.youssif@med.sohag.edu.eg

Mohamed S gaber, professor

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant lecturer of clinical oncology sohag university hospitals

Study Record Dates

First Submitted

November 3, 2021

First Posted

December 9, 2021

Study Start

October 1, 2021

Primary Completion

October 1, 2023

Study Completion

October 1, 2023

Last Updated

May 9, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will share

Locations

EG(1)