Trial Comparing 3 Schedules of Hypofractionated Whole Breast Irradiation in Females With Early Stage Breast Cancer

NCT04148586 | Completed

• 1 other identifier: 201617090.3
• Study Type: interventional
• Target: 152
• Locations: 1 country
• Sites: 1

Brief Summary

The establishment of conservative breast surgery (CBS) and whole breast irradiation (WBI) as an alternative to mastectomy was a process that occurred over two to three decades. Based on the available evidence, hypofractionated WBI may be safely offered to most women with ductal carcinoma insitu (DCIS) or early-stage invasive breast cancer after CBS. This prospective randomized clinical trial aims to evaluate the outcomes of one-week and once weekly schedules of WBI against the investigator's standard hypofractionated WBI ( 40 Gy /15 fraction /3 weeks) in females with early stage breast cancer after CBS.

Conditions

Breast Cancer Female

Outcome Measures

Primary Outcomes (4)

• Acute toxicity

  The proportion of patients with grade ≥3 toxicity according to The Radiation Therapy Oncology Group (RTOG) morbidity scoring criteria.

  3 months from the start of whole breast irradiation

• Cosmetic outcome

  measured by The European Organisation for Research and Treatment of Cancer (EORTC) breast cosmetic rating system (observer rating)

  Annually after the end of whole breast irradiation for 5 years

• Ibsilateral locoregional tumor control

  must be confirmed by cytological/ histological assessment

  Annually after the end of whole breast irradiation for 5 years.

• patient-reported outcome measures (PROMs)

  measured by The European Organisation for Research and Treatment of Cancer, EORTC Quality of Life questionnaire for breast cancer patients ( EORTC QLQ-BR 23).

  Annually after the end of whole breast irradiation for 5 years.

Secondary Outcomes (3)

• late toxicity

  Annually after the end of whole breast irradiation for 5 years.

• Distant disease-free survival

  5 years from the initial diagnosis of breast cancer

• Overall survival

  5 years from the initial diagnosis of breast cancer

Study Arms (3)

One week Whole Breast Irradiation

EXPERIMENTAL

WBI: 27 Gy/5 fractions/1 week. 5.4 Gy /fraction ± boost to tumor bed 5.4 Gy/ 1 fraction, 2 days after the end of WBI.

Other: Whole Breast Irradiation

Once weekly Whole Breast Irradiation

EXPERIMENTAL

WBI: 28.5 Gy/ 5 fractions/ 5 weeks. 5.7 Gy/fraction ± boost to tumor bed 5.7 Gy/ 1 fraction, one week after the end of WBI. WBI is given on the same day each week.

Other: Whole Breast Irradiation

3 weeks Whole Breast Irradiation

ACTIVE COMPARATOR

WBI: 40.05 Gy/ 15 fractions/ 3 weeks. 2.67 Gy/ fraction ± boost to tumor bed 10 Gy/ 4 fraction / 4 days after the end of WBI

Other: Whole Breast Irradiation

Interventions

Whole Breast Irradiation OTHER

Whole Breast Irradiation after CBS in females with DCIS and early stage breast cancer

3 weeks Whole Breast Irradiation; Once weekly Whole Breast Irradiation; One week Whole Breast Irradiation

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Tis, pT1-2, pN0-1, M0 disease
• Invasive carcinoma of the breast or ductal carcinoma insitu \[DCIS\]
• CBS (reconstruction is not allowed)
• Negative surgical margin
• Axillary staging \&/or dissection

You may not qualify if:

• pT3-4, pN2-3 breast cancer
• Inadequate axillary lymph node dissection
• Neoadjuvant chemotherapy
• Non-epithelial breast malignancies such as sarcoma or lymphoma
• Synchronous bilateral invasive or non-invasive breast cancer
• History of invasive breast cancer or DCIS (Patients with a history of lobular carcinoma in situ (LCIS) treated by surgery alone are eligible.)
• Past history of malignancy except
• Basal cell skin cancer
• CIN cervix uteri
• Cosmetic breast implants (Patients who have had implants removed are eligible.)
• Prior breast or thoracic RT for any condition
• Collagen vascular disease, specifically systemic lupus, or scleroderma
• Pregnancy or lactation at the time of radiotherapy. Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy

Sponsors & Collaborators

• National Cancer Institute, Egypt: lead

Study Sites (1)

NCI. Cairo University

Cairo, 12345, Egypt

Location

Related Publications (5)

• Brunt AM, Wheatley D, Yarnold J, Somaiah N, Kelly S, Harnett A, Coles C, Goodman A, Bahl A, Churn M, Zotova R, Sydenham M, Griffin CL, Morden JP, Bliss JM; FAST-Forward Trial Management Group. Acute skin toxicity associated with a 1-week schedule of whole breast radiotherapy compared with a standard 3-week regimen delivered in the UK FAST-Forward Trial. Radiother Oncol. 2016 Jul;120(1):114-8. doi: 10.1016/j.radonc.2016.02.027. Epub 2016 Apr 1.

  PMID: 27046390 RESULT

• • Fast forward protocol, Version 3.0: 08/07/2015: https://njl-admin.nihr.ac.uk/document/download/2006786.

  RESULT

• FAST Trialists group; Agrawal RK, Alhasso A, Barrett-Lee PJ, Bliss JM, Bliss P, Bloomfield D, Bowen J, Brunt AM, Donovan E, Emson M, Goodman A, Harnett A, Haviland JS, Kaggwa R, Morden JP, Robinson A, Simmons S, Stewart A, Sydenham MA, Syndikus I, Tremlett J, Tsang Y, Wheatley D, Venables K, Yarnold JR. First results of the randomised UK FAST Trial of radiotherapy hypofractionation for treatment of early breast cancer (CRUKE/04/015). Radiother Oncol. 2011 Jul;100(1):93-100. doi: 10.1016/j.radonc.2011.06.026.

  PMID: 21752481 RESULT

• Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.

  PMID: 24055415 RESULT

• Dragun AE, Ajkay NJ, Riley EC, Roberts TL, Pan J, Rai SN, Jain D, Quillo AR, Scoggins CR, McMasters KM, Woo SY. First Results of a Phase 2 Trial of Once-Weekly Hypofractionated Breast Irradiation (WHBI) for Early-Stage Breast Cancer. Int J Radiat Oncol Biol Phys. 2017 Jul 1;98(3):595-602. doi: 10.1016/j.ijrobp.2017.01.212.

  PMID: 28581400 RESULT

Study Officials

• Marwa M El Awadly

  National Cancer Institute, Cairo University, Egypt

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 18, 2019
• First Posted: November 1, 2019
• Study Start: November 1, 2017
• Primary Completion: March 1, 2020
• Study Completion: March 1, 2020
• Last Updated: September 16, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: January 2021
• Access Criteria: marwa.awadly@nci.cu.edu.eg

Locations

EG (1)