Prospective Comparative Study of Hypofractionated Adjuvant Radiotherapy in 2 Virsus 3 Weeks in Breast Cancer

NCT07344597 | Not Yet Recruiting

• 1 other identifier: adjuvant radiotherapy in BC
• Study Type: observational
• Target: 70
• Locations: 1 country
• Sites: 1

Brief Summary

To compare the efficacy and safety of two hypofractionated adjuvant radiotherapy regimens 34 Gy in 10 fractions versus 40.05 Gy in 15 fractions in patients with breast cancer treated at the South Egypt Cancer Institute.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Disease free survival analyzed from the date of diagnosis.

  local control was defined as absence of disease in the irradiated areas.recurrence were categorized as local(breast or surgical bed), regional(lymphatic drainage of axillary, supraclavicular fossa or internal mammary chain),or distant (metastasis),and any associayion of these

  through study completion, an average of 1 year

Secondary Outcomes (2)

• Assessment of Acute Skin Toxicity

  From start of radiotherapy through 3 months after completion of radiotherapy

• Assessment of Late Skin Toxicity

  From 3 months after completion of radiotherapy through study completion, an average of 1 year

Study Arms (2)

A

hypofractionated adjuvant radiotherapy regimens 40.05 Gy in 15 fractions in breast cancer in 3w

Device: radiotherapy

B

hypofractionated adjuvant radiotherapy regimens 34 Gy in 10 fractions in 2w

Device: radiotherapy

Interventions

radiotherapy DEVICE

Hypofractionated Adjuvant Radiotherapy in 2 versus 3 Weeks of Breast Cancer and effect skin toxicity and over all survival

A; B

Eligibility Criteria

• Age: 18 Years - 100 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

breast cancer patients above 18y,with invasive carcinoma,excision of primary,recieved neoadjuvant or adj cth .

You may qualify if:

• Female patients aged ≥18 years.
• Female or male patients with invasive carcinoma of the breast.
• Complete microscopic excision of primary tumor.
• Undergoing breast-conserving surgery (BCS) or modified radical mastectomy (MRM).
• ≥ Axillary lymph nodes dissected.
• T1\_4pN0\_3M0 disease.
• Neoadjuvant or adjuvant CTH .
• Signed informed consent and able to comply with follow up.

You may not qualify if:

• Evidence of distant metastases.
• Past history of malignancy.
• Prior radiotherapy to the chest region
• Simultaneous malignancy (except non-melanoma skin cancer or in situ cervical carcinoma)
• Connective tissue diseases (e.g., lupus erythematosus, scleroderma)
• Pregnancy or lactation

Sponsors & Collaborators

• Salwa Shawky Bakeet Ali: lead

Study Sites (1)

Assuit

Asyut, Egypt

Location

Related Publications (6)

• Youssef A, Stanford J. Hypofractionation Radiotherapy vs. Conventional Fractionation for Breast Cancer: A Comparative Review of Toxicity. Cureus. 2018 Oct 29;10(10):e3516. doi: 10.7759/cureus.3516.

  PMID: 30648051 RESULT

• Eraso A, Sanz J, Molla M, Reyes V, Pedro A, Arenas M, Martinez E, Ballester R, Cambra MJ, Garcia V, Prades JL, Borras JM, Algara M. Evidence-based guidelines for hypofractionated radiation in breast cancer: conclusions of the Catalan expert working group. Clin Transl Oncol. 2022 Aug;24(8):1580-1587. doi: 10.1007/s12094-022-02798-8. Epub 2022 Feb 21.

  PMID: 35190961 RESULT

• Kim N, Kim YB. Journey to hypofractionation in radiotherapy for breast cancer: critical reviews for recent updates. Radiat Oncol J. 2022 Dec;40(4):216-224. doi: 10.3857/roj.2022.00577. Epub 2022 Dec 26.

  PMID: 36606299 RESULT

• Yadav BS, Dahiya D, Gupta A, Rana D, Robert N, Sharma M, Rao B. Breast cancer hypofractionated radiotherapy in 2-weeks with 2D technique: 5-year clinical outcomes of a phase 2 trial. Rep Pract Oncol Radiother. 2021 Aug 12;26(4):503-511. doi: 10.5603/RPOR.a2021.0054. eCollection 2021.

  PMID: 34434565 RESULT

• START Trialists' Group; Bentzen SM, Agrawal RK, Aird EG, Barrett JM, Barrett-Lee PJ, Bliss JM, Brown J, Dewar JA, Dobbs HJ, Haviland JS, Hoskin PJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Morgan DA, Owen JR, Simmons S, Sumo G, Sydenham MA, Venables K, Yarnold JR. The UK Standardisation of Breast Radiotherapy (START) Trial A of radiotherapy hypofractionation for treatment of early breast cancer: a randomised trial. Lancet Oncol. 2008 Apr;9(4):331-41. doi: 10.1016/S1470-2045(08)70077-9. Epub 2008 Mar 19.

  PMID: 18356109 RESULT

• Zhang Y, Ji Y, Liu S, Li J, Wu J, Jin Q, Liu X, Duan H, Feng Z, Liu Y, Zhang Y, Lyu Z, Song F, Song F, Yang L, Liu H, Huang Y. Global burden of female breast cancer: new estimates in 2022, temporal trend and future projections up to 2050 based on the latest release from GLOBOCAN. J Natl Cancer Cent. 2025 Feb 13;5(3):287-296. doi: 10.1016/j.jncc.2025.02.002. eCollection 2025 Jun.

  PMID: 40693239 RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Radiotherapy

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Therapeutics

Central Study Contacts

SALWA SHAWKY BAKEET

CONTACT

+2001154224860; mybestuserfriend@gmail.com

samir shehata mohamed, professor

CONTACT

01222302375; Samir_eid@hotmai.com

Study Design

• Study Type: observational
• Observational Model: OTHER
• Time Perspective: PROSPECTIVE
• Target Duration: 3 Months
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assiut

Study Record Dates

• First Submitted: September 25, 2025
• First Posted: January 15, 2026
• Study Start: January 1, 2026
• Primary Completion (Estimated): January 1, 2027
• Study Completion (Estimated): February 1, 2027
• Last Updated: January 15, 2026

Record last verified: 2026-01

Locations

EG (1)