Hypofractionated Radiation Therapy vs Standard Treatment in Breast Cancer.

Invasive Breast Cancer Clinical Trial

Official title:

Hypofractionated Radiation Therapy (1 Week) Compared With Standard Treatment (3.1 Weeks), Evaluation of Local Control of Breast Cancer Treated With Conservative Surgery.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05318274
• Other study ID #: R-2021-3203-005
• Status: Recruiting
• Phase: N/A
• Start date: April 26, 2021
• Est. completion date: June 30, 2026

Study information

• Verified date: November 2022
• Source: Coordinación de Investigación en Salud, Mexico
• Contact: Patricia B Bolado-García, MD.
• Phone: 9994695696
• Email: investigacion.umae.imss[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

An explanatory study comparing complementary treatment to breast conservative surgery with radiation therapy DCIS, T1-T2 N0 M0 (AJCC v8) 1 week schedule vs 3.1 weeks standard schedule, in order to determine the equivalence of local tumor control, survival, acute and chronic toxicity. Shorter curse of radiation therapy may lead to similar local control of tumor cells and lower rates of toxicity than 3.1 standard treatment.

Description:

PRIMARY OBJECTIVE: I. Compare the effectiveness of hypofractionated radiotherapy (1 week) with standard treatment (3.1 weeks) in the local control of breast cancer treated with conservative surgery. SECONDARY OBJECTIVES: I. Identify the histological lineage of the tumor. II. Identify the degree of differentiation of tumor cells. III. Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry. IV. Measure the frequency of progression or recurrence. V. Identify the site of progression or recurrence. VI. Measure the frequency of toxicity in both groups. VII. Classify toxicity according to its severity. VIII. Classify toxicity according to chronological presentation, acute, subacute, or chronic. IX. Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale, Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23). X. Measure quality of life in both groups according to the Eastern Collaborative Oncology Group (ECOG) performance scale. XI. Measure 5-year survival. OUTLINE: Patients are randomized to 1 of 2 arms. ARM I: will receive radiotherapy treatment with high hypofractionation, 26 Gy in 5 fractions to the whole breast. ARM II: will receive radiotherapy treatment with standard hypofractionation, 42.5 Gy in 16 fractions with simultaneous integrated increase of 5.5 Gy to the tumor bed in high-risk patients. After completion of treatments, patients will be followed: 2 weeks after final fraction, 6 weeks after final fraction, every 4 months for the next 5 years

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 72
• Est. completion date: June 30, 2026
• Est. primary completion date: March 30, 2026
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients diagnosed by histopathological report of ductal carcinoma in situ (DCIS) or invasive breast carcinoma.
• Treated with breast-conserving surgery and stage pT1-2 pN0 M0.
• Over 18 years.
• Patients who sign informed consent for research study.

Exclusion Criteria:

• Positive nodes.
• Clinical or pathological stage T3-T4.
• History of previous irradiation.
• Postoperative positive margin.

Related Conditions & MeSH terms

• Breast Carcinoma In Situ
• Breast Neoplasms
• Carcinoma in Situ
• Carcinoma, Ductal, Breast
• Carcinoma, Intraductal, Noninfiltrating
• Ductal Breast Carcinoma in Situ
• Early-stage Breast Cancer
• Invasive Breast Cancer
• Stage 0 Breast Cancer
• Stage I Breast Cancer
• Stage IA Breast Cancer
• Stage IB Breast Cancer

Intervention

Radiation:
• Hypofractionated radiotherapy
Ultra hypofractionated 26 Gy in 5 fractions applied once with daily port film.

Locations

Country	Name	City	State
Mexico	Unidad Medica de Alta Especialidad	Mérida	Yucatán

Sponsors (1)

Lead Sponsor	Collaborator
Coordinación de Investigación en Salud, Mexico

Country where clinical trial is conducted

Mexico, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Breast Cancer-Specific Quality of Life Questionnaire, (EORTC, QLQ-BR23).	Quantify quality of life with QLQ-BR23 questionnaire created by the European Organization for Research and Treatment of Cancer Group	5 Years
Other	Measure quality of life in both groups according to the European Organization for Research and Treatment Cancer scale (ECOG)	Quantify quality of life with Eastern Cooperative Oncology Group (ECOG) Performance Status Scale	5 Years
Primary	Identify the progression timing.	Quantify the time to progression through follow up in both groups	5 years
Primary	Identify the recurrence timing.	Quantify the time to recurrence through follow up in both groups	5 years
Secondary	Identify the histological lineage of the tumor	Carcinoma InSitu or Invasive Carcinoma; - Adenocarcinoma; - Other	14 Months
Secondary	Identify the degree of differentiation of tumor cells	Histologic grade identification using Scarff-Bloom-Richardson (SBR) scale; Grade 1: 3-5 points; Grade 2: 6-7 points; Grade 3: 8-9 points	14 months
Secondary	Identify the presence and type of receptors (estrogen, progesterone, HER-2NEU) through immunohistochemistry	Number of participants with presence of Luminal A, B, HER-2NEU enriched or triple negative immunohistochemistry subtype.; Luminal A: RE (+), RP >20%, Ki67 <20% y HER 2 NEU (-); Luminal B: RE (+), RP <20%, Ki67 >20% y HER 2 NEU (+/-); HER-2 Enriched: RE (-), RP (-),Ki67 any, HER 2 NEU (+); Triple Negative: RE (-), RP (-), Ki67 any, HER-2 (-)	14 months
Secondary	Measure the frequency of toxicity in both groups.	Quantify the presence of toxicity categorized by CTCAE version 5 system.; Grade 1: characterized by the presence of a mild adverse event that does not require treatment; Grade 2: considers a moderate adverse event that may require medical treatment on an outpatient basis; Grade 3: is a serious adverse event that should receive medical treatment, and even hospital treatment.; Grade 4: is an adverse event with risk of death or disability that requires specialized medical management and hospitalization.; Grade 5: considers the presence of death associated with an adverse event.	5 years
Secondary	Classify toxicity according to its severity.	Quantify toxicity according to its severity categorized by CTCAE version 5 system.; Dry skin: A disorder characterized by flaky and dull skin; the pores are generally fine, the texture is a papery thin texture; - Grade 1 to 3; Eczema: A disorder characterized by skin which becomes itchy, red, inflamed, crusty, thick, scaly, and/or forms blisters.; - Grade 1 to 3; Skin hyperpigmentation: A disorder characterized by darkening of the skin due to excessive melanin deposition.; - Grade 1 to 2; Dysphagia: A disorder characterized by difficulty in swallowing.; - Grade 1 to 4; Cough: A disorder characterized by sudden, often repetitive, spasmodic contraction of the thoracic cavity, resulting in violent release of air from the lungs and usually accompanied by a distinctive sound.; - Grade 1 to 3; Pneumonitis: A disorder characterized by inflammation focally or diffusely affecting the lung parenchyma.; Grade 1 to 5	5 years