Ultra-hypofractioNated Adjuvant Radiotherapy ± sImultaneous Integrated Boost for Low-risk Breast Cancer Patients (UNIQUE)

Ultra-hypofractioNated Radiotherapy ± sImultaneous Integrated Boost for Low-risk(risQue) Breast Cancer Patients After Breast Conservative sUrgery or mastEctomy (UNIQUE)

This is a phase II study to investigate the feasibility of Ultra-hypofractionated radiotherapy with or without simultaneous integrated boost for low risk breast cancer patients who have received breast conservative surgery of mastectomy.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiotherapy Side Effect
• Intervention / Treatment: Radiation: Ultra-fractionated radiation therapy

Detailed Description

During the study, the patients would undergo radiation of 5.2Gy for 5 fractions to the prophylactic radiation volumes and and a 6Gy per-fraction simultaneous boost to the tumor bed or other high-risk volumes. Acute toxicity of grade 2 or higher in the following 12 weeks after radiotherapy is the primary end point.

• Study Type: Interventional
• Enrollment (Anticipated): 65
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: Shu-Lian Wang, M.D.; Phone Number: 8610-87788290; Email: wangsl@cicams.ac.cn

Study Locations

• China
  • Beijing, China, 100021
    • Recruiting
    • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
    • Contact: Hao Jing, M.D.; Phone Number: 8610-87788281; Email: owletskim@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 35 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

Description

Inclusion Criteria:

1. Patients diagnosed with invasive or non-invasive breast cancer;
2. The patients have undergone breast-conserving surgery or mastectomy with axillary sentinel nodal biopsy or dissection;
3. Stage ypT0-2N0-1 (if receive neoadjuvant therapy) or stage pT0-2N0-1 (if receive upfront surgery).
4. No distant metastasis;
5. Life expectancy ≥6 months;
6. Organ function is fine (Hemoglobin ≥100g/L, leukocyte ≥2×109/L, neutrophil ≥1×109/L, platelet ≥80×109/L; Creatinine 1.5 mg/dl or less; Alanine aminotransferase/aspartate aminotransferase ≤2.5×UNL.);
7. Patients are willing to cooperate to follow up;
8. Patients should sign the informed consent;
9. Women of childbearing age need effective contraception.

Exclusion Criteria:

1. Biopsy proven ipsilateral supraclavicular, infraclavicular or internal mammary nodal involvement.
2. Concurrent or previous neuropathy overlapping with the radiation volume or brachial plexus injury;
3. Patients who had radiotherapy to the ipsilateral breast, lymph-drainage regions or adjacent areas before;
4. Concurrent active connective tissue disease;
5. Other malignancies, which affect patient life expectancy (except adequately treated basal cell carcinoma of the skin, carcinoma in situ of the cervix, superficial bladder neoplasms (no more than T1), early stage thyroid carcinoma);
6. Severe comorbidities or active disease (Poorly controlled heart disease: New York Classification of Cardiac Function ≥ Grade 2, active coronary heart disease, unstable angina pectoris, arrhythmia requiring medical treatment/persistent refractory hypertension; Myocardial infarction, stroke within six months; Poorly controlled diabetes persists. Fasting blood glucose ≥ 10mmol/L, 2 hours postprandial blood glucose ≥ 13 mmol/L. Poorly controlled psychosis develops or worsens within six months; Active infection; Positive for antibodies to HIV).
7. Pregnant or breast-feeding.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Ultra-hypofractionated arm; The patients will be treated by Ultra-hypofractionated irradiation.	Radiation: Ultra-fractionated radiation therapy; 5.2Gy per fraction for 5 fractions with an integrated boost of 6Gy per fraction.; Other Names: Simultaneous Integrated Boost

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
The rate of patients who develop radiation-associated acute toxicity (≥ 2 degree)	The investigators will record the incidence of ≥ 2 degree radiation-associated acute toxicity, such as breast or chest wall oedema, acute dermatitis, breast pain,itch of breast skin; ≥ 3 degree radiation-associated esophagitis; ≥ 3 degree radiation-associated lymphopenia.	until 12 weeks from the completion of postoperative radiotherapy

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Local recurrence rate	The incidence of recurrence of any invasive or non-invasive breast cancer in the ipsilateral breast or chest wall.	Local recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Local regional recurrence rate	The incidence of recurrence in the ipsilateral breast/chest wall or the lymphatic nodal regions.	Local regional recurrence rate would be recorded and reported until at least 5 years after diagnosis.
Disease-free survival	The time interval from diagnosis to any event of recurrence or death.	Until at least 5 years after diagnosis.
Overall survival	The time interval from diagnosis to death from any reason.	Until at least 5 years after diagnosis.
The rate of patients who develop radiation-associated long-term toxicity	The investigators will record the incidence of any long-term toxicities, such as skin or subcutaneous fibrosis, pain, breast distortion, brachial plexopathy, lymphodema, cardiac event, rib fracture, pulmonary fibrosis, and so on.	From 12 weeks to 5 years post radiotherapy.
Quality of Life.	European Organization for Research and Treatment of Cancer General Quality of Life Questionnaire (brev: EORTC C-30) is used. The higher the score, the worse the situation, with the range of 28 to 112.	European Organization Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire EORTC QLQ-C30 to record patients' quality of life before and at 12, 24 and 60 months after radiotherapy.
Quality of Life.	European Organization for Research and Treatment of Cancer Breast Cancer-Specific Quality of Life Questionnaire (brev: EORTC BR-23) is used. The higher the score, the worse the situation, with the range of 23 to 92.	The patients' quality of life will be evaluated before and at 12, 24 and 60 months after radiotherapy.
The cosmetic outcome.	Breast Cancer Treatment Outcome Scale 22 (brev: BCTOS 22) is used, for patients who receive breast conservative surgery. The higher the score, the worse the cosmesis, with the range of 22 to 88.	The cosmetic outcome will be evaluated before and at 12, 24 and 60 months after radiotherapy.

Collaborators and Investigators

• Sponsor: Cancer Institute and Hospital, Chinese Academy of Medical Sciences

Study record dates

Study Major Dates

• Study Start (Actual): October 25, 2022
• Primary Completion (Anticipated): October 25, 2025
• Study Completion (Anticipated): October 25, 2030

Study Registration Dates

• First Submitted: February 20, 2023
• First Submitted That Met QC Criteria: March 9, 2023
• First Posted (Estimate): March 10, 2023

Study Record Updates

• Last Update Posted (Estimate): March 10, 2023
• Last Update Submitted That Met QC Criteria: March 9, 2023
• Last Verified: March 1, 2023

More Information

Terms related to this study

• Keywords: Breast cancer; Toxicity; Ultra-fractionated radiotherapy; Lymph-drainage region irradiation
• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: 22/409-3611

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No