Super-Hypofractionated Partial Breast Irradiation

Super-Hypofractionated Partial Breast Irradiation After Breast-Conserving Surgery for Early-Stage Low-Risk Breast Cancer: a Prospective, Single-arm Trial

Partial breast irradiation is currently a hot topic in clinical research, but the appropriate population and appropriate irradiation The technology and dose fractionation mode are still inconclusive. Foreign studies have mostly selected patients with low risk of recurrence. Breast-conserving surgeries for early-stage breast cancer are increasing year by year in China. It is necessary to conduct prospective clinical studies to explore the Chinese population suitable for partial breast irradiation and the appropriate radiotherapy dose fractionation model. A preliminary study in our center has compared the safety and efficacy of a 2-week schedule of partial breast irradiation (40Gy/10f) and a 3-week schedule of whole-breast radiotherapy (43.5Gy/15f) in patients with early-stage low-risk breast cancer after breast-conserving surgery. , preliminary results show that the 2-week partial breast irradiation regimen is safe and effective. This study plans to continue to select low-risk breast-conserving patients, use extracorporeal intensity-modulated radiotherapy technology, refer to the radiotherapy dose fractionation model of the FAST-Forward study, and give partial breast irradiation 5.2 Gy/f/d, a total of 5 times, with a total dose of 26Gy, to further shorten the time The radiotherapy time is 1 week, and the acute and late adverse reactions of radiotherapy and the local control of the tumor are prospectively observed. Provide evidence for conducting a national multi-center phase III clinical randomized study.

Study Overview

• Status: Recruiting
• Conditions: Breast Cancer; Radiotherapy Side Effect
• Intervention / Treatment: Radiation: Partial Breast Irradiation

• Study Type: Interventional
• Enrollment (Estimated): 50
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Guangyi Sun; Phone Number: 086-18811100731; Email: sungy@cicams.ac.cn

Study Locations

• China
  • Beijing
    • Beijing, Beijing, China, 100021
      • Recruiting
      • Cancer Hospital ,National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College
      • Contact: Guangyi Sun; Phone Number: 086-18811100731; Email: sungy@cicams.ac.cn
      • Contact: Shulian Wang, MD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

Inclusion Criteria:

1. ≥45 years old, <75 years old women
2. Life expectancy >5 years
3. Start radiotherapy within 12 weeks after breast-conserving surgery (or within 8 weeks from the end of chemotherapy)

4. Invasive ductal carcinoma grade 1-2, or mucinous carcinoma, papillary carcinoma, canalicular carcinoma, medullary carcinoma; primary tumor

   ≤3.0cm; both pN0 (axillary dissection or sentinel lymph node biopsy)

5. Low-risk DCIS: tumor ≤2.5cm, low to medium grade; axillary surgery is not required or pN0
6. Single focus (with MRI diagnosis)
7. Vascular tumor thrombus negative
8. ER and/or PR positivity (defined as strong positivity in >1% of tumor cell nuclei)
9. Negative pathological margin≥2mm
10. Place metal markers on the tumor bed
11. Sign the informed consent form

Exclusion Criteria:

1. Multiple primary tumors
2. Invasive ductal carcinoma grade 3
3. Invasive micropapillary carcinoma
4. Lobular carcinoma in situ
5. Invasive lobular carcinoma
6. Simple nipple paget's disease
7. Oncoplastic surgery
8. Neoadjuvant chemotherapy or neoadjuvant endocrine therapy
9. Previous or simultaneous contralateral breast cancer
10. History of ipsilateral chest wall radiotherapy
11. Have active collagen vascular disease

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: Partial Breast Irradiation	Radiation: Partial Breast Irradiation; 26Gy/5.2Gy/5f

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Incidence of acute adverse reactions	up to 6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Incidence of late adverse reactions		through study completion, an average of 5 year
Survival	Local recurrence rate, regional recurrence rate, distant metastasis rate, disease-free survival rate and overall survival rate	through study completion, an average of 5 year

Collaborators and Investigators

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

Study record dates

Study Major Dates

• Study Start (Actual): April 22, 2022
• Primary Completion (Estimated): December 1, 2024
• Study Completion (Estimated): September 1, 2027

Study Registration Dates

• First Submitted: April 18, 2024
• First Submitted That Met QC Criteria: September 24, 2024
• First Posted (Actual): September 26, 2024

Study Record Updates

• Last Update Posted (Actual): September 26, 2024
• Last Update Submitted That Met QC Criteria: September 24, 2024
• Last Verified: April 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Skin Diseases; Neoplasms; Neoplasms by Site; Breast Diseases; Breast Neoplasms
• Other Study ID Numbers: NCC-008224; 22/117-3318

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
• product manufactured in and exported from the U.S.: No