A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer

Phase 1

Recruiting

• Conditions: Triple Negative Breast Cancer; HER2-positive Breast Cancer
• Interventions: Radiation: proton plus carbon ion radiotherapy

• Registration Number: NCT05692661
• Lead Sponsor: Shanghai Proton and Heavy Ion Center

Brief Summary

Adjuvant radiotherapy is the standard treatment for early breast cancer after breast conserving surgery. Molecular subtypes was significantly associated with the risk of local recurrence of breast cancer. Nguyen et al found that the overall 5-year cumulative incidence of local recurrence was 0.8% for luminal A, 1.5% for luminal B, 8.4% for HER2 positive, and 7.1% for triple negative breast cancer after lumpectomy and radiotherapy. Her2 positive and triple negative breast cancers may be inherently radioresistant.

Therefore, for HER2 positive and triple negative breast cancer with high local recurrence and radiation resistance, proton combined with carbon ion is proposed after breast conserving surgery.

Detailed Description

Not available

Study Timeline

• Status Verified: 2023-01
• Study Start: 2023-01-10
• Study First Submitted: 2023-01-11
• Study First Submitted QC: 2023-01-11
• Last Update Submitted: 2023-01-11
• Study First Posted: 2023-01-20
• Last Update Posted: 2023-01-20
• Primary Completion: 2025-10-10
• Study Completion: 2026-01-10

Recruitment & Eligibility

• Status: RECRUITING
• Sex: Female
• Target Recruitment: 24

Inclusion Criteria

• Histologically confirmed HER2 positive or Triple Negative invasive breast carcinoma.(HER2 positive: immunohistochemistry [IHC] 3+ and or fluorescence in situ hybridization [FISH] amplified; Triple Negative: estrogen receptor [ER] and progesterone receptor [PR] < 1%, HER2 negative [IHC 1+ or 2+ FISH non-amplified])
• Age ≥ 18 years and ≤ 80 years.
• The primary tumor must be excised via breast conserving surgery.
• Stage p T1-2 N0 M0
• ECOG performance status ≤2.

Exclusion Criteria

• Invasive breast cancer not confirmed by pathology.
• Distant metastasis
• Prior thoracic radiation.
• Pregnancy or lactating.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
proton plus carbon ion radiotherapy	proton plus carbon ion radiotherapy	CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels.

Primary Outcome Measures

Name	Time	Method
Acute toxicity	3 months after the completion of CIRT	Treatment related acute toxicity assessed by CTCAE v4.03

Secondary Outcome Measures

Name	Time	Method
Local regional recurrence	within 5 years after radiotherapy.	The Ipsilateral breast and regional lymph nodes recurrence
Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale	within 5 years after radiotherapy.	Cosmetic outcome will be evaluated by Breast Cancer Treatment Outcomes Scale filled out by patients.
Cosmetic outcome as measured by BCCT.core software	within 5 years after radiotherapy.	Patients' photographs of the breasts will be taken. With the use of BCCT.core software from The Breast Research group (INESC TEC) cosmetic outcome will be assessed.

Trial Locations

Locations (1)

Shanghai Proton and Heavy Ion center; 🇨🇳 Shanghai, China