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

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

NCT ID: NCT05692661

Condition: Triple Negative Breast Cancer
HER2-positive Breast Cancer

Conditions: Official terms:
Breast Neoplasms
Triple Negative Breast Neoplasms

Conditions: Keywords:
Breast Cancer
HER2 Positive
Triple Negative
Proton and Carbon Ion
Dose Escalation

Study type: Interventional

Study phase: Phase 1

Overall status: Recruiting

Study design:

Allocation: N/A

Intervention model: Single Group Assignment

Primary purpose: Treatment

Masking: None (Open Label)

Intervention:

Intervention type: Radiation
Intervention name: proton plus carbon ion radiotherapy
Description: CTV1: whole breast, 40.05Gy(RBE) in 15 fractions with proton ion therapy; CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels [10.2Gy(RBE)/3Fx,10.8Gy(RBE) /3Fx,11.4Gy(RBE)/3Fx and 12Gy(RBE)/3Fx ].
Arm group label: proton plus carbon ion radiotherapy

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.

Criteria for eligibility:
Criteria:
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.

Gender: Female

Minimum age: 18 Years

Maximum age: 80 Years

Healthy volunteers: No

Locations:

Facility:
Name: Shanghai Proton and Heavy Ion center

Address:
City: Shanghai
Country: China

Status: Recruiting

Contact:
Last name: Ping Li

Phone: +86 021-38296666
Email: ping.li@sphic.org.cn

Start date: January 10, 2023

Completion date: January 10, 2026

Lead sponsor:
Agency: Shanghai Proton and Heavy Ion Center
Agency class: Other

Source: Shanghai Proton and Heavy Ion Center

Record processing date: ClinicalTrials.gov processed this data on November 12, 2024

Source: ClinicalTrials.gov page: https://clinicaltrials.gov/ct2/show/NCT05692661