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

Status: Recruiting
Location: See location...
Intervention Type: Radiation
Study Type: Interventional
Study Phase: Phase 1
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.

Eligibility
Participation Requirements
Sex: Female
Minimum Age: 18
Maximum Age: 80
Healthy Volunteers: f
View:

• 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.

Locations
Other Locations
China
Shanghai Proton and Heavy Ion center
RECRUITING
Shanghai
Time Frame
Start Date: 2023-01-10
Estimated Completion Date: 2026-01-10
Participants
Target number of participants: 24
Treatments
Experimental: proton plus carbon ion radiotherapy
CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels.
Sponsors
Leads: Shanghai Proton and Heavy Ion Center

This content was sourced from clinicaltrials.gov