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

NCT ID: NCT05692661

Last Updated: 2023-01-20

Basic Information

• Recruitment Status: RECRUITING
• Clinical Phase: PHASE1
• Total Enrollment: 24 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2023-01-10
• Study Completion Date: 2026-01-10

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.

Conditions

Triple Negative Breast Cancer; HER2-positive Breast Cancer

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

proton plus carbon ion radiotherapy

CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels.

Group Type: EXPERIMENTAL

proton plus carbon ion radiotherapy

Intervention Type: RADIATION

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 \[10.2Gy(RBE)/3Fx,10.8Gy(RBE) /3Fx,11.4Gy(RBE)/3Fx and 12Gy(RBE)/3Fx \].

Interventions

proton plus carbon ion radiotherapy

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 \[10.2Gy(RBE)/3Fx,10.8Gy(RBE) /3Fx,11.4Gy(RBE)/3Fx and 12Gy(RBE)/3Fx \].

Intervention Type: RADIATION

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Shanghai Proton and Heavy Ion Center

OTHER

Sponsor Role: lead

Responsible Party

Qing Zhang,MD

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Shanghai Proton and Heavy Ion center

Shanghai, , China

Site Status: RECRUITING

Countries

China

Facility Contacts

Ping Li

Role: primary

ping.li@sphic.org.cn

+86 021-38296666

Other Identifiers

SPHIC-TR-BCa2022-01

Identifier Type: -

Identifier Source: org_study_id