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

Shanghai Proton and Heavy Ion Center

Status and phase

Enrolling

Phase 1

Conditions

HER2-positive Breast Cancer

Triple Negative Breast Cancer

Treatments

Radiation: proton plus carbon ion radiotherapy

Study type

Interventional

Funder types

Other

Identifiers

NCT05692661

SPHIC-TR-BCa2022-01

Details and patient eligibility

About

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.

Enrollment

24 estimated patients

Sex

Female

Ages

18 to 80 years old

Volunteers

No Healthy Volunteers

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