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

Triple Negative Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05692661
• Other study ID #: SPHIC-TR-BCa2022-01
• Status: Recruiting
• Phase: Phase 1
• Start date: January 10, 2023
• Est. completion date: January 10, 2026

Study information

• Verified date: January 2023
• Source: Shanghai Proton and Heavy Ion Center
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 24
• Est. completion date: January 10, 2026
• Est. primary completion date: October 10, 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms
• HER2-positive Breast Cancer
• Triple Negative Breast Cancer
• Triple Negative Breast Neoplasms

Intervention

Radiation:
• 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 ].

Locations

Country	Name	City	State
China	Shanghai Proton and Heavy Ion center	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
Shanghai Proton and Heavy Ion Center

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Acute toxicity	Treatment related acute toxicity assessed by CTCAE v4.03	3 months after the completion of CIRT
Secondary	Local regional recurrence	The Ipsilateral breast and regional lymph nodes recurrence	within 5 years after radiotherapy.
Secondary	Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale	Cosmetic outcome will be evaluated by Breast Cancer Treatment Outcomes Scale filled out by patients.	within 5 years after radiotherapy.
Secondary	Cosmetic outcome as measured by BCCT.core software	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.	within 5 years after radiotherapy.