A Dose Escalation Study of Proton and Carbon Ion Irradiation for HER2 Positive and Triple Negative Breast Cancer After Breast Conserving Surgery
Overview
- Phase
- Phase 1
- Intervention
- Not specified
- Conditions
- Triple Negative Breast Cancer
- Sponsor
- Shanghai Proton and Heavy Ion Center
- Enrollment
- 24
- Locations
- 1
- Primary Endpoint
- Acute toxicity
- Status
- Recruiting
- Last Updated
- 3 years ago
Overview
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.
Investigators
Qing Zhang,MD
Professor
Shanghai Proton and Heavy Ion Center
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.
Outcomes
Primary Outcomes
Acute toxicity
Time Frame: 3 months after the completion of CIRT
Treatment related acute toxicity assessed by CTCAE v4.03
Secondary Outcomes
- Local regional recurrence(within 5 years after radiotherapy.)
- Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale(within 5 years after radiotherapy.)
- Cosmetic outcome as measured by BCCT.core software(within 5 years after radiotherapy.)