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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| proton plus carbon ion radiotherapy | Experimental | CTV1: whole breast, proton therapy. CTVboost: Tumor bed, carbon ion dose escalation study with four dose levels. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| proton plus carbon ion radiotherapy | 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 ]. |
| Measure | Description | Time Frame |
|---|---|---|
| Acute toxicity | Treatment related acute toxicity assessed by CTCAE v4.03 | 3 months after the completion of CIRT |
| Measure | Description | Time Frame |
|---|---|---|
| Local regional recurrence | The Ipsilateral breast and regional lymph nodes recurrence | within 5 years after radiotherapy. |
| Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale |
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Inclusion Criteria:
Exclusion Criteria:
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shanghai Proton and Heavy Ion center | Recruiting | Shanghai | China |
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Cosmetic outcome will be evaluated by Breast Cancer Treatment Outcomes Scale filled out by patients.
| within 5 years after radiotherapy. |
| 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. |
| ID | Term |
|---|---|
| D064726 | Triple Negative Breast Neoplasms |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D011522 | Protons |
| D063193 | Heavy Ion Radiotherapy |
| ID | Term |
|---|---|
| D002414 | Cations, Monovalent |
| D002412 | Cations |
| D007477 | Ions |
| D004573 | Electrolytes |
| D007287 | Inorganic Chemicals |
| D006859 | Hydrogen |
| D004602 | Elements |
| D005740 | Gases |
| D000071940 | Nucleons |
| D004601 | Elementary Particles |
| D055585 | Physical Phenomena |
| D011878 | Radiotherapy |
| D013812 | Therapeutics |
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