HER2-positive Breast Cancer, Triple Negative Breast Cancer
Conditions
Keywords
Breast Cancer, HER2 Positive, Triple Negative, Proton and Carbon Ion, Dose Escalation
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.
Interventions
RADIATIONproton 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 \[10.2Gy(RBE)/3Fx,10.8Gy(RBE) /3Fx,11.4Gy(RBE)/3Fx and 12Gy(RBE)/3Fx \].
Sponsors
Shanghai Proton and Heavy Ion Center
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to 80 Years
Healthy volunteers
No
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Acute toxicity | 3 months after the completion of CIRT | Treatment related acute toxicity assessed by CTCAE v4.03 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Local regional recurrence | within 5 years after radiotherapy. | The Ipsilateral breast and regional lymph nodes recurrence |
| Cosmetic outcome as measured by Breast Cancer Treatment Outcomes Scale | within 5 years after radiotherapy. | Cosmetic outcome will be evaluated by Breast Cancer Treatment Outcomes Scale filled out by patients. |
| Cosmetic outcome as measured by BCCT.core software | within 5 years after radiotherapy. | 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. |
Countries
China
Outcome results
None listed