Early-Stage Breast Cancer
Conditions
Keywords
Proton, Radiation, Breast cancer
Brief summary
The purpose of this study is to determine if partial breast proton therapy is effective treatment for early stage breast cancer following lumpectomy.
Detailed description
Radiation therapy is considered standard treatment for most women with early stage breast cancer following lumpectomy. Post-lumpectomy radiotherapy is a proven treatment that reduces cancer recurrence in the breast and improves survival. When standard whole breast radiation techniques are utilized, portions of the chest wall, lung and heart may also receive significant doses of radiation which can lead to radiation induced complications. Radiation techniques that limit the treatment area to the portion of the breast where the cancer arose can minimize and even eliminate radiation dose to the chest wall, heart and lung. This is called partial breast radiotherapy. This study is designed to evaluate the use of proton beam radiotherapy to deliver partial breast radiotherapy in women with early stage breast cancer.
Interventions
RADIATIONProton radiation therapy
Proton radiotherapy will start 2-4 weeks following surgical excision. The treatment area will include the lumpectomy site with an additional margin. Daily proton therapy will be given as an out-patient over a two week coarse.
Sponsors
Loma Linda University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Invasive ductal, medullary, papillary, colloid or tubular histologies * Stages T1 or T2 (tumors \< or = 3 cm) from lumpectomy specimen. * No more then 3 positive nodes on axillary dissection or negative sentinel node. * Negative surgical margins (\>2mm)
Exclusion criteria
* Invasive lobular histology * Previous chemotherapy for breast cancer * Extensive intraductal component * Collagen vascular disease * Prior malignancy unless disease-free for 5 years * Patients who are pregnant or lactating
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Ipsilateral Breast Tumor Recurrence-free Survival | Up to 5 years post-treatment completion, average of 48 months | Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Overall Survival | Up to 5 years post- completion of treatment, average 48 months | Overall survival rate at 5 years post-treatment completion. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Partial Breast Radiotherapy With Proton Beam Two weeks of proton beam radiotherapy to the lumpectomy site | 50 |
| Total | 50 |
Baseline characteristics
| Characteristic | Partial Breast Radiotherapy With Proton Beam | — |
|---|---|---|
| Age, Continuous | 63 years | — |
| ER Receptor Status ER- | 6 Participants | — |
| ER Receptor Status ER+ (>10% Tumor Cells Positive) | 44 Participants | — |
| Histology Ductal | 40 Participants | — |
| Histology Medullary | 1 Participants | — |
| Histology Mucinous | 5 Participants | — |
| Histology Tubular | 4 Participants | — |
| Involved Breast Left | 23 Participants | — |
| Involved Breast Right | 27 Participants | — |
| Race and Ethnicity Not Collected | — | — Participants |
| Sex: Female, Male Female | 50 Participants | — |
| Sex: Female, Male Male | 0 Participants | — |
| Tumor Size (cm) | 1.3 CM | — |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 2 / 50 |
| other Total, other adverse events | 0 / 50 |
| serious Total, serious adverse events | 49 / 50 |
Outcome results
Primary
Ipsilateral Breast Tumor Recurrence-free Survival
Lack of tumor recurrence in the treated breast as assessed by imaging and physical exam
Time frame: Up to 5 years post-treatment completion, average of 48 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Partial Breast Radiotherapy With Proton Beam | Ipsilateral Breast Tumor Recurrence-free Survival | 92 percentage of patients |
Secondary
Overall Survival
Overall survival rate at 5 years post-treatment completion.
Time frame: Up to 5 years post- completion of treatment, average 48 months
| Arm | Measure | Value (NUMBER) |
|---|---|---|
| Partial Breast Radiotherapy With Proton Beam | Overall Survival | 96 % Alive |