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📋 OverviewThis is a Phase II interventional study titled "Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer." It aims to evaluate the safety and effectiveness of proton radiation therapy specifically delivered to a part of the breast, rather than the whole breast, for women diagnosed with early-stage breast cancer. The study is currently RECRUITING participants and is expected to be completed by January 2033. 🔬 Terminology Explained
🎯 PurposeThe primary purpose of this study is to assess the effectiveness of proton therapy for partial breast irradiation by measuring the rate of freedom from ipsilateral breast recurrence (meaning, the cancer not returning in the same breast) at 3 years. It also aims to evaluate the safety of this treatment by tracking acute and long-term side effects, and to assess the impact on patients' quality of life. The study seeks to determine if proton therapy can offer the benefits of partial breast irradiation (like convenience and reduced side effects) while minimizing radiation dose to healthy tissues. 🧪 Study DesignThis is a Phase II, single-group, interventional treatment study.
✅ Participation/EligibilityThis study is specifically for female patients aged 50 years or older with early-stage breast cancer.
📢 Check the Trial Radar Card View 'Participation' tab for complete Eligibility details. 📊 Outcomes Being MeasuredThe study measures several outcomes to determine the effectiveness and safety of the treatment:
📢 Check the Trial Radar Card View 'Study Plan' tab for complete Outcome details. 📈 Related Research & TrendsCurrent standard care for early-stage breast cancer often involves whole breast irradiation after lumpectomy. However, research shows that most recurrences happen near the original tumor site. This has led to interest in PBI methods, which aim to reduce side effects and treatment time by targeting only the tumor bed. While various PBI methods exist, including brachytherapy and conventional external beam radiation (photon therapy), proton therapy is being explored for its potential to deliver a highly precise dose while sparing more healthy tissue. This study is crucial for gathering more clinical data on the feasibility, safety, and efficacy of proton therapy for PBI, as current data is limited. This trial is important because it could potentially offer a less toxic and more convenient radiation option for women with early-stage breast cancer, improving their quality of life while maintaining effective cancer control. It is always recommended to discuss any clinical trial information with your healthcare provider to understand if it might be suitable for your individual health situation. One study matched filter criteria. | ||
Proton Collaborative GroupPhase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer Phase 2 132
This study is being done to see if proton radiation therapy will prove to be beneficial for women with early stage breast cancer. A clinical study is necessary to compare the results (good or bad) of proton radiation therapy.
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
- BRE007-12
Proton
Radiation
| Participant Group/Arm | Intervention/Treatment |
|---|---|
ExperimentalProton Radiotherapy Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose | Proton Radiotherapy |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
To assess events of freedom from ipsilateral breast recurrence occurrences in patients receiving partial breast proton radiation therapy limited to the region of the tumor. | Freedom from failure (FFF): The events for FFF will be the first ipsilateral breast cancer recurrence. It is expected that less than 3% of patients will experience an ipsilateral breast cancer recurrence (FFF ≥ 97%). A recurrence rate of ≥ 10% (FFF ≤ 90%) is considered unacceptable. Therefore, the null hypothesis is the FFF of ipsilateral breast cancer recurrence is 90% or lower and the alternative hypothesis is that FFF of ipsilateral breast cancer is 97% or higher. | At 3 years |
| Outcome Measure | Measure Description | Time Frame |
|---|---|---|
Assess number and severity of acute and long-term toxicity of partial breast irradiation using proton therapy for the treatment of early stage breast cancer. | On average every 6 months for life | |
To assess relationship between breast size and partial breast dosimetry. | Average every 6 months for 3 years | |
Determine quality of life results. | Average every 6 months for 3 years | |
To determine overall survival rate of patients with breast cancer treated with proton radiation. | At 3 years | |
To determine recurrence pattern of patients with breast cancer treated with proton partial breast irradiation. | At 3 years |
Must sign study-specific, IRB approved informed consent form prior to study entry. Note consent by legally authorized representative is not allowed for this trial.
Must be female.
Must be > = 50 years of age.
Must have a life expectancy of at least 5 years based on age and co-morbidities.
Must have pathology proven invasive ductal carcinoma (lobular is not allowed) and/or ductal carcinoma in situ (DCIS).
One of the following criteria must be met: (a) Tumors that are microscopically multifocal must be 3.0 cm or less in total aggregate size and encompassed within a single scar (b) Patient does not have microscopically multifocal tumor.
For tumors that are invasive, if in the presence of extensive intraductal component (EIC), the entire pathologic tumor size (including both the intraductal and invasive component) must be 3.0 cm or less.
Must be Stage 0, I, II (Tis, T1, or T2, N0, M0 per AJCC criteria 7th and/or 8th Ed.). If stage II, the tumor size must be < = 3.0 cm. A patient with invasive histology must have nodal stage pN0 by H&E stains on sentinel node biopsy or axillary lymph node dissection.
Must have ER positive disease with ER/PR report available.
For tumors that are invasive, HER2 must be performed (positive or negative is acceptable).
Must have a lumpectomy performed, with documented negative surgical margins by 0.2 cm or more. If re-excision results in negative surgical margins 0.2 cm or more, patient is eligible.
If image guidance with daily cone beam CT with direct physician visual assessment is used for treatment positioning, the presence of markers or clips in the surgical bed is recommended but not required. If cone beam CT imaging will NOT be used for image guidance, then the patient must be prepared to have 2 fiducial markers minimum, 3 preferred, placed prior to treatment (if not previously done).
- If markers or clips were placed at the time of surgery, patient must be able to start treatment within 12 weeks after lumpectomy or re-excision for adequate margins.
- If markers were not placed at the time of surgery and are needed, patient must have markers placed within 6 weeks after surgery.
- If systemic chemotherapy was given, patient must have had clips or markers placed at the time of surgery (if they are needed) and patient must have simulation scans within 6 weeks of the completion of the chemotherapy.
Must be able to start treatment within 12 weeks of surgery or 8 weeks of finalization of chemotherapy.
- Previous history of ipsilateral invasive breast cancer or DCIS.
- Any clinical or radiographically suspicious nodes, unless biopsy proven benign.
- Non-epithelial malignancies such as sarcoma or lymphoma.
- Suspicious residual microcalcifications on mammography of either breast, unless negative for malignancy on pathology.
- Multicentric or bilateral disease unless biopsy of the clinical abnormalities are performed and result is negative.
- Lymphovascular space invasion (LVSI) on pathology specimen.
- Any previously treated breast carcinoma or synchronous breast carcinoma in ipsilateral breast.
- Prior radiation therapy to the ipsilateral breast or thorax.
- Paget's disease of the nipple.
- Histologic examination showing invasive lobular histology.
- Skin involvement.
- Breasts technically unsatisfactory for radiation treatment upon the discretion of the treating physician.
- Significant infection or other co-existing medical condition that would preclude protocol therapy such as pregnancy, HIV/AIDS or collagen vascular diseases specifically systemic lupus erythematosus, scleroderma, or dermatomyositis.
- Known BRCA 1 or BRCA 2 mutation.
- Pregnant or lactating.
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