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Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Phase 2
50 Years
Open (Enrolling)
Breast Cancer, Breast Neoplasm, Breast Tumor, Cancer of the Breast

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Trial Information

Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Current standard of care for early stage breast cancer is mastectomy or breast conserving
therapy with whole breast irradiation following lumpectomy. However, studies of breast
cancer recurrence have demonstrated the majority of tumors to recur in or adjacent to the
original tumor site. The question has thus been raised as to whether radiation to the whole
breast is necessary or justified. Limiting radiation to the area of the original tumor may
reduce acute and long-term skin and organ toxicities while making radiation therapy more
convenient and less expensive. Several clinical trials are underway comparing partial breast
irradiation (PBI) to whole breast irradiation. Numerous centers are offering partial breast
irradiation outside of clinical trials as well, despite the lack of long-term safety and
efficacy data on PBI.

Available PBI methods include brachytherapy, in which catheters or balloons are surgically
inserted to deliver radiation therapy to the lumpectomy cavity, and conventional external
beam radiation therapy, or EBRT. External beam photon therapy is attractive for its
non-invasive nature and ability to deliver a more homogenous dose distribution compared to
brachytherapy, however it also delivers a greater radiation dose to surrounding normal
breast tissue.Proton therapy has the capacity to provide the same advantages as photon EBRT
while minimizing dose to normal surrounding tissue. Clinical data on PBI with protons is
minimal, however, leaving many questions unanswered. The impetus behind this protocol is to
address these gaps by further investigating the feasibility, safety, and efficacy of proton
therapy for partial breast irradiation.

Inclusion Criteria:

- 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 and encompassed within a single scar (b) Patient
does not have microscopically multifocal tumor.

- In the presence of extensive intraductal component (EIC) the entire pathologic tumor
size (including both the intraductal and invasive component) are 3.0 cm or less.

- Must be Stage 0, I, II (T1-2, N0, M0 per AJCC criteria 7th 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.

- HER2 performed and report available. (Positive or negative is acceptable).

- Must have Oncotype performed on core or lumpectomy and the results documented.

- Must have a lumpectomy performed, with documented negative surgical margins > 0.2 cm.
If re-excision results in negative surgical margins > 0.2 cm, patient is eligible.

- Must be prepared to have 3 fiducial markers minimum, 4 preferred placed prior to
treatment if not previously done.

- If markers or clips were placed at the time of surgery, must be able to start
treatment within 12 weeks after lumpectomy or re-excision for clean margins.

- If markers were not placed at the time of surgery, must have markers placed
within 6 weeks after surgery.

- If systemic chemotherapy was given patients must have had clips or markers
placed at the time of surgery and 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

Exclusion Criteria:

- 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 microcalcifications of either breast, unless negative for malignancy on

- 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.

- Ipsilateral breast implant unless removed prior to radiation treatment.

- 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 erythematosis, scleroderma, or dermatomysositis.

- Known BRCA 1 or BRCA 2 mutation.

- Pregnant or lactating

Type of Study:


Study Design:

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

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.

Outcome Description:

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 ≥ 15% (FFF ≤ 85%) is considered unacceptable. Therefore, the null hypothesis is the FFF of ipsilateral breast cancer recurrence is 85% or lower and the alternative hypothesis is that FFF of ipsilateral breast cancer is 97% or higher.

Outcome Time Frame:

At 3 years

Safety Issue:


Principal Investigator

Andrew Chang, MD

Investigator Role:

Study Chair

Investigator Affiliation:

Proton Collaborative Group


United States: Institutional Review Board

Study ID:




Start Date:

February 2013

Completion Date:

January 2030

Related Keywords:

  • Breast Cancer
  • Breast Neoplasm
  • Breast Tumor
  • Cancer of the Breast
  • Breast Cancer
  • Proton
  • Radiation
  • Breast Neoplasms
  • Neoplasms



ProCure Proton Therapy Center Warrenville, Illinois  60555
ProCure Proton Therapy Center Oklahoma City, Oklahoma  73142