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

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2014 by Proton Collaborative Group
Sponsor:
Information provided by (Responsible Party):
Proton Collaborative Group
ClinicalTrials.gov Identifier:
NCT01766297
First received: December 28, 2012
Last updated: September 4, 2014
Last verified: September 2014

December 28, 2012
September 4, 2014
February 2013
January 2022   (final data collection date for primary 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. [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
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.
Same as current
Complete list of historical versions of study NCT01766297 on ClinicalTrials.gov Archive Site
  • 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. [ Time Frame: On average every 6 months for life ] [ Designated as safety issue: Yes ]
  • To assess relationship between breast size and partial breast dosimetry. [ Time Frame: Average every 6 months for 3 years ] [ Designated as safety issue: No ]
  • Compare freedom from failure, survival and dosimetry of post-operative vs. pre-operative partial breast irradiation. [ Time Frame: At 3 years ] [ Designated as safety issue: No ]
  • Determine quality of life results [ Time Frame: Average every 6 months for 3 years ] [ Designated as safety issue: No ]
  • To determine overall survival rate of patients with breast cancer treated with proton radiation [ Time Frame: at 3 years ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer
Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

The purpose of this research study is to compare the effects (good and bad) on women and their cancer using proton radiation therapy.

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.

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.

Interventional
Phase 2
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
  • Breast Cancer
  • Breast Neoplasm
  • Breast Tumor
  • Cancer of the Breast
Radiation: Proton Radiotherapy
Experimental: Proton Radiotherapy
Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose
Intervention: Radiation: Proton Radiotherapy
Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruiting
42
January 2030
January 2022   (final data collection date for primary outcome measure)

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 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.
  • 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
Female
50 Years and older
No
Contact: Megan Dunn, PhD 630-657-0092 megan.dunn@pcgresearch.org
United States
 
NCT01766297
BRE007-12
Yes
Proton Collaborative Group
Proton Collaborative Group
Not Provided
Study Chair: Andrew Chang, MD Proton Collaborative Group
Proton Collaborative Group
September 2014

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP