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 February 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: February 19, 2014
Last verified: February 2014
  Purpose

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.


Condition Intervention Phase
Breast Cancer
Breast Neoplasm
Breast Tumor
Cancer of the Breast
Radiation: Proton Radiotherapy
Phase 2

Study Type: Interventional
Study Design: Endpoint Classification: Safety/Efficacy Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Phase II Protocol of Proton Therapy for Partial Breast Irradiation in Early Stage Breast Cancer

Resource links provided by NLM:


Further study details as provided by Proton Collaborative Group:

Primary Outcome Measures:
  • 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.


Secondary Outcome Measures:
  • 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 ]

Estimated Enrollment: 42
Study Start Date: February 2013
Estimated Study Completion Date: January 2030
Estimated Primary Completion Date: January 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Proton Radiotherapy
Proton Radiotherapy 4.0 Gy (RBE) x10 fractions to 40 Gy (RBE) Total Dose
Radiation: Proton Radiotherapy

Detailed Description:

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.

  Eligibility

Ages Eligible for Study:   50 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Criteria

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01766297

Contacts
Contact: Megan Dunn, PhD 630-657-0092 megan.dunn@pcgresearch.org

Locations
United States, Illinois
CDH Proton Center Recruiting
Warrenville, Illinois, United States, 60555
Contact: Corey Woods, RN    630-821-6397    corey.woods@chi.procure.com   
Principal Investigator: Paige Dorn, MD         
United States, Oklahoma
Procure Proton Therapy Center Recruiting
Oklahoma City, Oklahoma, United States, 73142
Contact: Tish Adams, MS CCRC    405-773-6775    tish.adams@okc.procure.com   
Principal Investigator: Andrew Chang, MD         
Sponsors and Collaborators
Proton Collaborative Group
Investigators
Study Chair: Andrew Chang, MD Proton Collaborative Group
  More Information

No publications provided

Responsible Party: Proton Collaborative Group
ClinicalTrials.gov Identifier: NCT01766297     History of Changes
Other Study ID Numbers: BRE007-12
Study First Received: December 28, 2012
Last Updated: February 19, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by Proton Collaborative Group:
Breast Cancer
Proton
Radiation

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases

ClinicalTrials.gov processed this record on August 27, 2014