Single Fraction High-Gradient Partial Breast Irradiation in Treating Patients With Low-Risk Stage 0-I Breast Cancer

This study is currently recruiting participants. (see Contacts and Locations)
Verified April 2014 by Washington University School of Medicine
Sponsor:
Information provided by (Responsible Party):
Washington University School of Medicine
ClinicalTrials.gov Identifier:
NCT02076074
First received: February 27, 2014
Last updated: April 23, 2014
Last verified: April 2014
  Purpose

This phase I/II clinical trial studies the side effects of delivering radiation therapy in a single session instead of multiple treatments over several weeks and to see how well it works in treating patients with low-risk stage 0-I breast cancer. Partial-breast irradiation, a type of radiation therapy focused only to the part of the breast that has cancer in it, given at a lower dose than standard whole-breast radiation therapy. Single fraction high-gradient partial-breast irradiation may cause fewer side effects, help prevent breast cancer from coming back, and improve the appearance of the breast and quality of life of patients with breast cancer.


Condition Intervention Phase
Breast Neoplasms
Radiation: accelerated partial breast irradiation
Phase 1
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: Evaluation of Single Fraction High-Gradient Partial Breast Irradiation as the Sole Method of Radiation Therapy for Low-Risk Stage 0 and I Breast Carcinoma

Resource links provided by NLM:


Further study details as provided by Washington University School of Medicine:

Primary Outcome Measures:
  • Proportion of patients who are free of serious treatment related toxicity [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
    Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity per CTCAE, version 4.0

  • Proportion of patients who are free of breast cancer in the treated breast [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Rate of patients without ipsilateral breast tumor recurrences (IBTR). Calculated with a 95% confidence interval.


Secondary Outcome Measures:
  • Proportion of patients who are free of breast cancer in the regional lymph nodes [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups. Calculated with a 95% confidence interval.

  • Proportion of patients who are free from distant metastases [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Quality of life [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Measured by the EORTC QLQ-C30, QLQ-BR23, and the Visual Analog Scale for Pain. Each of the subscales will be tabulated and presented graphically over the assessment times. Mixed repeated measures models will be generated to describe the nature of change in quality of life over time.

  • Cosmesis as measured quantitatively [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    BRA and pBRA scores are calculated. pBRA scores will be plotted at the assessment time points and presented graphically.

  • Cosmesis as measured qualitatively [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Using the Aronson modified Harris scale. Assessed by patients and physicians. The two sets of scores will be plotted using histograms. Kappa statistics with 95% confidence intervals will be calculated to assess the agreement between patient and physician scores before treatment, at 4-6 months at 1 year, and at subsequent visits.

  • Proportion of patients surviving [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
  • Presence of complications using CTCAE v. 4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    Complications will be tabulated and frequencies presented graphically.

  • Frequency of any grade 3-4 toxicities using CTCAE v4.0 [ Time Frame: Up to 5 years ] [ Designated as safety issue: Yes ]
  • Proportion of patients undergoing mastectomy [ Time Frame: Up to 5 years ] [ Designated as safety issue: No ]
    The rate of mastectomy within five years of HG-PBI treatment will be calculated with a 95% confidence interval.


Estimated Enrollment: 50
Study Start Date: April 2014
Estimated Study Completion Date: April 2027
Estimated Primary Completion Date: April 2022 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Treatment (HG-PBI)
Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.
Radiation: accelerated partial breast irradiation
Undergo HG-PBI
Other Name: APBI

Detailed Description:

This is a phase I/II study which will evaluate the complication rates, local control, cosmetic results, and quality of life of single fraction high gradient partial breast irradiation (HG-PBI) when used as the sole method of radiation therapy for patients with pathologic stage 0 (=< 2 cm) or I carcinoma of the breast treated with partial mastectomy with histologically assessed negative surgical margins.

  Eligibility

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

Inclusion Criteria:

  • AJCC 7th Edition stage 0 or I (TisN0 ≤ 2 cm or T1N0) histologically confirmed carcinoma of the breast, treated with partial mastectomy. Axillary sampling is required only for cases of invasive cancers. Tumor size is determined by the pathologist. Clinical size may be used if the pathologic size is indeterminate. Patients with invasive cancer must have no positive axillary lymph nodes with at least 6 axillary lymph nodes sampled or a negative sentinel node.
  • Negative histologic margins of partial mastectomy or re-excision specimen. Margins generally are positive if there is invasive or noninvasive tumor at the inked resection margin, close but negative if the tumor is within 2 mm of the inked margin and negative if the tumor is at least 2 mm away from the inked edge.
  • Invasive ductal, lobular, medullary, papillary, colloid (mucinous), tubular histologies, or mixed histologies (lesions ≤ 2 cm) that are estrogen or progesterone receptor positive and do not exhibit HER2/neu gene amplification OR ductal carcinoma in situ (lesions ≤ 2 cm).
  • Systemic therapy, if planned, must be adjuvant in nature and not be scheduled to begin for at least 4 weeks after completion of HG-PBI.
  • Good candidate for treatment per protocol in the judgment of the PI and/or treating physician following simulation.
  • Postmenopausal status.
  • Age ≥ 50 years at diagnosis.
  • Able to understand and willing to sign IRB-approved written informed consent document.
  • English speaker.

Exclusion Criteria:

  • Presence of distant metastases.
  • In situ lobular carcinoma or nonepithelial breast malignancies such as sarcoma or lymphoma.
  • Proven multicentric carcinoma (tumors in different quadrants of the breast, or tumors separated by at least 4 cm) with other clinically or radiographically suspicious areas in the ipsilateral breast unless confirmed to be negative for malignancy by biopsy.
  • Premenopausal status.
  • Histologically confirmed positive axillary nodes in the ipsilateral axilla. Palpable or radiographically suspicious contralateral axillary, supraclavicular, infraclavicular, or internal mammary nodes, unless there is histologic confirmation that these nodes are negative for tumor.
  • Prior non-hormonal therapy for the present breast cancer, including radiation therapy or chemotherapy.
  • Diagnosis of systemic lupus erythematosis, scleroderma, or dermatomyositis.
  • Diagnosis of a coexisting medical condition which limits life expectancy to < 2 years.
  • Diagnosis of psychiatric or addictive disorders that would preclude obtaining informed consent.
  • History of other malignancy ≤ 5 years previous with the exception of basal cell or squamous cell carcinoma of the skin which were treated with local resection only or carcinoma in situ of the cervix.
  • Paget's disease of the nipple.
  • Skin involvement, regardless of tumor size.
  • Unsatisfactory breast for HG-PBI as determined by the treating physician. For example, if there is little breast tissue remaining between the skin and pectoralis muscle after surgery, treatment with HG-PBI is technically problematic.
  • Partial mastectomy so extensive that the cosmetic result is fair or poor prior to HG-PBI as determined by the treating physician.
  • Surgical margins which cannot be microscopically assessed or are positive at pathological evaluation.
  • Time between final definitive breast procedure to HG-PBI simulation is greater than 8 weeks.

Inclusion of Women and Minorities

-Women and members of all races and ethnic groups are eligible for this trial. Because breast cancer occurs rarely in men, men will not be recruited for participation.

  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: NCT02076074

Contacts
Contact: Imran Zoberi, M.D. 314-362-8610 izoberi@radonc.wustl.edu

Locations
United States, Missouri
Washington University School of Medicine Recruiting
St. Louis, Missouri, United States, 63110
Contact: Imran Zoberi, M.D.    314-362-8610    izoberi@radonc.wustl.edu   
Sub-Investigator: Maria Thomas, M.D., Ph.D.         
Sub-Investigator: Laura Ochoa, ANP, Ph.D.         
Sub-Investigator: Rojano Kashani, Ph.D.         
Sub-Investigator: Julie Margenthaler, M.D.         
Sub-Investigator: Souzan Sanati, M.D.         
Sub-Investigator: Todd DeWees, Ph.D.         
Sponsors and Collaborators
Washington University School of Medicine
Investigators
Principal Investigator: Imran Zoberi, M.D. Washington University School of Medicine
  More Information

Additional Information:
No publications provided

Responsible Party: Washington University School of Medicine
ClinicalTrials.gov Identifier: NCT02076074     History of Changes
Other Study ID Numbers: 201401160
Study First Received: February 27, 2014
Last Updated: April 23, 2014
Health Authority: United States: Institutional Review Board

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

ClinicalTrials.gov processed this record on August 20, 2014