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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT02076074
Recruitment Status : Active, not recruiting
First Posted : March 3, 2014
Last Update Posted : April 12, 2018
Information provided by (Responsible Party):
Washington University School of Medicine

Brief Summary:
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 or disease Intervention/treatment Phase
Breast Neoplasms Radiation: accelerated partial breast irradiation Phase 1 Phase 2

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.

Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 50 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : April 2, 2014
Estimated Primary Completion Date : April 13, 2023
Estimated Study Completion Date : April 13, 2023

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
U.S. FDA Resources

Arm Intervention/treatment
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

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

  2. Proportion of patients who are free of breast cancer in the treated breast [ Time Frame: Up to 5 years ]
    Rate of patients without ipsilateral breast tumor recurrences (IBTR). Calculated with a 95% confidence interval.

Secondary Outcome Measures :
  1. Proportion of patients who are free of breast cancer in the regional lymph nodes [ Time Frame: Up to 5 years ]
    Ipsilateral axilla, infraclavicular, supraclavicular, and internal mammary groups. Calculated with a 95% confidence interval.

  2. Proportion of patients who are free from distant metastases [ Time Frame: Up to 5 years ]
  3. Quality of life [ Time Frame: Up to 5 years ]
    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.

  4. Cosmesis as measured quantitatively [ Time Frame: Up to 5 years ]
    BRA and pBRA scores are calculated. pBRA scores will be plotted at the assessment time points and presented graphically.

  5. Cosmesis as measured qualitatively [ Time Frame: Up to 5 years ]
    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.

  6. Proportion of patients surviving [ Time Frame: Up to 5 years ]
  7. Presence of complications using CTCAE v. 4.0 [ Time Frame: Up to 5 years ]
    Complications will be tabulated and frequencies presented graphically.

  8. Frequency of any grade 3-4 toxicities using CTCAE v4.0 [ Time Frame: Up to 5 years ]
  9. Proportion of patients undergoing mastectomy [ Time Frame: Up to 5 years ]
    The rate of mastectomy within five years of HG-PBI treatment will be calculated with a 95% confidence interval.

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Ages Eligible for Study:   50 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT02076074

United States, Missouri
Washington University School of Medicine
Saint Louis, Missouri, United States, 63110
Sponsors and Collaborators
Washington University School of Medicine
Principal Investigator: Imran Zoberi, M.D. Washington University School of Medicine

Additional Information:
Responsible Party: Washington University School of Medicine Identifier: NCT02076074     History of Changes
Other Study ID Numbers: 201401160
First Posted: March 3, 2014    Key Record Dates
Last Update Posted: April 12, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: Yes
Device Product Not Approved or Cleared by U.S. FDA: No
Pediatric Postmarket Surveillance of a Device Product: No
Product Manufactured in and Exported from the U.S.: No

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