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

NCT02076074 | Completed Results DMC FDA Device

• 1 other identifier: 201401160
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Neoplasms

Outcome Measures

Primary Outcomes (2)

• Percentage of Patients Who Are Free of Serious Treatment Related Toxicity

  Quantified by estimating the rate of acute and late treatment-related grade 3 or higher toxicity (per CTCAE, v.4.0) or any other grade 4 or 5 toxicity attributed to the therapy. Toxicities of concern include breast pain, delayed wound healing, persistent seroma fluid accumulation, breast fibrosis and fat necrosis in the treated breast. Rare toxicities include radiation pneumonitis and pericarditis. Acute toxicities are defined as toxicities that occurred from start of treatment until day 90. Late toxicities are defined as toxicities that occurred from Day 91 until completion of 5 year follow-up.

  Up to 5 years

• Percentage of Patients Who Are Free of Breast Cancer in the Treated Breast

  Percentage of patients without ipsilateral breast tumor recurrences (IBTR).

  At 5 years

Secondary Outcomes (11)

• Percentage of Patients Who Are Free of Breast Cancer in the Regional Lymph Nodes

  At 5 years

• Percentage of Patients Who Are Free From Distant Metastases

  At 5 years

• Change in Quality of Life as Measured by the Mean Change From Baseline - EORTC QLC-C30

  2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5

• Change in Quality of Life as Measured by the Mean Change From Baseline - QLQ-BR23

  2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5

• Change in Quality of Life as Measured by the Mean Change From Baseline - Visual Analog Scale for Pain

  2 weeks, 8 weeks, 6 months, 12 months, 18 months, 24 months, 36 months, year 4, and year 5

Study Arms (1)

Treatment (HG-PBI)

EXPERIMENTAL

Patients undergo single fraction high gradient-partial breast irradiation within 8 weeks after partial mastectomy.

Radiation: accelerated partial breast irradiation

Interventions

accelerated partial breast irradiation RADIATION

Undergo HG-PBI

Also known as: APBI

Treatment (HG-PBI)

Eligibility Criteria

• Age: 50 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Washington University School of Medicine: lead

Study Sites (1)

Washington University School of Medicine

St Louis, Missouri, 63110, United States

Location

Related Links

• Alvin J. Siteman Cancer Center at Barnes-Jewish Hospital and Washington University School of Medicine

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Imran Zoberi, M.D.
• Organization: Washington University School of Medicine

izoberi@wustl.edu

314-362-8610

Study Officials

• Imran Zoberi, M.D.

  Washington University School of Medicine

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 27, 2014
• First Posted: March 3, 2014
• Study Start: April 2, 2014
• Primary Completion: May 18, 2023
• Study Completion: May 18, 2023
• Last Updated: July 11, 2024
• Results First Posted: July 11, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)