NCT01008514

Brief Summary

RATIONALE: Internal radiation therapy uses radioactive material placed directly into or near a tumor to kill tumor cells. It may also cause less damage to normal tissue. PURPOSE: This phase II trial is studying how well partial-breast radiation therapy works in treating women with early-stage breast cancer.

Trial Health

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

November 4, 2009

Completed
1 day until next milestone

First Posted

Study publicly available on registry

November 5, 2009

Completed
Last Updated

March 26, 2015

Status Verified

March 1, 2015

First QC Date

November 4, 2009

Last Update Submit

March 25, 2015

Conditions

Breast Cancer

Keywords

ductal breast carcinoma in situstage IA breast cancerstage IB breast cancerstage II breast cancer

Outcome Measures

Primary Outcomes (1)

  • Proportion of local recurrence

    * Local recurrence is defined as either invasive or non-invasive local recurrence within the target volume. * Ipsilateral elsewhere recurrence is defined as either invasive or non-invasive local recurrence outside of the target volume.

    up to 5 years

Secondary Outcomes (2)

  • Safety and toxicity

    up to 30 months after radiotherapy

  • Cosmetic results

    up to 30 months

Interventions

adjuvant therapyPROCEDURE
accelerated partial breast irradiationRADIATION
intracavitary balloon brachytherapyRADIATION

Eligibility Criteria

Age45 Years+
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
DISEASE CHARACTERISTICS: * Histologically confirmed ductal carcinoma in situ (DCIS) of the breast or invasive breast adenocarcinoma * Stage 0, I, or II (T2, N0; tumor size ≤ 3 cm) disease * Pathologic staging of the axilla preferred * Clinical staging of the axilla allowed for patients ≥ 70 years of age with hormone receptor-positive tumors * Unicentric tumor * Microscopic multifocality allowed as long as the total tumor size is ≤ 3 cm * Must have undergone lumpectomy as definitive surgery * Negative surgical margins, defined as no tumor at the inked margin of resection after final surgery * Re-excision to obtain negative margins allowed * Must have adequate skin spacing between balloon surface and surface of the skin and lung (≥ 7 mm) * No multicentric carcinoma (invasive or DCIS) in more than one quadrant * No clinically or pathologically positive regional lymph nodes * No extensive intraductal component, defined as DCIS extending beyond the primary invasive component into normal breast parenchyma and composing \> 25% of the primary tumor * Hormone receptor status not specified PATIENT CHARACTERISTICS: * Menopausal status not specified * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * No collagen-vascular disease, including any of the following: * Dermatomyositis * Systemic lupus erythematosus * Scleroderma-mixed connective tissue disease PRIOR CONCURRENT THERAPY: * See Disease Characteristics

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

Related Links

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma, Intraductal, Noninfiltrating

Interventions

Chemotherapy, Adjuvant

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesAdenocarcinomaCarcinomaNeoplasms, Glandular and EpithelialNeoplasms by Histologic TypeBreast Carcinoma In SituCarcinoma in SituNeoplasms, Ductal, Lobular, and Medullary

Intervention Hierarchy (Ancestors)

Combined Modality TherapyTherapeuticsDrug Therapy

Study Officials

  • Edward Kim, MD

    Ohio State University Comprehensive Cancer Center

    PRINCIPAL INVESTIGATOR
0

Study Design

Study Type
interventional
Phase
phase 2
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 4, 2009

First Posted

November 5, 2009

Last Updated

March 26, 2015

Record last verified: 2015-03