Clinical trial · Interventional

Partial Breast Radiation Therapy in Treating Women Undergoing Breast-Conserving Therapy for Early Stage Breast Cancer

Partial Breast Irradiation for Patients Undergoing Breast Conservation Therapy for Early Stage Breast Cancer: A Pilot Study

NCT00527293CI-TRIAL-00018930completedEarly Phase 1ClinicalTrials.gov clinicaltrialsPublishedExplore in graph →

Summary

Brief summary (as posted)

RATIONALE: Radiation therapy uses high-energy x-rays and other types of radiation to kill tumor cells. Giving radiation therapy in different ways may kill more tumor cells. PURPOSE: This clinical trial is studying how well partial breast radiation therapy works in treating women undergoing breast-conserving therapy for early stage breast cancer.

Conditions

Conditions (1)

Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.

Condition (as posted)	Mapped entity	Match	Confidence
Breast Cancer	Malignant Breast Neoplasm	CURATED_EXACT	0.92

Interventions

Interventions (3)

Intervention	Type	Mapped drug	Match
3-dimensional conformal radiation therapy	Radiation	—	UNRESOLVED
adjuvant therapy	Procedure	—	UNRESOLVED
brachytherapy	Radiation	—	UNRESOLVED

Design

Arms and outcomes

Arms (2)

type
EXPERIMENTAL
label
MammoSite Brachytherapy
description
Patients undergo partial breast irradiation comprising either MammoSite® brachytherapy twice daily for 5-10 days
interventionNames
1. Procedure: adjuvant therapy
2. Radiation: brachytherapy
type
EXPERIMENTAL
label
3-dimensional conformal radiotherapy
description
3-dimensional conformal radiotherapy twice daily for 5-10 days.
interventionNames
1. Procedure: adjuvant therapy
2. Radiation: 3-dimensional conformal radiation therapy

Primary outcomes (5)

measure
Cosmetic outcome as determined by an established scale employed by the radiation oncologist and the surgeon

Eligibility

Eligibility (as posted)

Sex: Female
Minimum age: 18 Years

Show eligibility criteria text

DISEASE CHARACTERISTICS:

* Histologically confirmed breast cancer, including the following histologic subtypes:

  * Invasive ductal carcinoma
  * Medullary ductal carcinoma
  * Papillary ductal carcinoma
  * Colloid (mucinous) ductal carcinoma
  * Tubular ductal carcinoma
* The following histologic subtypes are not allowed:

  * Invasive lobular carcinoma
  * Extensive lobular carcinoma in situ
  * Ductal carcinoma in situ (DCIS)
  * Nonepithelial breast malignancies, such as lymphoma or sarcoma
* No extensive intraductal component by Harvard definition (i.e., more than 25% of the invasive tumor is DCIS or DCIS present in adjacent tissue)
* Stage I or II disease (T1, N0; T1, N1a; T2, N0; or T2, N1a)

  * Lesion ≤ 3 cm
  * No more than 3 positive lymph nodes

    * Patients with 4 or more positive axillary lymph nodes found at the time of axillary lymph node dissection/sentinel lymph node biopsy are not eligible
* Has undergone tylectomy (lumpectomy) and axillary lymph node sampling (axillary node dissection or sentinel node biopsy)

  * Negative resection margins with ≥ 2 mm margin from invasive or in situ cancer OR a negative re-excision margin
* Unifocal breast cancer

  * No multicentric carcinoma (tumors in different quadrants of the breast or tumors separated by ≥ 4 cm)

    * No palpable or radiographically suspicious contralateral axillary, ipsilateral or contralateral supraclavicular, infraclavicular, or internal mammary lymph nodes unless these are histologically confirmed negative
* No skin involvement of disease
* No Paget's disease of the nipple
* No distant metastatic disease
* Hormone-receptor status not specified

PATIENT CHARACTERISTICS:

* Female
* Menopausal status not specified
* Not pregnant or lactating
* Negative pregnancy test
* Fertile patients must use effective contraception for ≥ 1 week prior to, during, and for ≥ 2 weeks after completion of study treatment
* No collagen vascular disorders, specifically systemic lupus erythematosus, scleroderma, or dermatomyositis
* No psychiatric, neurologic, or addictive disorders that would preclude obtaining informed consent
* No other malignancy within the past 5 years, except non-melanomatous skin cancer

PRIOR CONCURRENT THERAPY:

* No prior radiotherapy to the breast
* No chemotherapy for at least 2 weeks before and 2 weeks after completion of study radiotherapy
* Concurrent hormonal therapy allowed

References

Publications (0)

Data not yet available

No reference posted for this study.

Registry

Dates and enrollment

Start: Jun 1, 2007
Primary completion: Oct 1, 2010
Completion: Feb 1, 2015
First posted: Sep 10, 2007
Last update posted: Aug 25, 2015
Enrollment: 29 (actual)
Lead sponsor: Case Comprehensive Cancer Center OTHER
Collaborators: National Cancer Institute (NCI)
Keywords: stage I breast cancer, stage II breast cancer, invasive ductal breast carcinoma, medullary ductal breast carcinoma with lymphocytic infiltrate, mucinous ductal breast carcinoma, tubular ductal breast carcinoma, papillary ductal breast carcinoma

Data updated 22 days agoSource updated Aug 25, 2015source: clinicaltrials

Locations

Locations by country (4)

Country	Sites	Recruiting
United States	4	0

Trial listing is informational. Eligibility is decided by the study team; contact information is on ClinicalTrials.gov.