APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer

This study is ongoing, but not recruiting participants.

Sponsor:

ClinicalTrials.gov Identifier:

NCT00402519

First Posted: November 22, 2006

Last Update Posted: May 13, 2016

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.

Information provided by (Responsible Party):

University of Erlangen-Nürnberg Medical School

Tracking Information

First Submitted Date ^ICMJE

November 21, 2006

First Posted Date ^ICMJE

November 22, 2006

Last Update Posted Date

May 13, 2016

Start Date ^ICMJE

November 2004

Primary Completion Date

November 2009 (Final data collection date for primary outcome measure)

Current Primary Outcome Measures ^ICMJE

Local control [ Time Frame: 5-years, 10 ten-years ]

Original Primary Outcome Measures ^ICMJE

Local control

Change History

Complete list of historical versions of study NCT00402519 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^ICMJE

Incidence and severity of acute and late side effects [ Time Frame: 5-years ]
Differences in cosmetic results [ Time Frame: 5-years ]
Distant metastases free survival [ Time Frame: 5-years ]
Survival rates (Overall Survival, Disease-free Survival) [ Time Frame: 5-years ]
Contralateral breast cancer rate [ Time Frame: 5-years ]
Quality-of-Life [ Time Frame: 5-years ]

Original Secondary Outcome Measures ^ICMJE

Incidence and severity of acute and late side effects
Differences in cosmetic results
Distant metastases free survival
Survival rates (Overall Survival, Disease-free Survival)
Contralateral breast cancer rate
Quality-of-Life

Current Other Outcome Measures ^ICMJE

Not Provided

Original Other Outcome Measures ^ICMJE

Not Provided

Descriptive Information

Brief Title ^ICMJE

APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer

Official Title ^ICMJE

Interstitial Brachytherapy Alone Versus External Beam Radiation Therapy After Breast Conserving Surgery for Low-risk Invasive Carcinoma and Low-risk Ductal Carcinoma in Situ (DCIS) of the Female Breast

Brief Summary

To assess the role of interstitial brachytherapy alone compared to whole breast irradiation in a defined low-risk group of invasive breast cancer or ductal carcinoma in situ concerning local failure (all ipsilateral local recurrences) to affirm the hypothesis that local control rates in each arm are equivalent.

Detailed Description

Study Type ^ICMJE

Interventional

Study Phase

Phase 3

Study Design ^ICMJE

Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment

Condition ^ICMJE

Breast Cancer

Intervention ^ICMJE

Radiation: Accelerated partial breast irradiation
APBI with PDR and HDR brachytherapy
Radiation: External beam whole breast irradiation
Standard Whole breast irradiation

Study Arms

Experimental: APBI
Accelerated Partial Breast Irradiation with multicatheter brachytherapy

Intervention: Radiation: Accelerated partial breast irradiation
Active Comparator: EBRT
Standard External Beam Whole Breast Irradiation

Intervention: Radiation: External beam whole breast irradiation

Publications *

* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.

Recruitment Information

Recruitment Status ^ICMJE

Active, not recruiting

Enrollment ^ICMJE

1300

Estimated Completion Date

November 2019

Primary Completion Date

November 2009 (Final data collection date for primary outcome measure)

Eligibility Criteria ^ICMJE

Inclusion Criteria:

Stage 0, I or II breast cancer.
Invasive ductal, papillary, mucinous, tubular, medullary or lobular carcinoma.
Ductal carcinoma in situ (DCIS) alone.
No lymph invasion (L0) and no hemangiosis (V0).
Lesions of > 3 cm diameter, histopathologically confirmed.
pN0/pNmi (a minimum of 6 nodes in specimen, or a negative sentinel node is acceptable); in the case of DCIS alone axillary staging (e.g. sentinel lymph node biopsy) is optional.
M0.
Clear resection margins at least 2 mm in any direction; by lobular histology or DCIS histology only the resection margins must be clear at least 5 mm.
For DCIS only: lesions must be classified as low or intermediate risk group (Van Nuys Prognostic Index <8).
Unifocal and unicentric DCIS or breast cancer.
Age >= 40 years.
Time interval from final definitive breast surgical procedure to the start of external beam therapy or to brachytherapy is less than 12 weeks (84 days). If patients receive chemotherapy the radiotherapy can be started before systemic treatment (within 12 weeks). The radiation therapy can be also given in the interval between the chemotherapy courses. It is also possible to start radiation therapy after chemotherapy is completed according local protocols as soon as possible within 4 weeks after chemotherapy.
Signed study-specific consent form prior to randomization.

Exclusion Criteria:

Stage III or IV breast cancer.
Surgical margins that cannot be microscopically assessed.
Extensive intraductal component (EIC).
Paget's disease or pathological skin involvement.
Synchronous or previous breast cancer.
Prior malignancy (< 5 years prior to enrollment in study) except non-melanoma skin cancer or cervical carcinoma FIGO 0 and I if patient is continuously disease-free.
Pregnant or lactating women.
Collagen vascular disease.
The presence of congenital diseases with increased radiation sensitivity, for example Ataxia telangiectatica or similar.
Psychiatric disorders.
Patient with breast deemed technically unsatisfactory for brachytherapy.

Sex/Gender

Sexes Eligible for Study:

Female

Ages

40 Years and older (Adult, Senior)

Accepts Healthy Volunteers

Contacts ^ICMJE

Contact information is only displayed when the study is recruiting subjects

Listed Location Countries ^ICMJE

Austria, Germany, Hungary, Poland, Spain

Removed Location Countries

Administrative Information

NCT Number ^ICMJE

NCT00402519

Other Study ID Numbers ^ICMJE

GEC-ESTRO APBI Trial

Has Data Monitoring Committee

U.S. FDA-regulated Product

Not Provided

IPD Sharing Statement

Plan to Share IPD:

Undecided

Responsible Party

University of Erlangen-Nürnberg Medical School

Study Sponsor ^ICMJE

University of Erlangen-Nürnberg Medical School

Collaborators ^ICMJE

Not Provided

Investigators ^ICMJE

Study Chair:	Vratislav Strnad, MD	University Hospital Erlangen, Germany
Study Chair:	Csaba Polgár, MD	National Institute of Oncology Budapest, Hungary
Study Director:	Oliver J Ott, MD	University Hospital Erlangen, Germany

PRS Account

University of Erlangen-Nürnberg Medical School

Verification Date

May 2016

^ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP

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