search
Back to results

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

Primary Purpose

Breast Cancer

Status
Unknown status
Phase
Phase 3
Locations
International
Study Type
Interventional
Intervention
Accelerated partial breast irradiation
External beam whole breast irradiation
Sponsored by
University of Erlangen-Nürnberg Medical School
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Breast Cancer focused on measuring accelerated partial breast irradiation, multicatheter brachytherapy, high dose rate brachytherapy, pulsed dose rate brachytherapy

Eligibility Criteria

40 Years - undefined (Adult, Older Adult)FemaleDoes not accept healthy volunteers

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.

Sites / Locations

  • University Hospital AKH Wien, Department of Radiotherapy and Radiobiology
  • University Hospital Erlangen, Department of Radiation Oncology
  • University Hospital Kiel, Department of Radiation Oncology
  • University Hospital Leipzig, Department of Radiation Oncology
  • University Hospital Lübeck, Department of Radiation Oncology
  • Hospital Barmherzige Brüder, Department of Radiation Oncology
  • University Hospital Rostock, Department of Radiation Oncology
  • National Institute of Oncology, Department of Radiation Oncology
  • Kierownik Zakladu Brachyterapii, Cetrum Onkologii
  • Catalan Institut of Oncology, Department of Radiation Oncology
  • Valencian Institut of Oncology, Department of Radiation Oncology

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

APBI

EBRT

Arm Description

Accelerated Partial Breast Irradiation with multicatheter brachytherapy

Standard External Beam Whole Breast Irradiation

Outcomes

Primary Outcome Measures

Local control

Secondary Outcome Measures

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

Full Information

First Posted
November 21, 2006
Last Updated
May 12, 2016
Sponsor
University of Erlangen-Nürnberg Medical School
search

1. Study Identification

Unique Protocol Identification Number
NCT00402519
Brief Title
APBI Versus EBRT Therapy After Breast Conserving Surgery for Low-risk Breast Cancer
Official Title
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
Study Type
Interventional

2. Study Status

Record Verification Date
May 2016
Overall Recruitment Status
Unknown status
Study Start Date
November 2004 (undefined)
Primary Completion Date
November 2009 (Actual)
Study Completion Date
November 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Erlangen-Nürnberg Medical School

4. Oversight

Data Monitoring Committee
No

5. Study Description

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
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Cancer
Keywords
accelerated partial breast irradiation, multicatheter brachytherapy, high dose rate brachytherapy, pulsed dose rate brachytherapy

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 3
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
1300 (Actual)

8. Arms, Groups, and Interventions

Arm Title
APBI
Arm Type
Experimental
Arm Description
Accelerated Partial Breast Irradiation with multicatheter brachytherapy
Arm Title
EBRT
Arm Type
Active Comparator
Arm Description
Standard External Beam Whole Breast Irradiation
Intervention Type
Radiation
Intervention Name(s)
Accelerated partial breast irradiation
Intervention Description
APBI with PDR and HDR brachytherapy
Intervention Type
Radiation
Intervention Name(s)
External beam whole breast irradiation
Intervention Description
Standard Whole breast irradiation
Primary Outcome Measure Information:
Title
Local control
Time Frame
5-years, 10 ten-years
Secondary Outcome Measure Information:
Title
Incidence and severity of acute and late side effects
Time Frame
5-years
Title
Differences in cosmetic results
Time Frame
5-years
Title
Distant metastases free survival
Time Frame
5-years
Title
Survival rates (Overall Survival, Disease-free Survival)
Time Frame
5-years
Title
Contralateral breast cancer rate
Time Frame
5-years
Title
Quality-of-Life
Time Frame
5-years

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
40 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Vratislav Strnad, MD
Organizational Affiliation
University Hospital Erlangen, Germany
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Csaba Polgár, MD
Organizational Affiliation
National Institute of Oncology Budapest, Hungary
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Oliver J Ott, MD
Organizational Affiliation
University Hospital Erlangen, Germany
Official's Role
Study Director
Facility Information:
Facility Name
University Hospital AKH Wien, Department of Radiotherapy and Radiobiology
City
Vienna
Country
Austria
Facility Name
University Hospital Erlangen, Department of Radiation Oncology
City
Erlangen
ZIP/Postal Code
91054
Country
Germany
Facility Name
University Hospital Kiel, Department of Radiation Oncology
City
Kiel
Country
Germany
Facility Name
University Hospital Leipzig, Department of Radiation Oncology
City
Leipzig
Country
Germany
Facility Name
University Hospital Lübeck, Department of Radiation Oncology
City
Lübeck
Country
Germany
Facility Name
Hospital Barmherzige Brüder, Department of Radiation Oncology
City
Regensburg
Country
Germany
Facility Name
University Hospital Rostock, Department of Radiation Oncology
City
Rostock
Country
Germany
Facility Name
National Institute of Oncology, Department of Radiation Oncology
City
Budapest
Country
Hungary
Facility Name
Kierownik Zakladu Brachyterapii, Cetrum Onkologii
City
Warszawa
Country
Poland
Facility Name
Catalan Institut of Oncology, Department of Radiation Oncology
City
Barcelona
ZIP/Postal Code
08907
Country
Spain
Facility Name
Valencian Institut of Oncology, Department of Radiation Oncology
City
Valencia
ZIP/Postal Code
46009
Country
Spain

12. IPD Sharing Statement

Plan to Share IPD
Undecided
Citations:
PubMed Identifier
29695348
Citation
Schafer R, Strnad V, Polgar C, Uter W, Hildebrandt G, Ott OJ, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Kovacs G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Gall C, Polat B; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). Quality-of-life results for accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation in early breast cancer after breast-conserving surgery (GEC-ESTRO): 5-year results of a randomised, phase 3 trial. Lancet Oncol. 2018 Jun;19(6):834-844. doi: 10.1016/S1470-2045(18)30195-5. Epub 2018 Apr 22.
Results Reference
derived
PubMed Identifier
28094198
Citation
Polgar C, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Fietkau R, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Uter W, Strnad V; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). Late side-effects and cosmetic results of accelerated partial breast irradiation with interstitial brachytherapy versus whole-breast irradiation after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: 5-year results of a randomised, controlled, phase 3 trial. Lancet Oncol. 2017 Feb;18(2):259-268. doi: 10.1016/S1470-2045(17)30011-6. Epub 2017 Jan 14.
Results Reference
derived
PubMed Identifier
27422584
Citation
Ott OJ, Strnad V, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Miguelez CG, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Kortmann RD, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). GEC-ESTRO multicenter phase 3-trial: Accelerated partial breast irradiation with interstitial multicatheter brachytherapy versus external beam whole breast irradiation: Early toxicity and patient compliance. Radiother Oncol. 2016 Jul;120(1):119-23. doi: 10.1016/j.radonc.2016.06.019. Epub 2016 Jul 12.
Results Reference
derived
PubMed Identifier
26494415
Citation
Strnad V, Ott OJ, Hildebrandt G, Kauer-Dorner D, Knauerhase H, Major T, Lyczek J, Guinot JL, Dunst J, Gutierrez Miguelez C, Slampa P, Allgauer M, Lossl K, Polat B, Kovacs G, Fischedick AR, Wendt TG, Fietkau R, Hindemith M, Resch A, Kulik A, Arribas L, Niehoff P, Guedea F, Schlamann A, Potter R, Gall C, Malzer M, Uter W, Polgar C; Groupe Europeen de Curietherapie of European Society for Radiotherapy and Oncology (GEC-ESTRO). 5-year results of accelerated partial breast irradiation using sole interstitial multicatheter brachytherapy versus whole-breast irradiation with boost after breast-conserving surgery for low-risk invasive and in-situ carcinoma of the female breast: a randomised, phase 3, non-inferiority trial. Lancet. 2016 Jan 16;387(10015):229-38. doi: 10.1016/S0140-6736(15)00471-7. Epub 2015 Oct 19.
Results Reference
derived
Links:
URL
http://www.apbi.uni-erlangen.de
Description
Trial Homepage with a short version of the protocol

Learn more about this trial

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

We'll reach out to this number within 24 hrs