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Breast CancerPhase 3NCT00002851

Lymph Node Radiation Therapy in Patients With Stage I, Stage II, or Stage III Breast Cancer That Has Been Surgically Removed

A Phase 3 study testing adjuvant therapy, low-LET electron therapy and low-LET photon therapy in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 48 sites in 14 countries.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery. PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed. Read more about this study

Who is it for?
Ages Up to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
adjuvant therapy, low-LET electron therapy and low-LET photon therapy
Type of treatment
Surgery or procedure
How many people
4,000 participants
Where
48 sitesin 14 countries
Study dates
Jul 1996to not given
Phase
Phase 3
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 75 years
  • Women only
  • No healthy volunteers
  • Child, Adult, Older adult

DISEASE CHARACTERISTICS:

  • Histologically confirmed unilateral adenocarcinoma of the breast
  • Stage I/II/III (Tx, T0-3, N0-2) disease in one of the following categories or multifocal tumors if one of the foci is in agreement with the following:
  • Centrally or medially located with any lymph node status
  • Central location defined as underlying the areola
  • Medial location defined as at least partial involvement of upper or lower medial quadrant of breast
  • Externally located with axillary node involvement
  • Prior mastectomy or breast-conserving surgery and axillary dissection required
  • Sentinel node procedure as axillary intervention without further axillary surgery is allowed
  • No prior internal mammary chain dissection
  • No upper inner lesion treated with breast-conserving surgery that precludes sparing of internal mammary lymph node chain from radiotherapy volume
  • Decision at radiation oncologist's discretion
  • Hormone receptor status:
  • Not specified

PATIENT CHARACTERISTICS:

Age:

  • 75 and under

Sex:

  • Female

Menopausal status:

  • Not specified

Performance status:

  • Not specified

Hematopoietic:

  • Not specified

Hepatic:

  • Not specified

Renal:

  • Not specified

Cardiovascular:

  • No prior cardiac disease

Other:

  • No prior malignancy except adequately treated nonmelanomatous skin cancer or carcinoma in situ of the cervix

PRIOR CONCURRENT THERAPY:

Biologic therapy:

  • Not specified

Chemotherapy:

  • Not specified

Endocrine therapy:

  • Not specified

Radiotherapy:

  • Not specified

Surgery:

  • See Disease Characteristics

Other:

  • Concurrent enrollment in other randomized trials allowed

Trial locations and contacts

48 sites in 14 countries.

48 sites in 14 countries

France11 sites

  • CHR de Besancon - Hopital Jean Minjoz

    Besançon, 25030

  • Institut Bergonie

    Bordeaux, 33076

  • Centre de Lutte Contre le Cancer Georges-Francois Leclerc

    Dijon, 21079

  • CHU de Grenoble - Hopital de la Tronche

    Grenoble, 38043

  • Service Cancerologie Polyclinique Clairval

    Marseille, 13009

  • Centre Antoine Lacassagne

    Nice, 06189

  • Centre Eugene Marquis

    Rennes, 35042

  • Centre Hospitalier Universitaire Henri Mondor

    Strasbourg, 67085

  • Centre Leon Berard

    Strasbourg, 67085

  • Centre Paul Strauss

    Strasbourg, 67085

  • Institut Gustave Roussy

    Strasbourg, 67085

Other trials in France

Netherlands9 sites

  • Medisch Centrum Haaglanden

    's-Gravenhage (Den Haag, the Hague), 2501 CK

  • Academisch Medisch Centrum

    Amsterdam, 1105 AZ

  • Streekziekenhuis Gooi-Noord

    Blaricum, 1261 AN

  • Radiotherapeutisch Instituut-(Riso)

    Deventer, 7400 AC

  • Medisch Spectrum Twente

    Enschede, 7500 KA

  • Academisch Ziekenhuis Groningen

    Groningen, 9713 GZ

  • Radiotherapeutisch Instituut Limburg-Maastricht

    Maastricht, NL-6229 ET

  • Dr. Bernard Verbeeten Instituut

    Tilburg, 5042 SB

  • Academisch Ziekenhuis Utrecht

    Utrecht, 3584 CX

Other trials in Netherlands

Germany7 sites

  • Charite - Campus Charite Mitte

    Berlin, D-10117

  • Robert Roessle Comprehensive Cancer Center at University of Berlin - Charite Campus Buch

    Berlin, D-13122

  • Klinik I fuer Innere Medizin

    Cologne, D-50924

  • University of Erlangen-Nuremberg

    Erlangen, DOH-91054

  • Universitaetsklinikum Essen

    Essen, D-45122

  • Universitaetsklinikum Goettingen

    Göttingen, D-37075

  • Universitaetsklinikum Tuebingen

    Tübingen, D-72076

Other trials in Germany

Belgium6 sites

  • Ziekenhuis Network Antwerpen Middelheim

    Antwerp, 2020

  • Cliniques Universitaires Saint-Luc

    Brussels, 1200

  • Hopital de Jolimont

    Haine-Saint-Paul, 7100

  • Cazk Groeninghe - Campus Maria's Voorzienigheid

    Kortrijk, B-8500

  • U.Z. Gasthuisberg

    Leuven, B-3000

  • Algemeen Ziekenhuis Sint-Augustinus

    Wilrijk, 2610

Other trials in Belgium

Switzerland3 sites

  • Hopital Cantonal Universitaire de Geneve

    Geneva, CH-1211

  • Centre Hospitalier Universitaire Vaudois

    Lausanne, CH-1011

  • UniversitaetsSpital

    Zurich, CH-8091

Other trials in Switzerland

Chile2 sites

  • Instituto de Radiomedicina

    Santiago, 10

  • Clinica Alemana

    Santiago, 5951

Other trials in Chile

Israel2 sites

  • Rambam Medical Center

    Haifa, 31096

  • Chaim Sheba Medical Center

    Ramat Gan, 52621

Other trials in Israel

Italy2 sites

  • Ospedale Sant Anna

    Como, 22100

  • Istituto Nazionale per la Ricerca sul Cancro

    Genoa (Genova), 16132

Other trials in Italy

Bosnia and Herzegovina1 site

  • Institute of Oncology - Clinical Center University of Sarajevo

    Sarajevo, 71000

Other trials in Bosnia and Herzegovina

Poland1 site

  • Medical University of Gdansk

    Gdansk, 80-211

Other trials in Poland

Portugal1 site

  • Instituto Portugues de Oncologia Centro do Porto, SA

    Porto, 4200-072

Other trials in Portugal

Spain1 site

  • Institut Catala D'Oncologia

    Barcelona, 08907

Other trials in Spain

Turkey (Türkiye)1 site

  • Istanbul University-Institute of Oncology

    Istanbul, 34390

Other trials in Turkey (Türkiye)

United Kingdom1 site

  • Nottingham City Hospital NHS Trust

    Nottingham, England, NG5 1PB

Other trials in United Kingdom

About this study

Official title: PHASE III RANDOMISED TRIAL INVESTIGATING THE ROLE OF INTERNAL MAMMARY AND MEDIAL SUPRACLAVICULAR (IM-MS) LYMPH NODE CHAIN IRRADIATION IN STAGE I-III BREAST CANCER

RATIONALE: Radiation therapy may kill any tumor cells remaining after surgery.

PURPOSE: This randomized phase III trial is studying radiation therapy to see how well it works compared to no further therapy in treating women with stage I, stage II, or stage III breast cancer that has been surgically removed.

Read the detailed description

OBJECTIVES:

  • Compare the effect of irradiation of the homolateral internal mammary and medial supraclavicular lymph node chains vs no further therapy on survival, disease-free survival, metastasis-free survival, and cause of death in women with resected stage I/II/III breast cancer.

OUTLINE: This is a randomized, multicenter study. Patients are stratified by participating institution, tumor location, type of prior breast surgery, pathologic T and N stage, menopausal status, and time sequence of radiotherapy and adjuvant chemotherapy. Patients are randomized to 1 of 2 arms.

  • Arm I: Patients receive no nodal irradiation.
  • Arm II: Patients receive irradiation of the internal mammary and medial supraclavicular lymph node chains delivered at 1 fraction per day, 5 sessions per week, for a total of 25 fractions over 5 weeks. Radiotherapy must begin no later than 8 weeks after surgery. If adjuvant chemotherapy is given, radiotherapy begins within 6 weeks after the last course of chemotherapy and within 8 months after surgery.

Patients are followed at least yearly after randomization for up to 20 years.

PROJECTED ACCRUAL: A total of 4,000 patients will be accrued for this study within 4 years.

Conditions
Breast Cancer
Being tested
adjuvant therapy, low-LET electron therapy, low-LET photon therapy
Keywords
stage I breast cancer, stage II breast cancer, stage IIIA breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • adjuvant therapyProcedure or surgery

  • low-LET electron therapyRadiation

  • low-LET photon therapyRadiation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted27 Jan 2003 (estimated)
  2. Study startJul 1996

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 3
Primary purpose
Treatment
Allocation
Randomised
Enrolment
4,000 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00002851
Sponsor's protocol ID
CDR0000065094
Other IDs
EORTC-10925, EORTC-22922
Status last verified
Dec 2004
First submitted
1 Nov 1999
Last updated
29 Jan 2010
Results posted
No

Publications

  • Matzinger O, Heimsoth I, Poortmans P, Collette L, Struikmans H, Van Den Bogaert W, Fourquet A, Bartelink H, Ataman F, Gulyban A, Pierart M, Van Tienhoven G; EORTC Radiation Oncology & Breast Cancer Groups. Toxicity at three years with and without irradiation of the internal mammary and medial supraclavicular lymph node chain in stage I to III breast cancer (EORTC trial 22922/10925). Acta Oncol. 2010;49(1):24-34. doi: 10.3109/02841860903352959.

    PubMed 20100142

  • Musat E, Poortmans P, Van den Bogaert W, Struikmans H, Fourquet A, Bartelink H, Kirkove C, Budach V, Pierart M, Collette L. Quality assurance in breast cancer: EORTC experiences in the phase III trial on irradiation of the internal mammary nodes. Eur J Cancer. 2007 Mar;43(4):718-24. doi: 10.1016/j.ejca.2006.11.015. Epub 2007 Jan 19.

    PubMed 17240136

  • Poortmans P, Kouloulias V, van Tienhoven G, Collette L, Struikmans H, Venselaar JL, Van den Bogaert W, Davis JB, Lambin P; EORTC Radiation Oncology and Breast Cancer Groups. Quality assurance in the EORTC randomized trial 22922/10925 investigating the role of irradiation of the internal mammary and medial supraclavicular lymph node chain works. Strahlenther Onkol. 2006 Oct;182(10):576-82. doi: 10.1007/s00066-006-1629-2.

    PubMed 17013570

  • Poortmans P, Kouloulias VE, Venselaar JL, Struikmans H, Davis JB, Huyskens D, van Tienhoven G, Hurkmans C, Mijnheer B, Van den Bogaert W. Quality assurance of EORTC trial 22922/10925 investigating the role of internal mammary--medial supraclavicular irradiation in stage I-III breast cancer: the individual case review. Eur J Cancer. 2003 Sep;39(14):2035-42. doi: 10.1016/s0959-8049(03)00455-6.

    PubMed 12957458

  • Poortmans PM, Venselaar JL, Struikmans H, Hurkmans CW, Davis JB, Huyskens D, van Tienhoven G, Vlaun V, Lagendijk JJ, Mijnheer BJ, De Winter KA, Van der Hulst MH, Van den Bogaert WF. The potential impact of treatment variations on the results of radiotherapy of the internal mammary lymph node chain: a quality-assurance report on the dummy run of EORTC Phase III randomized trial 22922/10925 in Stage I--III breast cancer(1). Int J Radiat Oncol Biol Phys. 2001 Apr 1;49(5):1399-408. doi: 10.1016/s0360-3016(00)01549-2.

    PubMed 11286848

  • Poortmans P, Van Den Bogaert W, Venselaar J, et al.: Quality assurance in EORTC trial 22922/10925 concerning internal mammary chain (IMC) irradiation: the dummy run. Radiother Oncol 48(suppl 1): A735, s186, 1998.

  • Poortmans P, Van Den Bogaert W, Venselaar J, et al.: EORTC randomized phase III trials 22922/10925 investigating the role of internal mammary chain (IMC) irradiation in stage I-II breast cancer: a quality assurance report on the dummy run. Eur J Cancer 34(suppl 5): A257, s58, 1998.

  • Kaidar-Person O, Weltens CG, Fortpied C, Scheijmans LJEE, Kirkove CY, Budach V, Peignaux-Casasnovas K, Valli M, Peters M, van der Leij F, Rivera S, Weidner N, van den Bongard DHJG, Linsenmeier C, Abdah-Bortnyak R, Hosni S, Koiter E, Engelen AM, Baten A, Champezou L, Fourquet A, Bartelink HGMM, Struikmans H, Poortmans PMP; EORTC Radiation Oncology and Breast Cancer Groups. Internal mammary chain and medial supraclavicular lymph node irradiation in stage I-III breast cancer (EORTC trial 22922/10925): an unplanned subset analysis of 20-year outcomes in patients with node-negative breast cancer. Lancet Oncol. 2026 Jul;27(7):817-829. doi: 10.1016/S1470-2045(26)00233-0.

    PubMed 42372743

  • Siman-Tov M, Ostrovski A, Mast M, Struikmans H, Bogers L, Fortpied C, Hol S, Petoukhova A, van Egmond J, Poortmans P, Kaidar-Person O. Dosimetric Analyses of the Three Radiation Techniques Used in the EORTC 22922/10925 IM-MS Breast Cancer Trial. Clin Oncol (R Coll Radiol). 2024 Nov;36(11):690-700. doi: 10.1016/j.clon.2024.08.012. Epub 2024 Aug 24.

    PubMed 39261237

  • Kaidar-Person O, Fortpied C, Hol S, Weltens C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, Weidner N, Guckenberger M, Koiter E, Fourquet A, Bartelink H, Struikmans H, Poortmans P; EORTC Radiation Oncology and Breast Cancer Groups. The association of internal mammary and medial supraclavicular lymph node radiation technique with clinical outcomes: Results from the EORTC 22922/10925 randomised trial. Radiother Oncol. 2022 Jul;172:99-110. doi: 10.1016/j.radonc.2022.05.006. Epub 2022 May 12.

    PubMed 35568284

  • Poortmans PM, Struikmans H, De Brouwer P, Weltens C, Fortpied C, Kirkove C, Budach V, Peignaux-Casasnovas K, van der Leij F, Vonk E, Valli M, vanTienhoven G, Weidner N, Noel G, Guckenberger M, Koiter E, vanLimbergen E, Engelen A, Fourquet A, Bartelink H; EORTC Radiation Oncology and Breast Cancer Groups. Side Effects 15 Years After Lymph Node Irradiation in Breast Cancer: Randomized EORTC Trial 22922/10925. J Natl Cancer Inst. 2021 Oct 1;113(10):1360-1368. doi: 10.1093/jnci/djab113.

    PubMed 34320651

  • Poortmans PM, Weltens C, Fortpied C, Kirkove C, Peignaux-Casasnovas K, Budach V, van der Leij F, Vonk E, Weidner N, Rivera S, van Tienhoven G, Fourquet A, Noel G, Valli M, Guckenberger M, Koiter E, Racadot S, Abdah-Bortnyak R, Van Limbergen EF, Engelen A, De Brouwer P, Struikmans H, Bartelink H; European Organisation for Research and Treatment of Cancer Radiation Oncology and Breast Cancer Groups. Internal mammary and medial supraclavicular lymph node chain irradiation in stage I-III breast cancer (EORTC 22922/10925): 15-year results of a randomised, phase 3 trial. Lancet Oncol. 2020 Dec;21(12):1602-1610. doi: 10.1016/S1470-2045(20)30472-1. Epub 2020 Nov 2.

    PubMed 33152277

  • Poortmans PM, Collette S, Kirkove C, Van Limbergen E, Budach V, Struikmans H, Collette L, Fourquet A, Maingon P, Valli M, De Winter K, Marnitz S, Barillot I, Scandolaro L, Vonk E, Rodenhuis C, Marsiglia H, Weidner N, van Tienhoven G, Glanzmann C, Kuten A, Arriagada R, Bartelink H, Van den Bogaert W; EORTC Radiation Oncology and Breast Cancer Groups. Internal Mammary and Medial Supraclavicular Irradiation in Breast Cancer. N Engl J Med. 2015 Jul 23;373(4):317-27. doi: 10.1056/NEJMoa1415369.

    PubMed 26200978

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing adjuvant therapy, low-LET electron therapy and low-LET photon therapy in people with Breast Cancer, run by European Organisation for Research and Treatment of Cancer - EORTC at 48 sites in 14 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: status not confirmed, as of the sponsor's last update on 29 Jan 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 48 sites in France, Netherlands, Germany, Belgium, Switzerland and 9 more countries. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00002851, which also lists 13 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 29 Jan 2010; AzTrials last refreshed its copy on 4 Nov 2026.

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