Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis

NCT04414202 | Active Not Recruiting Results

• 1 other identifier: 2009/OBS-01
• Study Type: observational
• Target: 519
• Locations: 1 country
• Sites: 1

Brief Summary

Due to screening, T1N0 early-stage breast cancer now accounts for more than 50% of the tumors diagnosed in France. The prognosis of these tumors is good, even excellent in women ≥ 65 years of age, with specific survival of 98% at 5 years. The treatment of these tumors combines breast-conserving surgery and external whole breast irradiation for 6.5 weeks. A true de-escalation of treatment is taking place with these tumors, both surgically and medically. Surgery therefore now prefers breast-conserving methods in combination with exeresis of the sentinel lymph node only. In the same way, in many international studies, radiotherapy has been evaluating the possibility of reducing both:

• the irradiation volume at the excision site (partial irradiation)
• the duration of this irradiation (accelerated radiotherapy) Between 2004 and 2007, the CRLC \[Regional Anti-Cancer Center\] evaluated the feasibility and the oncological results of intra-operative partial irradiation via a phase II study in women 65 years of age and older with T1N0M0 hormone-sensitive tumors with a good prognosis. From 2010 to 2013, the ICM carried out an observational study of these tumors with an excellent prognosis. In July 2009, the American Society for Radiation Oncology (ASTRO) published a consensus statement with specific recommendations and indications for accelerated partial breast irradiation (APBI). This APBI technique has been developing in France over the past 5 years within the framework of clinical studies and in compliance with the 2012 recommendations of the French National Cancer Institute. This APBI can be given by 3D external radiotherapy or, as in this study, by intra-operative radiotherapy (IORT) in order to obtain optimal precision and spare as much of the surrounding healthy tissue as possible. The Investigator therefore propose a cohort study to prospectively analyze the results of this technique applied to the indications strictly defined by the ASTRO.

Conditions

Invasive Breast Cancer; Breast-conserving Surgery

Keywords

breast cancer; good prognosis; surgery; intra-operative partial irradiation

Outcome Measures

Primary Outcomes (1)

• Number of Patient With a Local Intra-mammary Relapse

  The local relapse rate, defined as the number of intramammary relapses in the treated breast (regardless of quadrant and including skin), appreciated at 5 years and 10 years. It will be assessed according to the recommendations applied to the Centre

  post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)

Secondary Outcomes (4)

• Cosmetic Results

  post surgery : 3 weeks, 6 months and 12 months

• Patients' Satisfaction Towards the Treatment

  post surgery : 3 weeks, 6 months and 12 months

• Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients

  post surgery : 3 weeks, 6 months and 12 months

• Overall Survival

  from baseline to 10 years after treatment

Study Arms (1)

1 GROUP

Patient with an Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery. The treatment combines extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor Follow up after this treatment will scheduled 10 years

Procedure: tumorectomy with axillary dissection (sentinel lymph node); Radiation: per-operative partial irradiation

Interventions

tumorectomy with axillary dissection (sentinel lymph node) PROCEDURE

All patients will have local excision of the primary tumor following appropriate clinical work-up. Surgery will be done according to usual local practice with a complete excision of the tumor. The aim of the local excision should be to achieve a minimum free margin of 2 mm whilst maintaining a good cosmetic outcome.

1 GROUP

per-operative partial irradiation RADIATION

20 Gy of per-operative partial irradiation at the tumor site during the surgery

1 GROUP

Eligibility Criteria

• Age: 60 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery

You may qualify if:

• Women 60 years of age or older,
• Histologically proven invasive ductal breast cancer or of a histologically favorable sub-type (mucinous, tubular or colloid),
• Unifocal tumor,
• T1 (diameter ≤ 20 mm),
• N0 (pN0 or pNi+),
• M0,
• Gland exeresis margins ≥ 2 mm,
• Estrogen receptor positive,
• Information and non-opposition of the patient.

You may not qualify if:

• Inflammatory breast cancer,
• Associated peri-tumoral lymphatic emboli
• Associated extensive intra-ductal component
• Invasive lobular carcinoma
• Pure ductal carcinoma in situ,
• Sarcoma or lymphoma-type non-epithelial tumor
• Synchronous bilateral breast cancer,
• Any prior neo-adjuvant treatment: radiotherapy, chemotherapy, hormone therapy

Sponsors & Collaborators

• Institut du Cancer de Montpellier - Val d'Aurelle: lead

Study Sites (1)

Icm Val D'Aurelle

Montpellier, Herault, 34398, France

Location

Related Publications (12)

• Grosclaude P, Colonna M, Hedelin G, Tretarre B, Arveux P, Lesec'h JM, Raverdy N, Sauvage-Machelard M. Survival of women with breast cancer in france: variation with age, stage and treatment. Breast Cancer Res Treat. 2001 Nov;70(2):137-43. doi: 10.1023/a:1012974728007.

  PMID: 11768604 BACKGROUND

• van Dongen JA, Voogd AC, Fentiman IS, Legrand C, Sylvester RJ, Tong D, van der Schueren E, Helle PA, van Zijl K, Bartelink H. Long-term results of a randomized trial comparing breast-conserving therapy with mastectomy: European Organization for Research and Treatment of Cancer 10801 trial. J Natl Cancer Inst. 2000 Jul 19;92(14):1143-50. doi: 10.1093/jnci/92.14.1143.

  PMID: 10904087 BACKGROUND

• Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989.

  PMID: 12393819 BACKGROUND

• Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7.

  PMID: 16360786 BACKGROUND

• Bartelink H, Horiot JC, Poortmans PM, Struikmans H, Van den Bogaert W, Fourquet A, Jager JJ, Hoogenraad WJ, Oei SB, Warlam-Rodenhuis CC, Pierart M, Collette L. Impact of a higher radiation dose on local control and survival in breast-conserving therapy of early breast cancer: 10-year results of the randomized boost versus no boost EORTC 22881-10882 trial. J Clin Oncol. 2007 Aug 1;25(22):3259-65. doi: 10.1200/JCO.2007.11.4991. Epub 2007 Jun 18.

  PMID: 17577015 BACKGROUND

• Dubois JB, Hay M, Gely S, Saint-Aubert B, Rouanet P, Pujol H. IORT in breast carcinomas. Front Radiat Ther Oncol. 1997;31:131-7. doi: 10.1159/000061160. No abstract available.

  PMID: 9263806 BACKGROUND

• Lemanski C, Azria D, Thezenas S, Gutowski M, Saint-Aubert B, Rouanet P, Fenoglietto P, Ailleres N, Dubois JB. Intraoperative radiotherapy given as a boost for early breast cancer: long-term clinical and cosmetic results. Int J Radiat Oncol Biol Phys. 2006 Apr 1;64(5):1410-5. doi: 10.1016/j.ijrobp.2005.10.025. Epub 2006 Jan 25.

  PMID: 16442241 BACKGROUND

• Lemanski C, Azria D, Gourgon-Bourgade S, Gutowski M, Rouanet P, Saint-Aubert B, Ailleres N, Fenoglietto P, Dubois JB. Intraoperative radiotherapy in early-stage breast cancer: results of the montpellier phase II trial. Int J Radiat Oncol Biol Phys. 2010 Mar 1;76(3):698-703. doi: 10.1016/j.ijrobp.2009.02.039. Epub 2009 May 23.

  PMID: 19467579 BACKGROUND

• Smith BD, Arthur DW, Buchholz TA, Haffty BG, Hahn CA, Hardenbergh PH, Julian TB, Marks LB, Todor DA, Vicini FA, Whelan TJ, White J, Wo JY, Harris JR. Accelerated partial breast irradiation consensus statement from the American Society for Radiation Oncology (ASTRO). J Am Coll Surg. 2009 Aug;209(2):269-77. doi: 10.1016/j.jamcollsurg.2009.02.066. Epub 2009 Apr 24. No abstract available.

  PMID: 19632605 BACKGROUND

• Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152.

  PMID: 12393820 BACKGROUND

• Vlastos G, Mirza NQ, Meric F, Hunt KK, Kuerer HM, Ames FC, Ross MI, Buchholz TA, Hortobagyi GN, Singletary SE. Breast conservation therapy as a treatment option for the elderly. The M. D. Anderson experience. Cancer. 2001 Sep 1;92(5):1092-100. doi: 10.1002/1097-0142(20010901)92:53.0.co;2-p.

  PMID: 11571720 BACKGROUND

• Vinh-Hung V, Verschraegen C. Breast-conserving surgery with or without radiotherapy: pooled-analysis for risks of ipsilateral breast tumor recurrence and mortality. J Natl Cancer Inst. 2004 Jan 21;96(2):115-21. doi: 10.1093/jnci/djh013.

  PMID: 14734701 BACKGROUND

Related Links

• Institut de Veille Sanitaire- Institut National du Cancer

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Results Point of Contact

• Title: Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation
• Organization: INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier

drci-icm105@icm.unicancer.fr

0467613102

Study Officials

• LEMANSKI Claire, DR

  ICM Val d'Aurelle DRCI

  STUDY CHAIR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 10 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 19, 2020
• First Posted: June 4, 2020
• Study Start: December 15, 2009
• Primary Completion: October 16, 2023
• Study Completion (Estimated): December 1, 2030
• Last Updated: May 1, 2026
• Results First Posted: April 2, 2025

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

FR (1)