Invasive Breast CancerINTRA-OBSNCT04414202
Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis
An observational study of Invasive Breast Cancer and Breast-conserving Surgery, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 60 years and older, women only
- Conditions the study is for
- Invasive Breast Cancer, Breast-conserving Surgery
- What is being tested?
- tumorectomy with axillary dissection (sentinel lymph node) and per-operative partial irradiation
- Type of treatment
- Surgery or procedure
- How many people
- 519 participants
- Where
- 1 siteFrance
- Study dates
- 15 Dec 2009to Dec 2030
- How long will I take part?
- 10 Years
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 60 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery
Who may be able to join
- 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,
Show all 9Show fewer
- Gland exeresis margins ≥ 2 mm,
- Estrogen receptor positive,
- Information and non-opposition of the patient.
Who cannot join
- -. 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
Trial locations and contacts
1 site in 1 country.
About this study
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.
Read more
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.
Read the detailed description
after registration, particpants have as treatment "combination extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor site.
follow up after this treatment during 5 years
- Conditions
- Invasive Breast Cancer, Breast-conserving Surgery
- Being tested
- tumorectomy with axillary dissection (sentinel lymph node), per-operative partial irradiation
- Keywords
- breast cancer, good prognosis, surgery, intra-operative partial irradiation
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tumorectomy with axillary dissection (sentinel lymph node)Procedure or surgery
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.
per-operative partial irradiationRadiation
20 Gy of per-operative partial irradiation at the tumor site during the surgery
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Procedure: tumorectomy with axillary dissection (sentinel lymph node); Radiation: per-operative partial irradiation |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
Secondary outcomes (4)
Cosmetic Results
Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result")
Measured: post surgery : 3 weeks, 6 months and 12 months
Patients' Satisfaction Towards the Treatment
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
Measured: post surgery : 3 weeks, 6 months and 12 months
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
Assessment of the impact of this accelerated treatment on maintaining the autonomy of the subject by the use of geriatric scale (ADL (Activities of Daily Living), IADL (instrumental Activities of Daily Living)). (scale from 0 "no autonomy" to 10 "good autonomy")
Measured: post surgery : 3 weeks, 6 months and 12 months
Overall Survival
rate of death
Measured: from baseline to 10 years after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2020
- Study start15 Dec 2009
- Primary completion16 Oct 2023
- Study completionDec 2030 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for Invasive Breast CancerStudies of the same condition, open and under way.
- More trials run by Institut du Cancer de Montpellier - Val d'AurelleThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 519 participants (actual)
- Target duration
- 10 Years
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- LEMANSKI Claire, DR, Study chair, ICM Val d'Aurelle DRCI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04414202
- Sponsor's protocol ID
- 2009/OBS-01
- Acronym
- INTRA-OBS
- Status last verified
- Jun 2026
- First submitted
- 19 May 2020
- Last updated
- 23 Jun 2026
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
Publications
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.
PubMed 11768604van 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.
PubMed 10904087Veronesi 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.
PubMed 12393819Clarke 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.
PubMed 16360786Bartelink 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.
PubMed 17577015Dubois 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.
PubMed 9263806Lemanski 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.
PubMed 16442241Lemanski 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.
PubMed 19467579Smith 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.
PubMed 19632605Fisher 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.
PubMed 12393820Vlastos 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.
PubMed 11571720Vinh-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.
PubMed 14734701
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis
- ClinicalTrials.gov ID
- NCT04414202
- Acronym / sponsor ID
- INTRA-OBS / 2009/OBS-01
- Conditions
- Invasive Breast Cancer, Breast-conserving Surgery
- Keywords
- breast cancer, good prognosis, surgery, intra-operative partial irradiation
- Study type
- Observational
- Recruitment status
- Active, not recruiting
- Enrolment
- 519 participants (actual)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 15 Dec 2009 (actual)
- Primary completion
- 16 Oct 2023 (actual)
- Study completion
- Dec 2030 (estimated)
- First posted
- 4 Jun 2020 (actual)
- Results
- Posted 2 Apr 2025
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
after registration, particpants have as treatment "combination extended tumorectomy with axillary dissection (sentinel lymph node) in addition to 20 Gy of per-operative partial irradiation at the tumor site.
follow up after this treatment during 5 years
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Target follow-up
- 10 Years
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| 1 GROUP | – | Procedure: tumorectomy with axillary dissection (sentinel lymph node), Radiation: per-operative partial irradiationPatient 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 |
Who may qualify
- Ages
- 60 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Invasive breast cancer with a good prognosis that is accessible to breast-conserving surgery
Key inclusion criteria (9 listed)
- 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+),
Key exclusion criteria (8 listed)
- -. Inflammatory breast cancer,
- Associated peri-tumoral lymphatic emboli
- Associated extensive intra-ductal component
- Invasive lobular carcinoma
- Pure ductal carcinoma in situ,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tumorectomy with axillary dissection (sentinel lymph node)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. | Procedure or surgery | 1 GROUP |
| per-operative partial irradiation20 Gy of per-operative partial irradiation at the tumor site during the surgery | Radiation | 1 GROUP |
Primary outcome
Number of Patient With a Local Intra-mammary Relapse
Time frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
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
4 secondary outcomes
Cosmetic Results
Time frame: post surgery : 3 weeks, 6 months and 12 months
Patients' Satisfaction Towards the Treatment
Time frame: post surgery : 3 weeks, 6 months and 12 months
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
Time frame: post surgery : 3 weeks, 6 months and 12 months
Overall Survival
Time frame: from baseline to 10 years after treatment
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jun 2026.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Background: PubMed 11768604Grosclaude 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.
- Background: PubMed 10904087van 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.
- Background: PubMed 12393819Veronesi 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.
- Background: PubMed 16360786Clarke 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.
- Background: PubMed 17577015Bartelink 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.
- Background: PubMed 9263806Dubois 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.
- Background: PubMed 16442241Lemanski 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.
- Background: PubMed 19467579Lemanski 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.
- Background: PubMed 19632605Smith 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.
- Background: PubMed 12393820Fisher 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.
- Background: PubMed 11571720Vlastos 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.
- Background: PubMed 14734701Vinh-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.
- Institut de Veille Sanitaire- Institut National du CancerLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. All data will be available after publication of the results in peer-reviewed revues, and in national and international meetings. It includes all de-identified participants' data, the study protocol, the statistical analysis plan and the clinical study report. The corresponding author will provide data and datasets generated and/or analyzed during the study upon reasonable request.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
LEMANSKI Claire, DR study chair
ICM Val d'Aurelle DRCI
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Invasive Breast Cancer and Breast-conserving Surgery, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 9 inclusion and 8 exclusion criteria. 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: under way, not looking for participants, as of the sponsor's last update on 23 Jun 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 2 Apr 2025). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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.
What does the primary outcome measure?
Number of Patient With a Local Intra-mammary Relapse (time frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04414202, which also lists 12 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 23 Jun 2026.