Breast CancerSAHARA-01NCT04282122
Clinical Database of Safe Personalized Adjuvant Breast Radiotherapy Based on Individual Radiosensitivity
An observational study of Breast Cancer, run by Institut du Cancer de Montpellier - Val d'Aurelle at 1 site in France.
Trial summary
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Read more about this study
- Who is it for?
- Ages 65 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Radiotherapy
- Type of treatment
- Surgery or procedure
- How many people
- 500 participants
- Where
- 1 siteFrance
- Study dates
- 23 May 2019to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
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 65 years and older
- Women only
- No healthy volunteers
- Older adult
Study population: Patients treated with safe adjuvant therapy by personalized radiation based on individual radiosensitivity after resection of breast tumor
Who may be able to join
- Compliant women ≥ 65 years old.
- Conservative breast cancer surgery.
- T1-T2; N sentinel negative/N0.
- Luminal A tumors.
- Tumor negative margins.
- Indication of whole breast irradiation only.
Show all 10Show fewer
- Extension evaluation of disease will be proven negative (M0).
- Must be geographically accessible for follow-up.
- Written and dated informed consent.
- Affiliated to the French social security system.
Who cannot join
- Patients with distant metastases.
- Indications of node irradiation.
- Synchronous bilateral breast cancer.
- Patients treated by radical mastectomy.
- Patients with neoadjuvant therapy.
- Patients with previous or concomitant other (not breast cancer) malignancy within the past 3 years EXCEPT adequately treated basal or squamous cell carcinoma of the skin or in situ carcinoma of the cervix. Patients who have had a previous other malignancy must have been disease free for at least three years.
- Patients with other unstable or untreated non-malignant systemic diseases (cardiovascular, renal, hepatic, lung embolism, etc.) which would prevent prolonged follow-up.
- Patients treated with systemic investigational drugs within the past 30 days
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Institut Régional du Cancer de Montpellier
Montpellier, Occ, 34298
Jean-Pierre BLEUSE, MD, 0467613102 ext. +33, DRCI-icm105@icm.unicancer.fr
Céline BOURGIER, MD
About this study
Official title: Establishment of a Prospective Evaluation of Daily Practice Including the Individual Radiosensitivity Test to the Decision of Daily Practice
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity.
In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed.
Read more
Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small [6].
Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy.
Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials [13, 14] showed only few late effects when hypofractionation was delivered to the whole breast (WB). These results reinforce the need of patients' selection using the NovaGray Breast® test.
Our hypothesis is therefore that the different techniques (volume reduction or hypofractionation) as well as radiotherapy omission will significantly reduce grade ≥2 bf+ in a personalized approach (driven by a predictive assay of late effects) compared to WB hypofractionation in a selected population at low risk of breast recurrence.
We would like to establish a prospective evaluation of daily practice including the individual radiosensitivity test to the decision of daily practice
Read the detailed description
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity.
In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed. The NovaGray Breast® test combines both a biological analysis (radio-induced lymphocyte apoptosis) and a predictive analysis, including external parameters related to the patient and her treatment. A negative predictive value (>90%) was found in case of high RILA taken alone and a sensitivity of 80% to detect the toxicity with an initial AUC of 0.61. In addition, including significant clinical parameters, the AUC was increased to 0.69. Moreover, a prognosis model with RILA alone to predict the probability to develop a toxicity and performance of the model was increased with the inclusion of significant clinical parameters (C-Harell 0.61 >> 0.69).
The NovaGray Breast® test is now validated after two prospective trials, one French (PHRC) and one European (Requite FP7). RILA and other factors have been confirmed to be independent factors that increase significantly the appearance of severe breast fibrosis. All these data have been merged into a nomogram allowing a predictive tool for daily clinical practice and then to customize radiotherapy techniques and indications.
In the meantime, several treatment modifications have been suggested to reduce late effects after breast radiotherapy:
Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small [6]. In addition, low risk of recurrence was confirmed in randomized trials in a highly selected population. However, omitting radiotherapy and using intrinsic subtyping and clinical factors is a substantial change in care and could be driven by the risk of toxicity.
Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy. The first two techniques are reserved for trained and expert centres but showed encouraging results with low toxicity rates and recurrences. The recent experience of external partial breast irradiation (EPBI) with twice daily fractions regimen showed an increase risk of late side-effects leading to use hypofractionated EPBI (hEPBI) once daily, 5 days a week. This regimen could only be used in case of selecting patients with NovaGray Breast®test without individual risk of late effects.
Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials showed only few late effects when hypofractionation was delivered to the whole breast (WB). Nevertheless, It has been shown in the TRANS-FAST trial a significant decrease of grade ≥2 bf+ for increasing values of RILA in the same extent than observed with conventional fractional schedules. These results reinforce the need of patients' selection using the NovaGray Breast® test.
- Conditions
- Breast Cancer
- Being tested
- Radiotherapy
- Keywords
- breast cancer, oncology, database, radiotherapy
- Medical subject headings
- Breast Neoplasms, Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RadiotherapyRadiation
curative-intent radiotherapy
What is being measured
The primary outcome is the main question the study is designed to answer.
Acute and late breast fibrosis rate
Describe the acute and late breast fibrosis rate in daily practice according to the individual radiosensitivity, assessed by the NovaGray RILA Breast® test
Measured: Until the study completion: 5 years
Secondary outcomes (1)
Quality of life according to the EORTC QLQ-C30
Evaluate the quality of life according to the EORTC QLQ-C30
Measured: Until the study completion: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2020
- Study start23 May 2019
- Primary completionDec 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for 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
- Other
- Time perspective
- Prospective
- Enrolment
- 500 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Céline BOURGIER, MD, Study chair, Institut Régional du Cancer de Montpellier (ICM)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04282122
- Sponsor's protocol ID
- PROICM 2018-09 BSA
- Acronym
- SAHARA-01
- Status last verified
- Nov 2026
- First submitted
- 21 Oct 2019
- Last updated
- 6 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Bourgier C, Castan F, Riou O, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Rivera S, Noel G, Clippe S, Mornex F, Hennequin C, Gourgou S, Brengues M, Fenoglietto P, Ozsahin EM, Azria D. Impact of adjuvant hormonotherapy on radiation-induced breast fibrosis according to the individual radiosensitivity: results of a multicenter prospective French trial. Oncotarget. 2018 Mar 2;9(21):15757-15765. doi: 10.18632/oncotarget.24606. eCollection 2018 Mar 20.
PubMed 29644007Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33. doi: 10.1158/1078-0432.CCR-04-2634.
PubMed 16243816Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60. doi: 10.1038/sj.bjc.6602146.
PubMed 15328527Xiao B, Chen L, Ke Y, Hang J, Cao L, Zhang R, Zhang W, Liao Y, Gao Y, Chen J, Li L, Hao W, Sun Z, Li L. Identification of methylation sites and signature genes with prognostic value for luminal breast cancer. BMC Cancer. 2018 Apr 11;18(1):405. doi: 10.1186/s12885-018-4314-9.
PubMed 29642861Vaidya JS, Wenz F, Bulsara M, Tobias JS, Joseph DJ, Keshtgar M, Flyger HL, Massarut S, Alvarado M, Saunders C, Eiermann W, Metaxas M, Sperk E, Sutterlin M, Brown D, Esserman L, Roncadin M, Thompson A, Dewar JA, Holtveg HM, Pigorsch S, Falzon M, Harris E, Matthews A, Brew-Graves C, Potyka I, Corica T, Williams NR, Baum M; TARGIT trialists' group. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2014 Feb 15;383(9917):603-13. doi: 10.1016/S0140-6736(13)61950-9. Epub 2013 Nov 11.
PubMed 24224997Strnad 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.
PubMed 26494415Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.
PubMed 23835717Kunkler IH, Williams LJ, Jack WJ, Cameron DA, Dixon JM; PRIME II investigators. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial. Lancet Oncol. 2015 Mar;16(3):266-73. doi: 10.1016/S1470-2045(14)71221-5. Epub 2015 Jan 28.
PubMed 25637340Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.
PubMed 24055415
Study at a glance
From the registry record, last updated by the sponsor on 6 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Establishment of a Prospective Evaluation of Daily Practice Including the Individual Radiosensitivity Test to the Decision of Daily Practice
- ClinicalTrials.gov ID
- NCT04282122
- Acronym / sponsor ID
- SAHARA-01 / PROICM 2018-09 BSA
- Conditions
- Breast Cancer
- Keywords
- breast cancer, oncology, database, radiotherapy
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 500 participants (estimated)
- Lead sponsor
- Institut du Cancer de Montpellier - Val d'AurelleUniversity, hospital or other
- Study start
- 23 May 2019 (actual)
- Primary completion
- Dec 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 24 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity.
In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed.
Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small [6].
Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy.
Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials [13, 14] showed only few late effects when hypofractionation was delivered to the whole breast (WB). These results reinforce the need of patients' selection using the NovaGray Breast® test.
Our hypothesis is therefore that the different techniques (volume reduction or hypofractionation) as well as radiotherapy omission will significantly reduce grade ≥2 bf+ in a personalized approach (driven by a predictive assay of late effects) compared to WB hypofractionation in a selected population at low risk of breast recurrence.
We would like to establish a prospective evaluation of daily practice including the individual radiosensitivity test to the decision of daily practice
Detailed description
Severe but also moderate toxicities after curative-intent radiotherapy (RT), such as a poor cosmetic outcome following breast cancer can have a negative impact on quality of life and a marked effect on subsequent psychological outcome. Nevertheless, current practice standards commonly prescribe radiation dose and volume without regard to individual radiosensitivity.
In that context, a normal tissue radiosensitivity test that includes a rapid (72 h) radiosensitivity assay based on flow cytometric assessment of radiation-induced CD8 T-lymphocyte apoptosis (RILA) and other significant clinical parameters (multifactorial nomogram) was developed. The NovaGray Breast® test combines both a biological analysis (radio-induced lymphocyte apoptosis) and a predictive analysis, including external parameters related to the patient and her treatment. A negative predictive value (>90%) was found in case of high RILA taken alone and a sensitivity of 80% to detect the toxicity with an initial AUC of 0.61. In addition, including significant clinical parameters, the AUC was increased to 0.69. Moreover, a prognosis model with RILA alone to predict the probability to develop a toxicity and performance of the model was increased with the inclusion of significant clinical parameters (C-Harell 0.61 >> 0.69).
The NovaGray Breast® test is now validated after two prospective trials, one French (PHRC) and one European (Requite FP7). RILA and other factors have been confirmed to be independent factors that increase significantly the appearance of severe breast fibrosis. All these data have been merged into a nomogram allowing a predictive tool for daily clinical practice and then to customize radiotherapy techniques and indications.
In the meantime, several treatment modifications have been suggested to reduce late effects after breast radiotherapy:
Omission of radiotherapy has been suggested when luminal A tumor subtype is combined with clinical and pathologic factors defining a subgroup of patients with a low risk of ipsilateral breast recurrence. In this group, the benefits of radiotherapy are small [6]. In addition, low risk of recurrence was confirmed in randomized trials in a highly selected population. However, omitting radiotherapy and using intrinsic subtyping and clinical factors is a substantial change in care and could be driven by the risk of toxicity.
Reduction of the breast irradiated volume is also a possibility that has been tested and published using IORT, brachytherapy or external beam radiotherapy. The first two techniques are reserved for trained and expert centres but showed encouraging results with low toxicity rates and recurrences. The recent experience of external partial breast irradiation (EPBI) with twice daily fractions regimen showed an increase risk of late side-effects leading to use hypofractionated EPBI (hEPBI) once daily, 5 days a week. This regimen could only be used in case of selecting patients with NovaGray Breast®test without individual risk of late effects.
Hypofractionation has been adapted to breast cancer radiotherapy. Overall, all recent clinical trials showed only few late effects when hypofractionation was delivered to the whole breast (WB). Nevertheless, It has been shown in the TRANS-FAST trial a significant decrease of grade ≥2 bf+ for increasing values of RILA in the same extent than observed with conventional fractional schedules. These results reinforce the need of patients' selection using the NovaGray Breast® test.
Study design
- Observational model
- Other
- Time perspective
- Prospective
Who may qualify
- Ages
- 65 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- Patients treated with safe adjuvant therapy by personalized radiation based on individual radiosensitivity after resection of breast tumor
Key inclusion criteria (10 listed)
- Compliant women ≥ 65 years old.
- Conservative breast cancer surgery.
- T1-T2; N sentinel negative/N0.
- Luminal A tumors.
- Tumor negative margins.
Key exclusion criteria (8 listed)
- Patients with distant metastases.
- Indications of node irradiation.
- Synchronous bilateral breast cancer.
- Patients treated by radical mastectomy.
- Patients with neoadjuvant therapy.
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 |
|---|---|---|
| Radiotherapycurative-intent radiotherapy | Radiation | – |
Primary outcome
Acute and late breast fibrosis rate
Time frame: Until the study completion: 5 years
Describe the acute and late breast fibrosis rate in daily practice according to the individual radiosensitivity, assessed by the NovaGray RILA Breast® test
1 secondary outcome
Quality of life according to the EORTC QLQ-C30
Time frame: Until the study completion: 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 6 Nov 2026.
- Background: PubMed 29644007Bourgier C, Castan F, Riou O, Nguyen TD, Peignaux K, Lemanski C, Lagrange JL, Kirova Y, Lartigau E, Belkacemi Y, Rivera S, Noel G, Clippe S, Mornex F, Hennequin C, Gourgou S, Brengues M, Fenoglietto P, Ozsahin EM, Azria D. Impact of adjuvant hormonotherapy on radiation-induced breast fibrosis according to the individual radiosensitivity: results of a multicenter prospective French trial. Oncotarget. 2018 Mar 2;9(21):15757-15765. doi: 10.18632/oncotarget.24606. eCollection 2018 Mar 20.
- Background: PubMed 16243816Ozsahin M, Crompton NE, Gourgou S, Kramar A, Li L, Shi Y, Sozzi WJ, Zouhair A, Mirimanoff RO, Azria D. CD4 and CD8 T-lymphocyte apoptosis can predict radiation-induced late toxicity: a prospective study in 399 patients. Clin Cancer Res. 2005 Oct 15;11(20):7426-33. doi: 10.1158/1078-0432.CCR-04-2634.
- Background: PubMed 15328527Azria D, Gourgou S, Sozzi WJ, Zouhair A, Mirimanoff RO, Kramar A, Lemanski C, Dubois JB, Romieu G, Pelegrin A, Ozsahin M. Concomitant use of tamoxifen with radiotherapy enhances subcutaneous breast fibrosis in hypersensitive patients. Br J Cancer. 2004 Oct 4;91(7):1251-60. doi: 10.1038/sj.bjc.6602146.
- Background: PubMed 29642861Xiao B, Chen L, Ke Y, Hang J, Cao L, Zhang R, Zhang W, Liao Y, Gao Y, Chen J, Li L, Hao W, Sun Z, Li L. Identification of methylation sites and signature genes with prognostic value for luminal breast cancer. BMC Cancer. 2018 Apr 11;18(1):405. doi: 10.1186/s12885-018-4314-9.
- Background: PubMed 24224997Vaidya JS, Wenz F, Bulsara M, Tobias JS, Joseph DJ, Keshtgar M, Flyger HL, Massarut S, Alvarado M, Saunders C, Eiermann W, Metaxas M, Sperk E, Sutterlin M, Brown D, Esserman L, Roncadin M, Thompson A, Dewar JA, Holtveg HM, Pigorsch S, Falzon M, Harris E, Matthews A, Brew-Graves C, Potyka I, Corica T, Williams NR, Baum M; TARGIT trialists' group. Risk-adapted targeted intraoperative radiotherapy versus whole-breast radiotherapy for breast cancer: 5-year results for local control and overall survival from the TARGIT-A randomised trial. Lancet. 2014 Feb 15;383(9917):603-13. doi: 10.1016/S0140-6736(13)61950-9. Epub 2013 Nov 11.
- Background: PubMed 26494415Strnad 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.
- Background: PubMed 23835717Olivotto IA, Whelan TJ, Parpia S, Kim DH, Berrang T, Truong PT, Kong I, Cochrane B, Nichol A, Roy I, Germain I, Akra M, Reed M, Fyles A, Trotter T, Perera F, Beckham W, Levine MN, Julian JA. Interim cosmetic and toxicity results from RAPID: a randomized trial of accelerated partial breast irradiation using three-dimensional conformal external beam radiation therapy. J Clin Oncol. 2013 Nov 10;31(32):4038-45. doi: 10.1200/JCO.2013.50.5511. Epub 2013 Jul 8.
- Background: PubMed 25637340Kunkler IH, Williams LJ, Jack WJ, Cameron DA, Dixon JM; PRIME II investigators. Breast-conserving surgery with or without irradiation in women aged 65 years or older with early breast cancer (PRIME II): a randomised controlled trial. Lancet Oncol. 2015 Mar;16(3):266-73. doi: 10.1016/S1470-2045(14)71221-5. Epub 2015 Jan 28.
- Background: PubMed 24055415Haviland JS, Owen JR, Dewar JA, Agrawal RK, Barrett J, Barrett-Lee PJ, Dobbs HJ, Hopwood P, Lawton PA, Magee BJ, Mills J, Simmons S, Sydenham MA, Venables K, Bliss JM, Yarnold JR; START Trialists' Group. The UK Standardisation of Breast Radiotherapy (START) trials of radiotherapy hypofractionation for treatment of early breast cancer: 10-year follow-up results of two randomised controlled trials. Lancet Oncol. 2013 Oct;14(11):1086-1094. doi: 10.1016/S1470-2045(13)70386-3. Epub 2013 Sep 19.
- Individual participant dataSharing planned: No
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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.
Céline BOURGIER, MD study chair
Institut Régional du Cancer de Montpellier (ICM)
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 Breast Cancer, 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 10 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: looking for participants now, as of the sponsor's last update on 6 Nov 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jean-Pierre BLEUSE, MD (0467613102 ext. +33, DRCI-icm105@icm.unicancer.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Acute and late breast fibrosis rate (time frame: Until the study completion: 5 years). 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 NCT04282122, which also lists 9 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 6 Nov 2026.