Trial Outcomes & Findings for Observational Study of Intra-operative Partial Irradiation of Invasive Ductal Breast Carcinomas With a Good Prognosis (NCT NCT04414202)
NCT ID: NCT04414202
Last Updated: 2025-04-02
Results Overview
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
Recruitment status
ACTIVE_NOT_RECRUITING
Target enrollment
519 participants
Primary outcome timeframe
post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
Results posted on
2025-04-02
Participant Flow
Participant milestones
| Measure |
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
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|---|---|
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Overall Study
STARTED
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519
|
|
Overall Study
COMPLETED
|
496
|
|
Overall Study
NOT COMPLETED
|
23
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
1 GROUP
n=519 Participants
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
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|---|---|
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Age, Continuous
|
69.54 years
n=519 Participants
|
|
Sex: Female, Male
Female
|
519 Participants
n=519 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=519 Participants
|
PRIMARY outcome
Timeframe: 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
Outcome measures
| Measure |
1 GROUP
n=519 Participants
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
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|---|---|
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Number of Patient With a Local Intra-mammary Relapse
no relapse
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498 Participants
|
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Number of Patient With a Local Intra-mammary Relapse
local relapse
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15 Participants
|
|
Number of Patient With a Local Intra-mammary Relapse
local and metastatic relapse
|
1 Participants
|
|
Number of Patient With a Local Intra-mammary Relapse
not specified
|
5 Participants
|
SECONDARY outcome
Timeframe: post surgery : 3 weeks, 6 months and 12 monthsPopulation: the number of patient wich respond to the cosmetic questionnaire differs from the Overall Number of Participants Analyzed
Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result")
Outcome measures
| Measure |
1 GROUP
n=519 Participants
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
|
|---|---|
|
Cosmetic Results
at 3 weeks after the treatment · very good cosmetic result
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208 Participants
|
|
Cosmetic Results
at 3 weeks after the treatment · good cosmetic result
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124 Participants
|
|
Cosmetic Results
at 3 weeks after the treatment · bad cosmetic result
|
12 Participants
|
|
Cosmetic Results
at 3 weeks after the treatment · very bad cosmetic result
|
0 Participants
|
|
Cosmetic Results
at 3 weeks after the treatment · no data
|
175 Participants
|
|
Cosmetic Results
at 6 months after the treatment · very good cosmetic result
|
198 Participants
|
|
Cosmetic Results
at 6 months after the treatment · good cosmetic result
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147 Participants
|
|
Cosmetic Results
at 6 months after the treatment · bad cosmetic result
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14 Participants
|
|
Cosmetic Results
at 6 months after the treatment · very bad cosmetic result
|
1 Participants
|
|
Cosmetic Results
at 6 months after the treatment · no data
|
159 Participants
|
|
Cosmetic Results
at 12 months after the treatment · very good cosmetic result
|
256 Participants
|
|
Cosmetic Results
at 12 months after the treatment · good cosmetic result
|
99 Participants
|
|
Cosmetic Results
at 12 months after the treatment · bad cosmetic result
|
9 Participants
|
|
Cosmetic Results
at 12 months after the treatment · very bad cosmetic result
|
1 Participants
|
|
Cosmetic Results
at 12 months after the treatment · no data
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154 Participants
|
SECONDARY outcome
Timeframe: post surgery : 3 weeks, 6 months and 12 monthsPopulation: patient no completed the Likert scale
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
Outcome measures
| Measure |
1 GROUP
n=519 Participants
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
|
|---|---|
|
Patients' Satisfaction Towards the Treatment
At 3 weeks after the treatment · Very good satisfaction
|
135 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 3 weeks after the treatment · good satisfaction
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200 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 3 weeks after the treatment · bad satisfaction
|
30 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 3 weeks after the treatment · very bad satisfaction
|
1 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 3 weeks after the treatment · missing
|
150 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 6 months after the treatment · Very good satisfaction
|
165 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 6 months after the treatment · good satisfaction
|
198 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 6 months after the treatment · bad satisfaction
|
20 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 6 months after the treatment · very bad satisfaction
|
1 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 6 months after the treatment · missing
|
97 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 12 months after the treatment · Very good satisfaction
|
173 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 12 months after the treatment · good satisfaction
|
188 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 12 months after the treatment · bad satisfaction
|
26 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 12 months after the treatment · very bad satisfaction
|
3 Participants
|
|
Patients' Satisfaction Towards the Treatment
At 12 months after the treatment · missing
|
71 Participants
|
SECONDARY outcome
Timeframe: post surgery : 3 weeks, 6 months and 12 monthsPopulation: patient no completed scale with the time
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")
Outcome measures
| Measure |
1 GROUP
n=519 Participants
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
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|---|---|
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Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 0 "no autonomy"
|
1 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 3
|
1 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 4
|
0 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 5
|
7 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 6
|
5 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 7
|
7 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 8
|
36 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 9
|
67 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · 10 "good autonomy"
|
246 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 3 weeks post treatment · Missing
|
146 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 0 "no autonomy"
|
0 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 3
|
0 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 4
|
1 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 5
|
9 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 6
|
2 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 7
|
10 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 8
|
41 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 9
|
65 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · 10 "good autonomy"
|
256 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 6 months post treatment · Missing
|
97 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 0 "no autonomy"
|
0 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 3
|
1 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 4
|
1 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 5
|
3 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 6
|
3 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 7
|
15 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 8
|
42 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 9
|
72 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · 10 "good autonomy"
|
250 Participants
|
|
Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients
At 12 months post treatment · Missing
|
74 Participants
|
SECONDARY outcome
Timeframe: from baseline to 10 years after treatmentrate of death
Outcome measures
| Measure |
1 GROUP
n=519 Participants
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
|
|---|---|
|
Overall Survival
Alive
|
441 Participants
|
|
Overall Survival
deceased
|
39 Participants
|
|
Overall Survival
lost of follow up
|
39 Participants
|
Adverse Events
1 GROUP
Serious events: 0 serious events
Other events: 519 other events
Deaths: 39 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
1 GROUP
n=519 participants at risk
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
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.
per-operative partial irradiation: 20 Gy of per-operative partial irradiation at the tumor site during the surgery
|
|---|---|
|
General disorders
atrophy
|
2.7%
14/519 • Number of events 14 • collection from the baseline to 120 months after treatment by radiotherapy
adverse event collected with CTCAE. no serious adverse event appeared
|
|
General disorders
cutaneous eruption
|
0.58%
3/519 • Number of events 3 • collection from the baseline to 120 months after treatment by radiotherapy
adverse event collected with CTCAE. no serious adverse event appeared
|
|
Musculoskeletal and connective tissue disorders
fibrosis
|
73.8%
383/519 • Number of events 383 • collection from the baseline to 120 months after treatment by radiotherapy
adverse event collected with CTCAE. no serious adverse event appeared
|
|
Musculoskeletal and connective tissue disorders
hyperpigmentation
|
18.7%
97/519 • Number of events 97 • collection from the baseline to 120 months after treatment by radiotherapy
adverse event collected with CTCAE. no serious adverse event appeared
|
|
Musculoskeletal and connective tissue disorders
erythema redness
|
7.3%
38/519 • Number of events 38 • collection from the baseline to 120 months after treatment by radiotherapy
adverse event collected with CTCAE. no serious adverse event appeared
|
|
Musculoskeletal and connective tissue disorders
telangiectasia
|
2.5%
13/519 • Number of events 13 • collection from the baseline to 120 months after treatment by radiotherapy
adverse event collected with CTCAE. no serious adverse event appeared
|
|
Musculoskeletal and connective tissue disorders
ulceration
|
0.77%
4/519 • Number of events 4 • collection from the baseline to 120 months after treatment by radiotherapy
adverse event collected with CTCAE. no serious adverse event appeared
|
Additional Information
Mme Aurore Moussion, Director of Direction of Clinical Research and Innovation
INSTITUT REGIONAL DU CANCER DE MONTPELLIER Cancer de Montpellier
Phone: 0467613102
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place