Breast-conserving Surgery, Invasive Breast Cancer
Conditions
Keywords
breast cancer, good prognosis, surgery, intra-operative partial irradiation
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.
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
Interventions
PROCEDUREtumorectomy 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.
RADIATIONper-operative partial irradiation
20 Gy of per-operative partial irradiation at the tumor site during the surgery
Sponsors
Institut du Cancer de Montpellier - Val d'Aurelle
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
60 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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.
Exclusion criteria
-. 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Patient With a Local Intra-mammary Relapse | 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 |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Cosmetic Results | post surgery : 3 weeks, 6 months and 12 months | Evaluation of the cosmetic result of questionnaire (0 "no satisfy with the cosmetic result"" from 10 "very satisfy with the cosmetic result") |
| Patients' Satisfaction Towards the Treatment | post surgery : 3 weeks, 6 months and 12 months | Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy) |
| Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | post surgery : 3 weeks, 6 months and 12 months | 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") |
| Overall Survival | from baseline to 10 years after treatment | rate of death |
Countries
France
Contacts
STUDY_CHAIRLEMANSKI Claire, DR
ICM Val d'Aurelle DRCI
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| 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 | 519 |
| Total | 519 |
Baseline characteristics
| Characteristic | 1 GROUP |
|---|---|
| Age, Continuous | 69.54 years |
| Sex: Female, Male Female | 519 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 39 / 519 |
| other Total, other adverse events | 519 / 519 |
| serious Total, serious adverse events | 0 / 519 |
Outcome results
Primary
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
Time frame: post surgery : 3 weeks, every 6 months during 5 years and annually during 5 years (10 years in total)
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1 GROUP | Number of Patient With a Local Intra-mammary Relapse | no relapse | 498 Participants |
| 1 GROUP | Number of Patient With a Local Intra-mammary Relapse | local relapse | 15 Participants |
| 1 GROUP | Number of Patient With a Local Intra-mammary Relapse | local and metastatic relapse | 1 Participants |
| 1 GROUP | Number of Patient With a Local Intra-mammary Relapse | not specified | 5 Participants |
Secondary
Cosmetic Results
Evaluation of the cosmetic result of questionnaire (0 no satisfy with the cosmetic result from 10 very satisfy with the cosmetic result)
Time frame: post surgery : 3 weeks, 6 months and 12 months
Population: the number of patient wich respond to the cosmetic questionnaire differs from the Overall Number of Participants Analyzed
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 1 GROUP | Cosmetic Results | at 3 weeks after the treatment | very good cosmetic result | 208 Participants |
| 1 GROUP | Cosmetic Results | at 3 weeks after the treatment | good cosmetic result | 124 Participants |
| 1 GROUP | Cosmetic Results | at 3 weeks after the treatment | bad cosmetic result | 12 Participants |
| 1 GROUP | Cosmetic Results | at 3 weeks after the treatment | very bad cosmetic result | 0 Participants |
| 1 GROUP | Cosmetic Results | at 3 weeks after the treatment | no data | 175 Participants |
| 1 GROUP | Cosmetic Results | at 6 months after the treatment | very good cosmetic result | 198 Participants |
| 1 GROUP | Cosmetic Results | at 6 months after the treatment | good cosmetic result | 147 Participants |
| 1 GROUP | Cosmetic Results | at 6 months after the treatment | bad cosmetic result | 14 Participants |
| 1 GROUP | Cosmetic Results | at 6 months after the treatment | very bad cosmetic result | 1 Participants |
| 1 GROUP | Cosmetic Results | at 6 months after the treatment | no data | 159 Participants |
| 1 GROUP | Cosmetic Results | at 12 months after the treatment | very good cosmetic result | 256 Participants |
| 1 GROUP | Cosmetic Results | at 12 months after the treatment | good cosmetic result | 99 Participants |
| 1 GROUP | Cosmetic Results | at 12 months after the treatment | bad cosmetic result | 9 Participants |
| 1 GROUP | Cosmetic Results | at 12 months after the treatment | very bad cosmetic result | 1 Participants |
| 1 GROUP | Cosmetic Results | at 12 months after the treatment | no data | 154 Participants |
Secondary
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)
Time frame: post surgery : 3 weeks, 6 months and 12 months
Population: patient no completed scale with the time
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 6 | 2 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 7 | 10 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 0 no autonomy | 1 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 3 | 1 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 4 | 0 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 5 | 7 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 6 | 5 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 7 | 7 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 8 | 36 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 9 | 67 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | 10 good autonomy | 246 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 3 weeks post treatment | Missing | 146 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 0 no autonomy | 0 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 3 | 0 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 4 | 1 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 5 | 9 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 8 | 41 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 9 | 65 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | 10 good autonomy | 256 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 6 months post treatment | Missing | 97 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 0 no autonomy | 0 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 3 | 1 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 4 | 1 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 5 | 3 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 6 | 3 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 7 | 15 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 8 | 42 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 9 | 72 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | 10 good autonomy | 250 Participants |
| 1 GROUP | Impact of the Accelerated Treatment on the Maintenance of Autonomy in Elderly Patients | At 12 months post treatment | Missing | 74 Participants |
Secondary
Overall Survival
rate of death
Time frame: from baseline to 10 years after treatment
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| 1 GROUP | Overall Survival | Alive | 441 Participants |
| 1 GROUP | Overall Survival | deceased | 39 Participants |
| 1 GROUP | Overall Survival | lost of follow up | 39 Participants |
Secondary
Patients' Satisfaction Towards the Treatment
Satisfaction will be measured using the Likert scale (0 no satisfy to 10: strongly satisfy)
Time frame: post surgery : 3 weeks, 6 months and 12 months
Population: patient no completed the Likert scale
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 3 weeks after the treatment | Very good satisfaction | 135 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 3 weeks after the treatment | good satisfaction | 200 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 3 weeks after the treatment | bad satisfaction | 30 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 3 weeks after the treatment | very bad satisfaction | 1 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 3 weeks after the treatment | missing | 150 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 6 months after the treatment | Very good satisfaction | 165 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 6 months after the treatment | good satisfaction | 198 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 6 months after the treatment | bad satisfaction | 20 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 6 months after the treatment | very bad satisfaction | 1 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 6 months after the treatment | missing | 97 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 12 months after the treatment | Very good satisfaction | 173 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 12 months after the treatment | good satisfaction | 188 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 12 months after the treatment | bad satisfaction | 26 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 12 months after the treatment | very bad satisfaction | 3 Participants |
| 1 GROUP | Patients' Satisfaction Towards the Treatment | At 12 months after the treatment | missing | 71 Participants |