Trial Outcomes & Findings for Primary Operation in SYnchronous meTastasized InVasivE Breast Cancer (NCT NCT01015625)
NCT ID: NCT01015625
Last Updated: 2024-08-19
Results Overview
Overall Survival with vs without local therapy (surgery)
Recruitment status
COMPLETED
Study phase
NA
Target enrollment
90 participants
Primary outcome timeframe
Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months
Results posted on
2024-08-19
Participant Flow
The first patient was randomized November 24, 2010, the last patient was randomized October 30, 2015. Randomization took place in 14 Austrian clinical sites. In total, 90 patients were enrolled.
Participant milestones
| Measure |
A: Surgical Therapy
Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
|
B: Surgery on Demand
In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.
Surgery on Demand: if necessary local therapy on demand
|
|---|---|---|
|
Overall Study
STARTED
|
45
|
45
|
|
Overall Study
COMPLETED
|
8
|
19
|
|
Overall Study
NOT COMPLETED
|
37
|
26
|
Reasons for withdrawal
| Measure |
A: Surgical Therapy
Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
|
B: Surgery on Demand
In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.
Surgery on Demand: if necessary local therapy on demand
|
|---|---|---|
|
Overall Study
Lost to Follow-up
|
3
|
1
|
|
Overall Study
Withdrawal by Subject
|
2
|
3
|
|
Overall Study
Physician Decision
|
2
|
0
|
|
Overall Study
Death
|
30
|
22
|
Baseline Characteristics
Race and Ethnicity were not collected from any participant.
Baseline characteristics by cohort
| Measure |
A: Surgical Therapy
n=45 Participants
Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
|
B: Surgery on Demand
n=45 Participants
In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.
Surgery on Demand: if necessary local therapy on demand
|
Total
n=90 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
62 years
n=45 Participants
|
65 years
n=45 Participants
|
64 years
n=90 Participants
|
|
Sex: Female, Male
Female
|
45 Participants
n=45 Participants
|
45 Participants
n=45 Participants
|
90 Participants
n=90 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=45 Participants
|
0 Participants
n=45 Participants
|
0 Participants
n=90 Participants
|
|
Race and Ethnicity Not Collected
|
—
|
—
|
0 Participants
Race and Ethnicity were not collected from any participant.
|
|
T-stage
cT1
|
11 Participants
n=45 Participants
|
7 Participants
n=45 Participants
|
18 Participants
n=90 Participants
|
|
T-stage
cT2
|
14 Participants
n=45 Participants
|
26 Participants
n=45 Participants
|
40 Participants
n=90 Participants
|
|
T-stage
cT3
|
10 Participants
n=45 Participants
|
3 Participants
n=45 Participants
|
13 Participants
n=90 Participants
|
|
T-stage
cT4
|
8 Participants
n=45 Participants
|
8 Participants
n=45 Participants
|
16 Participants
n=90 Participants
|
|
T-stage
Unkown
|
2 Participants
n=45 Participants
|
1 Participants
n=45 Participants
|
3 Participants
n=90 Participants
|
|
N-stage
cN0
|
10 Participants
n=45 Participants
|
10 Participants
n=45 Participants
|
20 Participants
n=90 Participants
|
|
N-stage
cN1
|
20 Participants
n=45 Participants
|
21 Participants
n=45 Participants
|
41 Participants
n=90 Participants
|
|
N-stage
cN2
|
7 Participants
n=45 Participants
|
2 Participants
n=45 Participants
|
9 Participants
n=90 Participants
|
|
N-stage
cN3
|
4 Participants
n=45 Participants
|
2 Participants
n=45 Participants
|
6 Participants
n=90 Participants
|
|
N-stage
Unknown
|
4 Participants
n=45 Participants
|
10 Participants
n=45 Participants
|
14 Participants
n=90 Participants
|
|
Histologic grade
G1
|
5 Participants
n=45 Participants
|
2 Participants
n=45 Participants
|
7 Participants
n=90 Participants
|
|
Histologic grade
G2
|
23 Participants
n=45 Participants
|
25 Participants
n=45 Participants
|
48 Participants
n=90 Participants
|
|
Histologic grade
G3
|
13 Participants
n=45 Participants
|
15 Participants
n=45 Participants
|
28 Participants
n=90 Participants
|
|
Histologic grade
Gx
|
3 Participants
n=45 Participants
|
1 Participants
n=45 Participants
|
4 Participants
n=90 Participants
|
|
Histologic grade
Unknown
|
1 Participants
n=45 Participants
|
2 Participants
n=45 Participants
|
3 Participants
n=90 Participants
|
|
Hormone receptor group
Estrogen and Progesterone negative
|
9 Participants
n=45 Participants
|
8 Participants
n=45 Participants
|
17 Participants
n=90 Participants
|
|
Hormone receptor group
Any positive
|
36 Participants
n=45 Participants
|
37 Participants
n=45 Participants
|
73 Participants
n=90 Participants
|
|
HER2 group
FISH amplified/IHC+++
|
10 Participants
n=45 Participants
|
8 Participants
n=45 Participants
|
18 Participants
n=90 Participants
|
|
HER2 group
Negative
|
35 Participants
n=45 Participants
|
36 Participants
n=45 Participants
|
71 Participants
n=90 Participants
|
|
HER2 group
Unknown
|
0 Participants
n=45 Participants
|
1 Participants
n=45 Participants
|
1 Participants
n=90 Participants
|
|
Surgery type
Breast-conserving
|
12 Participants
n=45 Participants
|
3 Participants
n=45 Participants
|
15 Participants
n=90 Participants
|
|
Surgery type
Modified radical
|
30 Participants
n=45 Participants
|
4 Participants
n=45 Participants
|
34 Participants
n=90 Participants
|
|
Surgery type
Missing
|
3 Participants
n=45 Participants
|
38 Participants
n=45 Participants
|
41 Participants
n=90 Participants
|
PRIMARY outcome
Timeframe: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 monthsPopulation: Intent-to-treat population: All participants assigned to one of the two treatment arms were included in the analysis
Overall Survival with vs without local therapy (surgery)
Outcome measures
| Measure |
A: Surgical Therapy
n=45 Participants
Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
|
B: Surgery on Demand
n=45 Participants
In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.
Surgery on Demand: if necessary local therapy on demand
|
|---|---|---|
|
Overall Survival (OS)
|
34.6 months
Interval 25.4 to 47.9
|
56.2 months
Interval 34.0 to
Not applicable, confidence limit cannot be calculated due to insufficient number of participants with events.
|
SECONDARY outcome
Timeframe: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 monthsPopulation: Intent-to-treat population: All participants assigned to one of the two treatment arms were included in the analysis
Time to distant progression with vs without local therapy (surgery)
Outcome measures
| Measure |
A: Surgical Therapy
n=45 Participants
Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
|
B: Surgery on Demand
n=45 Participants
In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.
Surgery on Demand: if necessary local therapy on demand
|
|---|---|---|
|
Time to Distant Progression
|
13.7 months
Interval 5.9 to 20.0
|
24.4 months
Interval 12.2 to 41.0
|
SECONDARY outcome
Timeframe: Time from randomization until the last visit of the last participant; maximum time on study was 63.9 monthsPopulation: Intent-to-treat population: All participants assigned to one of the two treatment arms were included in the analysis
Time to local progression with vs without local therapy (surgery)
Outcome measures
| Measure |
A: Surgical Therapy
n=45 Participants
Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory).
Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II)
|
B: Surgery on Demand
n=45 Participants
In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat.
Surgery on Demand: if necessary local therapy on demand
|
|---|---|---|
|
Time to Local Progression (TTPl)
|
59.4 months
Interval 43.1 to
Not applicable, confidence limit cannot be calculated due to insufficient number of participants with events.
|
55.8 months
Interval 54.1 to
Not applicable, confidence limit cannot be calculated due to insufficient number of participants with events.
|
Adverse Events
A: Surgical Therapy
Serious events: 0 serious events
Other events: 0 other events
Deaths: 30 deaths
B: Surgery on Demand
Serious events: 0 serious events
Other events: 0 other events
Deaths: 22 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
Adverse event data not reported
Additional Information
Trial Office Director
ABCSG (Austrian Breast & Colorectal Cancer Study Group)
Phone: +43 1 4089230
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place