Trial Outcomes & Findings for MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer (NCT NCT01805076)
NCT ID: NCT01805076
Last Updated: 2026-06-26
Results Overview
Recruitment status
COMPLETED
Study phase
PHASE3
Target enrollment
319 participants
Primary outcome timeframe
Up to 5 years
Results posted on
2026-06-26
Participant Flow
Participant milestones
| Measure |
Arm 1 (Control)
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.\> \> Breast surgery\>
\> Mammography
|
Arm 2 (Experimental)
Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.\>
\> Breast surgery\>
\> Magnetic resonance imaging\>
\> Mammography
|
|---|---|---|
|
Overall Study
STARTED
|
158
|
161
|
|
Overall Study
COMPLETED
|
151
|
147
|
|
Overall Study
NOT COMPLETED
|
7
|
14
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
MRI and Mammography Before Surgery in Patients With Stage I-II Breast Cancer
Baseline characteristics by cohort
| Measure |
Arm 1 (Control)
n=158 Participants
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.\> \> Breast surgery\>
\> Mammography
|
Arm 2 (Experimental)
n=161 Participants
Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.\>
\> Breast surgery\>
\> Magnetic resonance imaging\>
\> Mammography
|
Total
n=319 Participants
Total of all reporting groups
|
|---|---|---|---|
|
Age, Continuous
|
61 years
n=20 Participants
|
58 years
n=20 Participants
|
59 years
n=40 Participants
|
|
Sex: Female, Male
Female
|
158 Participants
n=20 Participants
|
161 Participants
n=20 Participants
|
319 Participants
n=40 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
16 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
28 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
137 Participants
n=20 Participants
|
143 Participants
n=20 Participants
|
280 Participants
n=40 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
5 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
11 Participants
n=40 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Asian
|
3 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
10 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
0 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Black or African American
|
46 Participants
n=20 Participants
|
55 Participants
n=20 Participants
|
101 Participants
n=40 Participants
|
|
Race (NIH/OMB)
White
|
102 Participants
n=20 Participants
|
93 Participants
n=20 Participants
|
195 Participants
n=40 Participants
|
|
Race (NIH/OMB)
More than one race
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
6 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
12 Participants
n=40 Participants
|
|
Menopausal Status
Pre
|
18 Participants
n=20 Participants
|
34 Participants
n=20 Participants
|
52 Participants
n=40 Participants
|
|
Menopausal Status
Post
|
130 Participants
n=20 Participants
|
121 Participants
n=20 Participants
|
251 Participants
n=40 Participants
|
|
Menopausal Status
Peri
|
10 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
16 Participants
n=40 Participants
|
|
Receiving or recently completed neoadjuvant chemotherapy ?
Yes
|
25 Participants
n=20 Participants
|
31 Participants
n=20 Participants
|
56 Participants
n=40 Participants
|
|
Receiving or recently completed neoadjuvant chemotherapy ?
No
|
133 Participants
n=20 Participants
|
130 Participants
n=20 Participants
|
263 Participants
n=40 Participants
|
|
HER2 status
Positive
|
31 Participants
n=20 Participants
|
32 Participants
n=20 Participants
|
63 Participants
n=40 Participants
|
|
HER2 status
Negative
|
126 Participants
n=20 Participants
|
129 Participants
n=20 Participants
|
255 Participants
n=40 Participants
|
|
HER2 status
Unknown
|
1 Participants
n=20 Participants
|
0 Participants
n=20 Participants
|
1 Participants
n=40 Participants
|
|
Clinical T stage
T1
|
116 Participants
n=20 Participants
|
114 Participants
n=20 Participants
|
230 Participants
n=40 Participants
|
|
Clinical T stage
T2
|
41 Participants
n=20 Participants
|
46 Participants
n=20 Participants
|
87 Participants
n=40 Participants
|
|
Type of initial breast surgical procedure performed
Initial BCS
|
140 Participants
n=20 Participants
|
134 Participants
n=20 Participants
|
274 Participants
n=40 Participants
|
|
Clinical T stage
T3
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Clinical N stage
N0
|
147 Participants
n=20 Participants
|
151 Participants
n=20 Participants
|
298 Participants
n=40 Participants
|
|
Clinical N stage
N1
|
11 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Total number of lesions identified
1
|
131 Participants
n=20 Participants
|
140 Participants
n=20 Participants
|
271 Participants
n=40 Participants
|
|
Total number of lesions identified
2
|
25 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
43 Participants
n=40 Participants
|
|
Total number of lesions identified
3
|
1 Participants
n=20 Participants
|
2 Participants
n=20 Participants
|
3 Participants
n=40 Participants
|
|
Total number of lesions identified
4
|
1 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
2 Participants
n=40 Participants
|
|
Max lesion size (cm)
|
1.3 cm
n=20 Participants
|
1.3 cm
n=20 Participants
|
1.3 cm
n=40 Participants
|
|
Was ultrasound performed?
Yes
|
148 Participants
n=20 Participants
|
142 Participants
n=20 Participants
|
290 Participants
n=40 Participants
|
|
Was ultrasound performed?
No
|
3 Participants
n=20 Participants
|
5 Participants
n=20 Participants
|
8 Participants
n=40 Participants
|
|
Was ultrasound performed?
Missing
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Mastectomy?
No
|
137 Participants
n=20 Participants
|
134 Participants
n=20 Participants
|
271 Participants
n=40 Participants
|
|
Type of initial breast surgical procedure performed
Initial bilateral mastectomy
|
5 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Type of initial breast surgical procedure performed
Initial mastectomy
|
6 Participants
n=20 Participants
|
9 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
|
Type of initial breast surgical procedure performed
Patient did not have surgery
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Axillary Surgery
ALND only
|
3 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
9 Participants
n=40 Participants
|
|
Axillary Surgery
Both
|
4 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Axillary Surgery
Neither
|
1 Participants
n=20 Participants
|
4 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Axillary Surgery
SLN biopsy only
|
143 Participants
n=20 Participants
|
127 Participants
n=20 Participants
|
270 Participants
n=40 Participants
|
|
Axillary Surgery
Patient did not have surgery
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Reoperation?
No
|
137 Participants
n=20 Participants
|
129 Participants
n=20 Participants
|
266 Participants
n=40 Participants
|
|
Reoperation?
Yes
|
14 Participants
n=20 Participants
|
18 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Reoperation?
Patient did not have surgery
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Margin Status
< 2mm
|
34 Participants
n=20 Participants
|
39 Participants
n=20 Participants
|
73 Participants
n=40 Participants
|
|
Margin Status
>= 2mm
|
104 Participants
n=20 Participants
|
101 Participants
n=20 Participants
|
205 Participants
n=40 Participants
|
|
Margin Status
Positive (tumor at surgical margin)
|
10 Participants
n=20 Participants
|
10 Participants
n=20 Participants
|
20 Participants
n=40 Participants
|
|
Margin Status
Patient did not have surgery
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Mastectomy?
Yes
|
14 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
27 Participants
n=40 Participants
|
|
Mastectomy?
Patient did not have surgery
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Initial or Delayed Mastectomy
Delayed
|
4 Participants
n=20 Participants
|
1 Participants
n=20 Participants
|
5 Participants
n=40 Participants
|
|
Initial or Delayed Mastectomy
Initial
|
10 Participants
n=20 Participants
|
12 Participants
n=20 Participants
|
22 Participants
n=40 Participants
|
|
Initial or Delayed Mastectomy
Patient did not have mastectomy
|
137 Participants
n=20 Participants
|
134 Participants
n=20 Participants
|
271 Participants
n=40 Participants
|
|
Initial or Delayed Mastectomy
Patient did not have surgery
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Mastectomy Side
Bilateral
|
8 Participants
n=20 Participants
|
6 Participants
n=20 Participants
|
14 Participants
n=40 Participants
|
|
Mastectomy Side
Patient did not have mastectomy
|
137 Participants
n=20 Participants
|
134 Participants
n=20 Participants
|
271 Participants
n=40 Participants
|
|
Mastectomy Side
Unilateral
|
6 Participants
n=20 Participants
|
7 Participants
n=20 Participants
|
13 Participants
n=40 Participants
|
|
Mastectomy Side
Patient did not have surgery
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Did patient have adjuvant RT?
No
|
22 Participants
n=20 Participants
|
22 Participants
n=20 Participants
|
44 Participants
n=40 Participants
|
|
Did patient have adjuvant RT?
Yes
|
129 Participants
n=20 Participants
|
125 Participants
n=20 Participants
|
254 Participants
n=40 Participants
|
|
Did patient have adjuvant RT?
Missing
|
7 Participants
n=20 Participants
|
14 Participants
n=20 Participants
|
21 Participants
n=40 Participants
|
|
Did patient get systemic chemo?
No
|
19 Participants
n=20 Participants
|
13 Participants
n=20 Participants
|
32 Participants
n=40 Participants
|
|
Did patient get systemic chemo?
Yes
|
132 Participants
n=20 Participants
|
140 Participants
n=20 Participants
|
272 Participants
n=40 Participants
|
|
Did patient get systemic chemo?
Patient did not have surgery and did not have systemic chemo
|
7 Participants
n=20 Participants
|
8 Participants
n=20 Participants
|
15 Participants
n=40 Participants
|
PRIMARY outcome
Timeframe: Up to 5 yearsOutcome measures
| Measure |
Arm 1 (Control)
n=151 Participants
Patients undergo a clinical breast examination and mammography with ultrasound of the breast and regional nodes followed by breast conserving surgery.\> \> Breast surgery\>
\> Mammography
|
Arm 2 (Experimental)
n=147 Participants
Patients undergo a clinical breast examination, mammography with ultrasound of breast and regional nodes and breast MRI followed by breast conserving surgery or mastectomy.\>
\> Breast surgery\>
\> Magnetic resonance imaging\>
\> Mammography
|
|---|---|---|
|
Local-regional Recurrence (LRR)
|
95.7 percentage of participants
Interval 92.3 to 99.1
|
93.2 percentage of participants
Interval 89.0 to 97.6
|
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Within the first 6 monthsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 years post-randomizationOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: Up to 5 yearsOutcome measures
Outcome data not reported
Adverse Events
Arm 1 (Control)
Serious events: 0 serious events
Other events: 26 other events
Deaths: 13 deaths
Arm 2 (Experimental)
Serious events: 1 serious events
Other events: 28 other events
Deaths: 12 deaths
Serious adverse events
| Measure |
Arm 1 (Control)
n=158 participants at risk
Mammography
|
Arm 2 (Experimental)
n=161 participants at risk
Mammography
|
|---|---|---|
|
Reproductive system and breast disorders
Reproductive system and breast -Oth spec
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
Other adverse events
| Measure |
Arm 1 (Control)
n=158 participants at risk
Mammography
|
Arm 2 (Experimental)
n=161 participants at risk
Mammography
|
|---|---|---|
|
Surgical and medical procedures
Surgical and medical proced - Oth spec
|
0.00%
0/158 • Up to 5 years
|
1.9%
3/161 • Number of events 3 • Up to 5 years
|
|
Vascular disorders
Hematoma
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
1.9%
3/161 • Number of events 3 • Up to 5 years
|
|
Vascular disorders
Hot flashes
|
0.00%
0/158 • Up to 5 years
|
1.2%
2/161 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Hypertension
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.62%
1/161 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Hypotension
|
0.00%
0/158 • Up to 5 years
|
1.2%
2/161 • Number of events 2 • Up to 5 years
|
|
Vascular disorders
Lymphedema
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Seroma
|
2.5%
4/158 • Number of events 4 • Up to 5 years
|
2.5%
4/161 • Number of events 4 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Wound complication
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Investigations
Weight loss
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Back pain
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Myalgia
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
1.2%
2/161 • Number of events 2 • Up to 5 years
|
|
Musculoskeletal and connective tissue disorders
Pain in extremity
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Dizziness
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Nervous system disorders
Paresthesia
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Nervous system disorders
Peripheral sensory neuropathy
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Nervous system disorders
Transient ischemic attacks
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Psychiatric disorders
Agitation
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Psychiatric disorders
Anxiety
|
0.00%
0/158 • Up to 5 years
|
1.9%
3/161 • Number of events 3 • Up to 5 years
|
|
Psychiatric disorders
Depression
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Psychiatric disorders
Insomnia
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Reproductive system and breast disorders
Breast pain
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
1.9%
3/161 • Number of events 3 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Cough
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Respiratory, thoracic and mediastinal disorders
Pneumothorax
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Alopecia
|
1.9%
3/158 • Number of events 3 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Skin and subcutaneous tissue disorders
Pain of skin
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
General disorders and administration site conditions
Fatigue
|
2.5%
4/158 • Number of events 4 • Up to 5 years
|
1.9%
3/161 • Number of events 3 • Up to 5 years
|
|
General disorders and administration site conditions
Gen disord and admin site conds-Oth spec
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
General disorders and administration site conditions
Localized edema
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
1.2%
2/161 • Number of events 2 • Up to 5 years
|
|
General disorders and administration site conditions
Pain
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
2.5%
4/161 • Number of events 4 • Up to 5 years
|
|
Infections and infestations
Breast infection
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Infections and infestations
Enterocolitis infectious
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Infections and infestations - Oth spec
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Skin infection
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Upper respiratory infection
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Infections and infestations
Urinary tract infection
|
0.00%
0/158 • Up to 5 years
|
1.2%
2/161 • Number of events 2 • Up to 5 years
|
|
Infections and infestations
Wound infection
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Bruising
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Injury, poisoning and procedural complications
Fall
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Blood and lymphatic system disorders
Anemia
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
1.2%
2/161 • Number of events 2 • Up to 5 years
|
|
Cardiac disorders
Palpitations
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Sinus bradycardia
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Cardiac disorders
Sinus tachycardia
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Endocrine disorders
Hyperthyroidism
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Abdominal pain
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Gastrointestinal disorders
Diarrhea
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Nausea
|
1.3%
2/158 • Number of events 2 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
Gastrointestinal disorders
Oral pain
|
0.63%
1/158 • Number of events 1 • Up to 5 years
|
0.00%
0/161 • Up to 5 years
|
|
Gastrointestinal disorders
Vomiting
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
General disorders and administration site conditions
Chills
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
|
General disorders and administration site conditions
Edema limbs
|
0.00%
0/158 • Up to 5 years
|
0.62%
1/161 • Number of events 1 • Up to 5 years
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place