Trial Outcomes & Findings for Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer (NCT NCT01937117)
NCT ID: NCT01937117
Last Updated: 2025-07-01
Results Overview
SULmax is the maximum SUV corrected for lean body mass. Change in SULmax from baseline to Day 15 on FDG PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review. SULmax was measured via spherical volume over the target primary breast cancer tissue.
Recruitment status
ACTIVE_NOT_RECRUITING
Study phase
PHASE2
Target enrollment
88 participants
Primary outcome timeframe
Baseline and Day 15
Results posted on
2025-07-01
Participant Flow
Participant milestones
| Measure |
Trastuzumab and Pertuzumab
Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)
Positron emission tomography (PET): PET will be performed at baseline and on day 15
Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV
Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV
|
|---|---|
|
Overall Study
STARTED
|
88
|
|
Overall Study
COMPLETED
|
75
|
|
Overall Study
NOT COMPLETED
|
13
|
Reasons for withdrawal
| Measure |
Trastuzumab and Pertuzumab
Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)
Positron emission tomography (PET): PET will be performed at baseline and on day 15
Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV
Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV
|
|---|---|
|
Overall Study
Disease Progression
|
7
|
|
Overall Study
Physician Decision
|
4
|
|
Overall Study
Adverse Event
|
2
|
Baseline Characteristics
Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Trastuzumab and Pertuzumab
n=88 Participants
Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)
Positron emission tomography (PET): PET will be performed at baseline and on day 15
Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV
Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV
|
|---|---|
|
Age, Continuous
|
58 years
STANDARD_DEVIATION 12.6 • n=5 Participants
|
|
Sex: Female, Male
Female
|
88 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
5 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
79 Participants
n=5 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
4 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
White
|
75 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Black or African American
|
7 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Other
|
6 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
88 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
0
|
76 Participants
n=5 Participants
|
|
Eastern Cooperative Oncology Group (ECOG) Performance Status
1
|
12 Participants
n=5 Participants
|
|
Baseline clinical tumor size
|
3.7 cm
STANDARD_DEVIATION 2 • n=5 Participants
|
|
Clinical tumor T staging
T1
|
0 Participants
n=5 Participants
|
|
Clinical tumor T staging
T2
|
66 Participants
n=5 Participants
|
|
Clinical tumor T staging
T3
|
19 Participants
n=5 Participants
|
|
Clinical tumor T staging
T4
|
3 Participants
n=5 Participants
|
|
Baseline clinical nodal status
Negative
|
45 Participants
n=5 Participants
|
|
Baseline clinical nodal status
Positive
|
43 Participants
n=5 Participants
|
|
Clinical tumor N staging
N0
|
45 Participants
n=5 Participants
|
|
Clinical tumor N staging
N1
|
38 Participants
n=5 Participants
|
|
Clinical tumor N staging
N2
|
3 Participants
n=5 Participants
|
|
Clinical tumor N staging
N3
|
2 Participants
n=5 Participants
|
|
Baseline clinical stage
Stage I
|
0 Participants
n=5 Participants
|
|
Baseline clinical stage
Stage II
|
74 Participants
n=5 Participants
|
|
Baseline clinical stage
Stage III
|
14 Participants
n=5 Participants
|
|
Baseline clinical stage
Stage IV
|
0 Participants
n=5 Participants
|
|
Tumor Grade
Grade 1
|
0 Participants
n=5 Participants
|
|
Tumor Grade
Grade 2
|
22 Participants
n=5 Participants
|
|
Tumor Grade
Grade 3
|
66 Participants
n=5 Participants
|
|
Additional neoadjuvant therapy
Yes
|
25 Participants
n=5 Participants
|
|
Additional neoadjuvant therapy
No
|
59 Participants
n=5 Participants
|
|
Additional neoadjuvant therapy
N/A
|
4 Participants
n=5 Participants
|
|
Type of Surgery
Mastectomy
|
51 Participants
n=5 Participants
|
|
Type of Surgery
Breast-conserving therapy
|
33 Participants
n=5 Participants
|
|
Type of Surgery
N/A
|
4 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: Baseline and Day 15Population: Data was evaluable in only 83/88 participants.
SULmax is the maximum SUV corrected for lean body mass. Change in SULmax from baseline to Day 15 on FDG PET in correlation with pathological complete response (pCR) in patients treated with preoperative pertuzumab/trastuzumab. pCR was defined as no viable invasive cancer in breast and axilla by local pathology review. SULmax was measured via spherical volume over the target primary breast cancer tissue.
Outcome measures
| Measure |
Trastuzumab and Pertuzumab
n=83 Participants
Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)
Positron emission tomography (PET): PET will be performed at baseline and on day 15
Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV
Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV
|
|---|---|
|
Percent Change in Standardized Uptake Value (SUV) as Measured by SULmax on [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)
pCR
|
61.9 percent reduction in SULmax
Standard Deviation 22.3
|
|
Percent Change in Standardized Uptake Value (SUV) as Measured by SULmax on [18F]Fluorodeoxyglucose (FDG) Positron Emission Tomography (PET)
no pCR
|
34.3 percent reduction in SULmax
Standard Deviation 31.9
|
SECONDARY outcome
Timeframe: 3 yearsTo correlate PIK3CA mutation status and other genomic alterations (mutations/somatic rearrangements) qualitatively and quantitatively in plasma tumor DNA (ptDNA) with pCR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsTo correlate PI3K pathway activation (e.g. PTEN low and/or PIK3CA mutation, human epidermal growth factor receptor (HER) 1-4 expression and/or phosphorylation) in tumor samples and pCR
Outcome measures
Outcome data not reported
SECONDARY outcome
Timeframe: 3 yearsTo correlate baseline and change (day 15) in Ki67 with pCR
Outcome measures
Outcome data not reported
Adverse Events
Trastuzumab and Pertuzumab
Serious events: 2 serious events
Other events: 88 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Trastuzumab and Pertuzumab
n=88 participants at risk
Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)
Positron emission tomography (PET): PET will be performed at baseline and on day 15
Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV
Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV
|
|---|---|
|
Injury, poisoning and procedural complications
Sepsis
|
1.1%
1/88 • Number of events 2 • Up to 16 weeks
|
|
Gastrointestinal disorders
Enterocolitis
|
1.1%
1/88 • Number of events 1 • Up to 16 weeks
|
Other adverse events
| Measure |
Trastuzumab and Pertuzumab
n=88 participants at risk
Preoperative treatment with trastuzumab (8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV) and pertuzumab (840 mg as a loading dose, then 420 mg every 3 weeks, IV) every 3 weeks for 4 doses (total 12 weeks or 3 months of treatment) as assessed by Positron Emission Tomography (PET)
Positron emission tomography (PET): PET will be performed at baseline and on day 15
Trastuzumab: 8 mg/kg loading dose, then 6 mg/kg every 3 weeks, IV
Pertuzumab: 840 mg as a loading dose, then 420 mg every 3 weeks, IV
|
|---|---|
|
Skin and subcutaneous tissue disorders
Rash (NOS)
|
19.3%
17/88 • Number of events 17 • Up to 16 weeks
|
|
Gastrointestinal disorders
Diarrhea
|
90.9%
80/88 • Number of events 80 • Up to 16 weeks
|
|
Gastrointestinal disorders
Dyspepsia
|
5.7%
5/88 • Number of events 5 • Up to 16 weeks
|
|
Gastrointestinal disorders
Mucositis
|
13.6%
12/88 • Number of events 12 • Up to 16 weeks
|
|
Gastrointestinal disorders
Nausea
|
27.3%
24/88 • Number of events 24 • Up to 16 weeks
|
|
General disorders
Fatigue
|
34.1%
30/88 • Number of events 30 • Up to 16 weeks
|
|
Nervous system disorders
Headache
|
14.8%
13/88 • Number of events 13 • Up to 16 weeks
|
|
General disorders
Chills
|
11.4%
10/88 • Number of events 10 • Up to 16 weeks
|
|
Nervous system disorders
Dysgeusia
|
6.8%
6/88 • Number of events 6 • Up to 16 weeks
|
|
Skin and subcutaneous tissue disorders
Dry skin
|
5.7%
5/88 • Number of events 5 • Up to 16 weeks
|
Additional Information
Jenna Canzoniero, MD
Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins
Phone: 410-955-8983
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place