Pertuzumab and Trastuzumab as Neoadjuvant Treatment in Patients With HER2-Positive Breast Cancer
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ClinicalTrials.gov Identifier: NCT01937117 |
Recruitment Status :
Active, not recruiting
First Posted : September 9, 2013
Results First Posted : April 12, 2019
Last Update Posted : January 25, 2023
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Study Type | Interventional |
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Study Design | Allocation: N/A; Intervention Model: Single Group Assignment; Masking: None (Open Label); Primary Purpose: Treatment |
Condition |
Breast Cancer |
Interventions |
Procedure: Positron emission tomography (PET) Drug: Trastuzumab Drug: Pertuzumab |
Enrollment | 88 |
Recruitment Details | |
Pre-assignment Details |
Arm/Group Title | Trastuzumab and Pertuzumab |
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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 |
Period Title: Overall Study | |
Started | 88 |
Completed | 75 |
Not Completed | 13 |
Reason Not Completed | |
Disease Progression | 7 |
Physician Decision | 4 |
Adverse Event | 2 |
Arm/Group Title | Trastuzumab and Pertuzumab | |
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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 |
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Overall Number of Baseline Participants | 88 | |
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[Not Specified]
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Age, Continuous
Median (Standard Deviation) Unit of measure: Years |
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Number Analyzed | 88 participants | |
58 (12.6) | ||
Sex: Female, Male
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
Female |
88 100.0%
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Male |
0 0.0%
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Ethnicity (NIH/OMB)
Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
Hispanic or Latino |
5 5.7%
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Not Hispanic or Latino |
79 89.8%
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Unknown or Not Reported |
4 4.5%
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Race/Ethnicity, Customized
Measure Type: Count of Participants Unit of measure: Participants |
Number Analyzed | 88 participants |
White |
75 85.2%
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Black or African American |
7 8.0%
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Other |
6 6.8%
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Region of Enrollment
Measure Type: Count of Participants Unit of measure: Participants |
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United States | Number Analyzed | 88 participants |
88 100.0%
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Eastern Cooperative Oncology Group (ECOG) Performance Status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
0 |
76 86.4%
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1 |
12 13.6%
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[1]
Measure Description: The ECOG scale measures performance status, with scores ranging from 0-5; 0= fully active, performs without restriction, 1= can ambulate, but restricted in physically strenuous activity, 2= ambulatory and capable of self-care, but unable to work, active for >50% of waking hours, 3= limited self-care, confined to bed or chair for >50% of waking hours, 4= completely disabled, totally confined to bed/chair, 5= deceased
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Baseline clinical tumor size
[1] Median (Standard Deviation) Unit of measure: Cm |
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Number Analyzed | 88 participants | |
3.7 (2) | ||
[1]
Measure Description: Primary breast tumor size in centimeters (cm)
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Clinical tumor T staging
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
T1 |
0 0.0%
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T2 |
66 75.0%
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T3 |
19 21.6%
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T4 |
3 3.4%
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[1]
Measure Description: T refers to the extent (size) of the tumor and is based off the staging system used for breast cancer is the American Joint Committee on Cancer (AJCC). Staging is as follows: T1= tumor <= 2cm in greatest dimension, T2= tumor >2cm in greatest dimension, T3= tumor >5cm in greatest dimension, and T4= tumor of any size with direct extension to chest wall (T4a) or skin (T4b). A higher number reflects a more progressive stage.
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Baseline clinical nodal status
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
Negative |
45 51.1%
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Positive |
43 48.9%
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[1]
Measure Description: Based from the American Joint Committee on Cancer (AJCC) TNM system, this measures whether participants' cancer has spread to lymph nodes near the breast.
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Clinical tumor N staging
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
N0 |
45 51.1%
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N1 |
38 43.2%
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N2 |
3 3.4%
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N3 |
2 2.3%
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[1]
Measure Description: AJCC staging: N0= no regional lymph node (LN) metastasis ("mets"), N1= mets in movable ipsilateral axillary LN; N2= mets in ipsilateral axillary LNs fixed or matted, or in clinically apparent ipsilateral internal mammary LN without of clinically evident axillary LN mets; N3= mets in ipsilateral infraclavicular LN, or in clinically apparent ipsilateral internal mammary LNs and in the presence of clinically evident axillary LN mets; or mets in ipsilateral supraclavicular LN with or without axillary or internal mammary lymph node involvement. A higher number reflects a greater region of mets.
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Baseline clinical stage
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
Stage I |
0 0.0%
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Stage II |
74 84.1%
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Stage III |
14 15.9%
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Stage IV |
0 0.0%
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[1]
Measure Description: Based on AJCC TNM staging (as described above): earliest stage breast cancers are stage 0 (carcinoma in situ). It then ranges from stage I (1) through IV (4), with a higher stage reflecting worse outcome. Stage I= T1N0M0, Stage II= T0N1M0, T1N1M0, T2N0M0, T2N1M0, T3N0M0, Stage III= T0N2M0, T1N2M0, T2N2M0, T3N1M0, T3N2M0, T4N0M0, T4N1M0, T4N2M0, any TN3M0.
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Tumor Grade
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
Grade 1 |
0 0.0%
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Grade 2 |
22 25.0%
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Grade 3 |
66 75.0%
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[1]
Measure Description: Tumor grade measures how much the cancer cells look like normal cells. Grading is as follows: Grade 1 (well differentiated)= the cells are slower-growing, and look more like normal breast tissue; Grade 2 (moderately differentiated)= the cells are growing at a speed of and look like cells somewhere between grades 1 and 3, Grade 3 (poorly differentiated) = the cells look very different from normal cells and will probably grow and spread faster. A higher grade reflects a worse prognosis.
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Additional neoadjuvant therapy
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
Yes |
25 28.4%
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No |
59 67.0%
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N/A |
4 4.5%
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[1]
Measure Description: Study treatment was pertuzumab and trastuzumab. If required by care team, participants could receive additional treatment, outside of the protocol, prior to surgery.
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Type of Surgery
[1] Measure Type: Count of Participants Unit of measure: Participants |
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Number Analyzed | 88 participants | |
Mastectomy |
51 58.0%
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Breast-conserving therapy |
33 37.5%
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N/A |
4 4.5%
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[1]
Measure Description: Type of surgical intervention received.
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Name/Title: | Vered Stearns |
Organization: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
Phone: | 443-287-6489 |
EMail: | vstearn1@jhmi.edu |
Responsible Party: | Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins |
ClinicalTrials.gov Identifier: | NCT01937117 |
Other Study ID Numbers: |
TBCRC 026 TBCRC026 ( Other Identifier: Translational Breast Cancer Research Consortium (TBCRC) ) NA_00080994 ( Other Identifier: JHMIRB ) |
First Submitted: | September 3, 2013 |
First Posted: | September 9, 2013 |
Results First Submitted: | March 18, 2019 |
Results First Posted: | April 12, 2019 |
Last Update Posted: | January 25, 2023 |