Trial Outcomes & Findings for An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer (NCT NCT01187381)
NCT ID: NCT01187381
Last Updated: 2017-10-20
Results Overview
Recruitment status
TERMINATED
Target enrollment
250 participants
Primary outcome timeframe
Baseline up to 5 years
Results posted on
2017-10-20
Participant Flow
Participant milestones
| Measure |
Participants With Breast Cancer
Participants with early or metastatic human epidermal growth factor receptor 2 (HER2)-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Overall Study
STARTED
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250
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Overall Study
COMPLETED
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250
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Overall Study
NOT COMPLETED
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0
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Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
An Observational Study of the Mean Duration of Trastuzumab (Herceptin) Treatment in Participants With Early or Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Breast Cancer
Baseline characteristics by cohort
| Measure |
Participants With Breast Cancer
n=250 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Age, Continuous
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51.2600 years
STANDARD_DEVIATION 10.61939 • n=5 Participants
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Sex: Female, Male
Female
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250 Participants
n=5 Participants
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Sex: Female, Male
Male
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0 Participants
n=5 Participants
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PRIMARY outcome
Timeframe: Baseline up to 5 yearsPopulation: Number of participant analyzed=participants with data available for this outcome measure.
Outcome measures
| Measure |
Participants With Breast Cancer
n=246 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Treatment Duration With Trastuzumab in the Routine Clinical Practice
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401.90 Days
Standard Deviation 229.867
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SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: All enrolled participants
Outcome measures
| Measure |
Participants With Breast Cancer
n=250 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Adverse event
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5 percentage of participants
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Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Death
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2 percentage of participants
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Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Progression of the disease
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18 percentage of participants
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Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Administrative reasons
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30 percentage of participants
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Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Doctor's decision
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40 percentage of participants
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Percentage of Participants Who Discontinued Trastuzumab Therapy According to Reasons for Discontinuation
Other Than the Reasons Reported Above
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5 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: Number of participants analyzed=participant with data available for this outcome
As a neoadjuvant therapy, participants received chemotherapy alone, radiotherapy alone, hormonal therapy alone or combination of these therapies. Percentage of participants who received these therapies is reported.
Outcome measures
| Measure |
Participants With Breast Cancer
n=210 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Chemotherapy and Radiotherapy
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28 percentage of participants
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Chemotherapy and Radiotherapy and Hormonal therapy
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28 percentage of participants
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Chemotherapy and Hormonal therapy
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8 percentage of participants
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Radiotherapy and Hormonal therapy
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7 percentage of participants
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Chemotherapy alone
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21 percentage of participants
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Radiotherapy alone
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6 percentage of participants
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Percentage of Participants Who Received Previous Neoadjuvant Therapy
Hormonal therapy alone
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2 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: Number of participants analyzed=participants who were evaluable for this outcome measure
Percentage of participants who underwent different types of surgical procedures for breast cancer are reported. Different types of surgical procedures included: breast-conserving surgery; mastectomy; and other (any other surgical procedure except breast-conserving surgery and mastectomy).
Outcome measures
| Measure |
Participants With Breast Cancer
n=237 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Percentage of Participants Who Had Surgical Procedure for Breast Cancer
Breast-conserving surgery
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21.2 percentage of participants
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Percentage of Participants Who Had Surgical Procedure for Breast Cancer
Mastectomy
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73.2 percentage of participants
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Percentage of Participants Who Had Surgical Procedure for Breast Cancer
Other
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0.4 percentage of participants
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SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: All enrolled participants
Outcome measures
| Measure |
Participants With Breast Cancer
n=250 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Percentage of Participants Who Received Trastuzumab as Adjuvant Therapy of HER2 Positive Breast Cancer
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82 percentage of participants
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SECONDARY outcome
Timeframe: Baseline uo tp 5 yearsPopulation: Number of participants analyzed=participants who presented progression of disease
Progression free survival was defined as the time from first dose of trastuzumab to disease progression as assessed by treating physician. Due to observational nature of the study, there was no specific method of assessment used to define progressive disease. Progressive disease was confirmed by treating physician, based on his/her assessment according to local practice.
Outcome measures
| Measure |
Participants With Breast Cancer
n=44 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Progression Free Survival
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324 days
Interval 84.0 to 1849.0
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SECONDARY outcome
Timeframe: Baseline up to 5 yearsPopulation: Number of participants analyzed=participants who presented disease progression
Outcome measures
| Measure |
Participants With Breast Cancer
n=44 Participants
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Percentage of Participants by the Site of First Disease Progression
Bone
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11 percentage of participants
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Percentage of Participants by the Site of First Disease Progression
Brain
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32 percentage of participants
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Percentage of Participants by the Site of First Disease Progression
Breast
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9 percentage of participants
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Percentage of Participants by the Site of First Disease Progression
Liver
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27 percentage of participants
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Percentage of Participants by the Site of First Disease Progression
Lung
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21 percentage of participants
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Adverse Events
Participants With Breast Cancer
Serious events: 12 serious events
Other events: 17 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Participants With Breast Cancer
n=250 participants at risk
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Cardiac disorders
Cardiac failure chronic
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0.40%
1/250 • Baseline up to 5 years
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Cardiac disorders
Myocarditis
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0.40%
1/250 • Baseline up to 5 years
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General disorders
Chills
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0.40%
1/250 • Baseline up to 5 years
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General disorders
Death
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0.40%
1/250 • Baseline up to 5 years
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Hepatobiliary disorders
Metastases to liver
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0.40%
1/250 • Baseline up to 5 years
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Hepatobiliary disorders
Jaundice
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0.40%
1/250 • Baseline up to 5 years
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Hepatobiliary disorders
Hepatitis viral
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0.40%
1/250 • Baseline up to 5 years
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Investigations
Ejection fraction decreased
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0.80%
2/250 • Baseline up to 5 years
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Musculoskeletal and connective tissue disorders
Craniofacial fracture
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0.40%
1/250 • Baseline up to 5 years
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Nervous system disorders
Transient ischemic attack
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0.40%
1/250 • Baseline up to 5 years
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Reproductive system and breast disorders
Breast cancer metastatic
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0.40%
1/250 • Baseline up to 5 years
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Respiratory, thoracic and mediastinal disorders
Pneumothorax
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0.40%
1/250 • Baseline up to 5 years
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Vascular disorders
Hypertension
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0.40%
1/250 • Baseline up to 5 years
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Other adverse events
| Measure |
Participants With Breast Cancer
n=250 participants at risk
Participants with early or metastatic HER2-positive breast cancer who were receiving treatment with trastuzumab according to local standard of care and in line with the current summary of product characteristics/ local guidelines, were observed (overall observation period: 5 years). Dosing and treatment duration of the trastuzumab were at the discretion of the treating physician.
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Blood and lymphatic system disorders
Leukopenia
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0.80%
2/250 • Baseline up to 5 years
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General disorders
Edema peripheral
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0.40%
1/250 • Baseline up to 5 years
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Immune system disorders
Hypersensitivity
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0.40%
1/250 • Baseline up to 5 years
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Hepatobiliary disorders
Hepatocellular injury
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0.80%
2/250 • Baseline up to 5 years
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Investigations
Ejection fraction decreased
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1.6%
4/250 • Baseline up to 5 years
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Musculoskeletal and connective tissue disorders
Craniofacial fracture
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0.40%
1/250 • Baseline up to 5 years
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Musculoskeletal and connective tissue disorders
Bone pain
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0.40%
1/250 • Baseline up to 5 years
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Nervous system disorders
Dizziness
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0.40%
1/250 • Baseline up to 5 years
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Respiratory, thoracic and mediastinal disorders
Pneumothorax
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0.40%
1/250 • Baseline up to 5 years
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Respiratory, thoracic and mediastinal disorders
Upper respiratory tract infection
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0.40%
1/250 • Baseline up to 5 years
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Respiratory, thoracic and mediastinal disorders
Rhinorrhea
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0.40%
1/250 • Baseline up to 5 years
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Skin and subcutaneous tissue disorders
Erythema
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0.40%
1/250 • Baseline up to 5 years
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Skin and subcutaneous tissue disorders
Rash erythematous
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0.40%
1/250 • Baseline up to 5 years
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Skin and subcutaneous tissue disorders
Herpes zoster
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0.40%
1/250 • Baseline up to 5 years
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Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee The Study being conducted under this Agreement is part of the Overall Study. Investigator is free to publish in reputable journals or to present at professional conferences the results of the Study, but only after the first publication or presentation that involves the Overall Study. The Sponsor may request that Confidential Information be deleted and/or the publication be postponed in order to protect the Sponsor's intellectual property rights.
- Publication restrictions are in place
Restriction type: OTHER