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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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ClinicalTrials.gov |
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Last refreshed on:
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19 October 2017 |
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Main ID: |
NCT00976989 |
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Date of registration:
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14/09/2009 |
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Prospective Registration:
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Yes |
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Primary sponsor: |
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Public title:
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A Study of Pertuzumab in Combination With Herceptin and Chemotherapy in Participants With HER2-Positive Breast Cancer
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Scientific title:
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A Randomised, Multicentre, Multinational Phase II Study to Evaluate Pertuzumab in Combination With Trastuzumab, Given Either Concomitantly or Sequentially With Standard Anthracycline-based Chemotherapy or Concomitantly With a Non-anthracycline-based Chemotherapy Regimen, as Neoadjuvant Therapy for Patients With Locally Advanced, Inflammatory or Early Stage HER2-positive Breast Cancer |
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Date of first enrolment:
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November 2009 |
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Target sample size:
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225 |
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Recruitment status: |
Completed |
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URL:
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https://clinicaltrials.gov/show/NCT00976989 |
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Study type:
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Interventional |
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Study design:
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Phase:
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Phase 2
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Countries of recruitment
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Bahamas
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Bosnia and Herzegovina
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Brazil
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Canada
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Croatia
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Germany
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Greece
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Italy
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Korea, Republic of
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Mexico
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New Zealand
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Portugal
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Romania
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Serbia
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South Africa
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Spain
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Sweden
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Switzerland
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Taiwan
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United Kingdom
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Contacts
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Name:
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Clinical Trials |
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Address:
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Telephone:
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Email:
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Affiliation:
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Hoffmann-La Roche |
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Key inclusion & exclusion criteria
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Inclusion Criteria:
- female participants, age >/=18 years
- advanced, inflammatory or early stage unilateral invasive breast cancer
- HER2-positive breast cancer
- baseline left ventricular ejection fraction (LVEF) >/=55%
Exclusion Criteria:
- metastatic disease (Stage IV) or bilateral breast cancer
- previous anticancer therapy or radiotherapy for any malignancy
- other malignancy, except for carcinoma in situ of the cervix, or basal cell carcinoma
- clinically relevant cardiovascular disease
- current chronic treatment with corticosteroids of >10mg methylprednisolone or
equivalent
Age minimum:
18 Years
Age maximum:
N/A
Gender:
Female
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Health Condition(s) or Problem(s) studied
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Breast Cancer
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Intervention(s)
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Drug: Docetaxel
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Drug: FEC
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Drug: TCH
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Drug: Trastuzumab
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Drug: Pertuzumab
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Primary Outcome(s)
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Safety: Percentage of Participants With Symptomatic Cardiac Events as Assessed by the Investigator
[Time Frame: From baseline up to approximately 3.5 years]
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Safety: Percentage of Participants With Left Ventricular Ejection Fraction (LVEF) Decline During Pre-operative (Neoadjuvant) Period
[Time Frame: From baseline up to approximately 18 weeks]
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Secondary Outcome(s)
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Safety: Percentage of Participants With Asymptomatic Left Ventricular Ejection Fraction (LVEF) Events
[Time Frame: From baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)]
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Efficacy: Clinical Response Rate
[Time Frame: During each 3-week cycle of 6 total cycles: up to 18 weeks]
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Efficacy: Percentage of Participants Achieving Breast Conserving Surgery
[Time Frame: At approximately 18 weeks]
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Efficacy: Percentage of Participants With Complete Pathological Response (pCR)
[Time Frame: At surgery, after 18 weeks (6 cycles) of treatment]
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Efficacy: Percentage of Participants Without a Progression-Free Survival (PFS) Event
[Time Frame: From baseline to end of study up to 5 years]
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Efficacy: Percentage of Participants Without an Overall Survival (OS) Event
[Time Frame: From baseline to end of study up to 5 years]
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Safety: Maximum Decrease in Left Ventricular Ejection Fraction (LVEF) Measures
[Time Frame: From baseline up to approximately 3.5 years]
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Safety: Percentage of Participants With Cardiac Symptoms Associated With Symptomatic Left Ventricular Systolic Dysfunction (LVSD)
[Time Frame: From Baseline to end of Neoadjuvant Period (up to 18 weeks), Adjuvant Period (up to 1.5 years), Follow-up Period (up to 3.5 years)]
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Efficacy: Percentage of Participants Without a Disease-Free Survival (DFS) Event
[Time Frame: From baseline to end of study up to 5 years]
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Efficacy: Time to Clinical Response
[Time Frame: Up to 18 weeks]
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Secondary ID(s)
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2009-012019-17
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BO22280
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Source(s) of Monetary Support
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Please refer to primary and secondary sponsors
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