A Study to Assess Efficacy and Safety of Pertuzumab Given in Combination With Trastuzumab and Vinorelbine in Participants With Metastatic or Locally Advanced Human Epidermal Growth Factor Receptor (HER) 2-Positive Breast Cancer
NCT ID: NCT01565083
Last Updated: 2016-11-22
Study Results
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View full resultsBasic Information
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COMPLETED
PHASE2
213 participants
INTERVENTIONAL
2012-04-30
2015-10-31
Brief Summary
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Detailed Description
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Conditions
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Study Design
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NON_RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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Pertuzumab + Trastuzumab + Vinorelbine: Separate Infusion
Pertuzumab will be administered as IV infusion on Day 1 of the first treatment cycle (1 cycle = 21 days) as a loading dose of 840 milligrams (mg), followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab will be administered as IV infusion on Day 2 of the first treatment cycle as a loading dose of 8 mg per kilogram (mg/kg), followed by 6 mg/kg on Day 2 of each subsequent cycle. Vinorelbine IV infusion (will be administered after trastuzumab) on Day 2 and Day 9 of the first treatment cycle at a dose of 25 mg per meter-squared (mg/m\^2) followed by 30-35 mg/m\^2 on Day 2 and Day 9 of each subsequent cycle. Pertuzumab and trastuzumab will be administered sequentially in separate infusion bags, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab
Loading dose of 840 mg on Day 1 of first 21-day cycle, followed by 420 mg on Day 1 of each subsequent cycle.
Trastuzumab
Loading dose of 8 mg/kg on Day 1 of first 21-day cycle, followed by 6 mg/kg on Day 1 or 2 of each subsequent cycle.
Vinorelbine
A dose of 25 mg/m\^2 followed by 30-35 mg/m\^2 on Days 2 and 9 of the first 21-day cycle and on Days 1 and 8 (or Days 2 and 9) of each subsequent cycle.
Pertuzumab + Trastuzumab + Vinorelbine: Single Infusion
Pertuzumab will be administered as IV infusion on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg on Day 1 of each subsequent cycle. Trastuzumab will be administered as IV infusion on Day 2 of the first treatment cycle as a loading dose of 8 mg/kg, followed by 6 mg/kg on Day 1 of each subsequent cycle. Vinorelbine IV infusion on Day 2 and Day 9 of the first treatment cycle at a dose of 25 mg/m\^2 followed by 30-35 mg/m\^2 on Day 1 and Day 8 of each subsequent cycle. If administration of all 3 drugs is well tolerated in Cycle 1, then on Day 1 of each subsequent cycle, pertuzumab 420 mg and trastuzumab 6 mg/kg will be administered in a single infusion bag, followed by vinorelbine until disease progression, unacceptable toxicity, withdrawal of consent, death, or predefined study end (up to 47 cycles).
Pertuzumab
Loading dose of 840 mg on Day 1 of first 21-day cycle, followed by 420 mg on Day 1 of each subsequent cycle.
Trastuzumab
Loading dose of 8 mg/kg on Day 1 of first 21-day cycle, followed by 6 mg/kg on Day 1 or 2 of each subsequent cycle.
Vinorelbine
A dose of 25 mg/m\^2 followed by 30-35 mg/m\^2 on Days 2 and 9 of the first 21-day cycle and on Days 1 and 8 (or Days 2 and 9) of each subsequent cycle.
Interventions
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Pertuzumab
Loading dose of 840 mg on Day 1 of first 21-day cycle, followed by 420 mg on Day 1 of each subsequent cycle.
Trastuzumab
Loading dose of 8 mg/kg on Day 1 of first 21-day cycle, followed by 6 mg/kg on Day 1 or 2 of each subsequent cycle.
Vinorelbine
A dose of 25 mg/m\^2 followed by 30-35 mg/m\^2 on Days 2 and 9 of the first 21-day cycle and on Days 1 and 8 (or Days 2 and 9) of each subsequent cycle.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* HER2-positive as assessed by local laboratory on primary or metastatic tumor
* At least one measurable lesion and/or non-measurable disease evaluable according to RECIST v1.1 criteria
* Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1
* Left ventricular ejection fraction (LVEF) of at least 55%
* Life expectancy of at least 12 weeks
Exclusion Criteria
* Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting
* Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrent disease of less than 6 months
* History of persistent Grade 2 or higher (National Cancer Institute Common Terminology Criteria \[NCI-CTC\], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy
* Radiographic evidence of central nervous system metastases that are not well controlled with local therapy (irradiation or surgery)
* Current peripheral neuropathy of NCI-CTC, version 4.0 Grade 3 or greater
* History of other malignancy within the last 5 years, except for carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage 1 uterine cancer, or cancers with a similar curative outcome as those mentioned above
* Serious uncontrolled concomitant disease that would contraindicate the use of any of the investigational drugs used in this study or would put the participants at high risk for treatment-related complications
* Inadequate hematologic, liver, or renal function
* Uncontrolled hypertension or clinically significant cardiovascular disease
* Hepatitis B, hepatitis C, or human immunodeficiency virus (HIV) infection
* Current chronic daily treatment with corticosteroids (\>/= 10 mg/day methylprednisolone or equivalent), excluding inhaled steroids
18 Years
ALL
No
Sponsors
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Hoffmann-La Roche
INDUSTRY
Responsible Party
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Principal Investigators
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Clinical Trials
Role: STUDY_DIRECTOR
Hoffmann-La Roche
Locations
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Tucson, Arizona, United States
Stanford, California, United States
Denver, Colorado, United States
Hollywood, Florida, United States
Miami, Florida, United States
Plantation, Florida, United States
Marietta, Georgia, United States
Boston, Massachusetts, United States
Morristown, New Jersey, United States
Durham, North Carolina, United States
Columbus, Ohio, United States
Houston, Texas, United States
San Antonio, Texas, United States
Ogden, Utah, United States
Fredericksburg, Virginia, United States
Seattle, Washington, United States
Seattle, Washington, United States
Rio de Janeiro, Rio de Janeiro, Brazil
Barretos, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
São Paulo, São Paulo, Brazil
Herlev, , Denmark
Herning, , Denmark
København Ø, , Denmark
Odense, , Denmark
Avignon, , France
Bobigny, , France
Caen, , France
La Tronche, , France
Mont-de-Marsan, , France
Paris, , France
Paris, , France
Périgueux, , France
Pierre-Bénite, , France
Plérin, , France
Rouen, , France
Strasbourg, , France
Tours, , France
Villejuif, , France
Cologne, , Germany
Dortmund, , Germany
Dresden, , Germany
Frankfurt am Main, , Germany
Freiburg im Breisgau, , Germany
Georgsmarienhütte, , Germany
Goslar, , Germany
Gütersloh, , Germany
Hamburg, , Germany
Heidelberg, , Germany
Kaiserslautern, , Germany
Kassel, , Germany
Lebach, , Germany
Leer, , Germany
Moers, , Germany
München, , Germany
München, , Germany
Neumarkt, , Germany
Ravensburg, , Germany
Würselen, , Germany
Bologna, Emilia-Romagna, Italy
Aviano, Friuli Venezia Giulia, Italy
Rome, Lazio, Italy
Genoa, Liguria, Italy
Cremona, Lombardy, Italy
Monza, Lombardy, Italy
Lido di Camaiore, Tuscany, Italy
Pisa, Tuscany, Italy
Terni, Umbria, Italy
Negrar, Veneto, Italy
Badajoz, Badajoz, Spain
Palma de Mallorca, Balearic Islands, Spain
Terrassa, Barcelona, Spain
Santander, Cantabria, Spain
Barbastro, Huesca, Spain
Madrid, Madrid, Spain
Málaga, Malaga, Spain
Oviedo, Principality of Asturias, Spain
San Cristóbal de La Laguna, Tenerife, Spain
Valencia, Valencia, Spain
Countries
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References
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Perez EA, Lopez-Vega JM, Petit T, Zamagni C, Easton V, Kamber J, Restuccia E, Andersson M. Safety and efficacy of vinorelbine in combination with pertuzumab and trastuzumab for first-line treatment of patients with HER2-positive locally advanced or metastatic breast cancer: VELVET Cohort 1 final results. Breast Cancer Res. 2016 Dec 13;18(1):126. doi: 10.1186/s13058-016-0773-6.
Other Identifiers
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2011-003308-18
Identifier Type: EUDRACT_NUMBER
Identifier Source: secondary_id
MO27782
Identifier Type: -
Identifier Source: org_study_id