Breast Cancer Clinical Trial
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
Summary
This two-cohort, open-label, multicenter, phase 2 study will assess the safety and efficacy of pertuzumab given in combination with trastuzumab (Herceptin) and vinorelbine in first line participants with metastatic or locally advanced HER2-positive breast cancer. Participants will receive pertuzumab and trastuzumab administered sequentially as separate intravenous (IV) infusions (followed by vinorelbine) and conventional sequential administration of pertuzumab and trastuzumab in separate infusion bags, followed by vinorelbine.
Eligibility Criteria
Inclusion Criteria:
Histologically or cytologically confirmed and documented adenocarcinoma of the breast with metastatic or locally advanced disease not amenable to curative resection
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 systemic non-hormonal anti-cancer therapy in the metastatic or locally advanced breast cancer setting
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
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There are 80 Locations for this study
Tucson Arizona, 85724, United States
Stanford California, 94305, United States
Denver Colorado, 80220, United States
Hollywood Florida, 33021, United States
Miami Florida, 33136, United States
Plantation Florida, 33324, United States
Marietta Georgia, 30060, United States
Boston Massachusetts, 02215, United States
Morristown New Jersey, 07960, United States
Durham North Carolina, 27710, United States
Columbus Ohio, 43210, United States
Houston Texas, 77090, United States
San Antonio Texas, 78229, United States
Ogden Utah, 84403, United States
Fredericksburg Virginia, 22408, United States
Seattle Washington, 98101, United States
Seattle Washington, 98195, United States
Rio de Janeiro RJ, 20560, Brazil
Barretos SP, 14784, Brazil
Sao Paulo SP, 01308, Brazil
Sao Paulo SP, 01317, Brazil
Sao Paulo SP, 04039, Brazil
Herlev , 2730, Denmark
Herning , 7400, Denmark
København Ø , 2100, Denmark
Odense , 5000, Denmark
Avignon , 84082, France
Bobigny , 93009, France
Caen , 14076, France
La Tronche , 38700, France
Mont-de-marsan , 40024, France
Paris , 75651, France
Paris , 75908, France
Perigueux , 24000, France
Pierre Benite , 69495, France
Plerin , 22190, France
Rouen , 76038, France
Strasbourg , 67065, France
Tours , 37044, France
Villejuif , 94805, France
Dortmund , 44263, Germany
Dresden , 01307, Germany
Frankfurt am Main , 60389, Germany
Freiburg , 79110, Germany
Georgsmarienhütte , 49124, Germany
Goslar , 38642, Germany
Gütersloh , 33332, Germany
Hamburg , 20357, Germany
Heidelberg , 69115, Germany
Kaiserslautern , 67655, Germany
Kassel , 34119, Germany
Köln , 50677, Germany
Lebach , 66822, Germany
Leer , 26789, Germany
Moers , 47441, Germany
München , 80335, Germany
München , 80639, Germany
Neumarkt , 92318, Germany
Ravensburg , 88212, Germany
Wuerselen , 52146, Germany
Bologna Emilia-Romagna, 40138, Italy
Aviano Friuli-Venezia Giulia, 33081, Italy
Roma Lazio, 00189, Italy
Genova Liguria, 16132, Italy
Cremona Lombardia, 26100, Italy
Monza Lombardia, 20900, Italy
Lido Di Camaiore Toscana, 55043, Italy
Pisa Toscana, 56100, Italy
Terni Umbria, 05100, Italy
Negrar Veneto, 37024, Italy
Oviedo Asturias, 33006, Spain
Terrassa Barcelona, 08227, Spain
Santander Cantabria, 39008, Spain
Barbastro Huesca, 22300, Spain
Palma de Mallorca Islas Baleares, 07198, Spain
La Laguna Tenerife, 38320, Spain
Badajoz , 06080, Spain
Madrid , 28223, Spain
Malaga , 29010, Spain
Valencia , 46014, Spain
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