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.

View Eligibility Criteria

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

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

213

Study ID:

NCT01565083

Recruitment Status:

Completed

Sponsor:

Hoffmann-La Roche

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There are 80 Locations for this study

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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

How clear is this clinincal trial information?

Study is for people with:

Breast Cancer

Phase:

Phase 2

Estimated Enrollment:

213

Study ID:

NCT01565083

Recruitment Status:

Completed

Sponsor:


Hoffmann-La Roche

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