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Sponsor: Hoffmann-La Roche
Conditions: Breast Neoplasms
Interventions: Docetaxel, Nab-paclitaxel, Paclitaxel, Pertuzumab, Trastuzumab
Countries: Algeria, Argentina, Australia, Austria, Belgium, Brazil, Canada, China
This multicenter, open-label, single-arm, Phase IIIb study will evaluate the safety and tolerability of pertuzumab in combination with trastuzumab (Herceptin) and a taxane (docetaxel, paclitaxel or nab-paclitaxel) in first-line treatment in participants with metastatic or locally recurrent HER2-positive breast cancer. Participants will receive pertuzumab intravenously (IV) and trastuzumab (Herceptin) IV plus a taxane in cycles of 3 weeks each until predefined study end, unacceptable toxicity, withdrawal of consent, disease progression, or death, whichever occurs first.
Sex: ALL
Age: 18 Years to —
Healthy volunteers: No
Study type: INTERVENTIONAL
Inclusion Criteria: * Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic or locally recurrent disease not amenable to curative resection * HER2-positive breast cancer * Eastern cooperative Oncology Group (ECOG) performance status 0, 1 or 2 * LVEF of at least 50 percent (%) Exclusion Criteria: * Previous systemic non-hormonal anti-cancer therapy for metastatic or locally recurrent disease * Disease-free interval from completion of adjuvant or neoadjuvant systemic non-hormonal treatment to recurrence less than or equal to (\</=) 6 months * Previous approved or investigative anti-HER2 agents in any breast cancer treatment setting, except for trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * Disease progression while receiving trastuzumab and/or lapatinib in the adjuvant or neoadjuvant setting * History of persistent Grade 2 or higher (National Cancer Institute Common Toxicity Criteria \[NCI-CTC\], Version 4.0) hematological toxicity resulting from previous adjuvant or neoadjuvant therapy * Central nervous system (CNS) metastases * Current peripheral neuropathy of Grade 3 or greater (NCI-CTC, version 4.0) * History of other malignancy within the last 5 years prior to first study drug administration, except for carcinoma in situ of the cervix or basal cell carcinoma * Inadequate bone marrow, liver or renal function * Uncontrolled hypertension * Hepatitis B, hepatitis C or Human Immunodeficiency Virus (HIV) infection
- Algiers, Algeria
- La Rioja, Argentina
- Rosario, Argentina
- Canberra, Australian Capital Territory, Australia
- Camperdown, New South Wales, Australia
- Chermside, Queensland, Australia
- South Brisbane, Queensland, Australia
- Melbourne, Victoria, Australia
- Parkville, Victoria, Australia
- Graz, Austria
- Graz, Austria
- Innsbruck, Austria
- Linz, Austria
- Salzburg, Austria
- Steyr, Austria
- Vienna, Austria
- Vienna, Austria
- Brussels, Belgium
- Edegem, Belgium
- Ghent, Belgium
- Leuven, Belgium
- Liège, Belgium
- Rio de Janeiro, Rio de Janeiro, Brazil
- Porto Alegre, Rio Grande do Sul, Brazil
- Jaú, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- São Paulo, São Paulo, Brazil
- Edmonton, Alberta, Canada
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