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A Study of Pertuzumab in Combination With Trastuzumab (Herceptin) and a Taxane in First-Line Treatment in Participants With Human Epidermal Growth Factor 2 (HER2)-Positive Advanced Breast Cancer
Cancer Breast Cancer Breast Cancer HER-2 Positive Breast Neoplasms
Basic Details
Sponsor
Hoffmann-La Roche
Phase
Phase 3
Trial Identifier
NCT01572038, MO28047, 2011-005334-20
Condition
Breast Neoplasms
Official Title
A Multicenter, Open-Label, Single-Arm Study of Pertuzumab in Combination With Trastuzumab and a Taxane in First Line Treatment of Patients With HER2-Positive Advanced (Metastatic or Locally Recurrent) Breast Cancer
Study Summary
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.
Eligibility Criteria
All
≥18 Years
No
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
The source of the below information is public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc.. It has been summarised and edited into simpler language. For more information about this clinical study see the For Expert tab on the specific ForPatients page or follow these links to https://clinicaltrials.gov and/or https://euclinicaltrials.eu and/or https://www.isrctn.com.
The information is taken directly from public registry websites such as ClinicalTrials.gov, EuClinicalTrials.eu, ISRCTN.com, etc., and has not been edited.
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For the latest version of this information please go to www.forpatients.roche.com