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 (PERUSE)

Roche

Status and phase: Completed; Phase 3

Conditions: Breast Neoplasms

Treatments: Drug: Pertuzumab; Drug: Trastuzumab; Drug: Docetaxel; Drug: Nab-paclitaxel; Drug: Paclitaxel

Study type: Interventional

Funder types: Industry

Identifiers

NCT01572038

2011-005334-20 (EudraCT Number)

MO28047

Details and patient eligibility

About

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.

Enrollment: 1,436 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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1,436 participants in 1 patient group

Pertuzumab + Trastuzumab + Taxane

Experimental group

Description:

Participants will receive pertuzumab 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. Taxane chemotherapy can be either docetaxel, paclitaxel or nab-paclitaxel as per investigator's choice.

Treatment:

Drug: Trastuzumab

Drug: Nab-paclitaxel

Drug: Pertuzumab

Drug: Paclitaxel

Drug: Docetaxel