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

• Status: Completed
• Trial end date: 2019-09-20
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Hoffmann-La Roche
• Treatments: Albumin-Bound Paclitaxel; Docetaxel; Paclitaxel; Pertuzumab; Taxane; Trastuzumab

Criteria

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 (
• 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