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
Condition: Breast Neoplasms
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; Nab-paclitaxel; Paclitaxel; Pertuzumab; Trastuzumab
Intervention description: Participants may receive 'docetaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.; Participants may receive 'nab-paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.; Participants may receive 'paclitaxel' taxane chemotherapy as per investigator's choice, administered in line with the respective product information and/or recognized clinical practice guidelines.; Participants will receive pertuzumab 840 milligrams (mg) IV on Day 1 or Day 2 of Cycle 1, followed by 420 mg IV on Day 1 or Day 2 of each subsequent 3-week cycle.; Participants will receive trastuzumab (Herceptin) 8 milligrams per kilogram (mg/kg) IV on Day 1 or Day 2 of Cycle 1, followed by 6 mg/kg IV on Day 1 or Day 2 of each subsequent 3-week cycle, administered in line with the respective product Information and/or recognized clinical practice guidelines.
Intervention MeSH terms: Paclitaxel; Docetaxel; Albumin-Bound Paclitaxel; Trastuzumab; Pertuzumab
Phase: Phase 3
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 1436.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

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:

        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