A Study of Pertuzumab and Trastuzumab Subcutaneous (SC) Treatment in Combination With a Taxane in Participants With Human Epidermal Growth Factor Receptor 2 (HER2)-Positive Metastatic Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; Nab-paclitaxel; Paclitaxel; Pertuzumab; Trastuzumab
Intervention description: Dosing regimen to be determined by the investigator, routine clinical practices.; Dosing regimen to be determined by the investigator, routine clinical practices.; Dosing regimen to be determined by the investigator, routine clinical practices.; Pertuzumab will be administered on Day 1 of the first treatment cycle as a loading dose of 840 mg, followed by 420 mg as an IV infusion every 3 weeks.; Trastuzumab will be administered at a fixed dose of 600 mg SC every 3 weeks.
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: 50.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This open-label, multicenter, Phase IIIb study will assess the safety, tolerability and
      efficacy of a combination therapy of intravenous (IV) pertuzumab (Perjeta), trastuzumab
      (Herceptin) SC, and taxane chemotherapy (docetaxel, paclitaxel or nab-paclitaxel) as
      first-line therapy in participants with HER2-positive metastatic breast cancer (mBC). All
      participants will be treated with 3-week cycles of pertuzumab IV (840 milligrams [mg] first
      dose; subsequent doses of 420 mg) and trastuzumab SC (600 milligrams [mg]). The taxane
      treatment regimen will be determined by the investigator. Participants will continue therapy
      until disease progression, unacceptable toxicity, or the participant withdraws consent,
      whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  HER2-positive disease, with an immunohistochemistry score of 3+ or in situ
             hybridization (ISH)-positive on primary tumor or metastatic site

          -  Histologically or cytologically confirmed adenocarcinoma of the breast with metastatic
             disease with at least one measurable lesion and/or non-measurable disease according to
             RECIST Version 1.1

          -  Eastern Cooperative Oncology Group (ECOG) performance status 0-2 for participants who
             will receive paclitaxel or nab-paclitaxel chemotherapy and ECOG 0-1 for participants
             who will receive docetaxel chemotherapy

          -  LVEF of greater than or equal to (>=) 50 percent (%) measured by ECHO or MUGA scan
             before the first doses of pertuzumab and trastuzumab

          -  Previous use of either adjuvant or neoadjuvant anti-HER2 therapy is allowed

          -  Hormonal therapy will be allowed as per institutional guidelines. Hormonal therapy
             cannot be administered in combination with taxane therapy

        Exclusion Criteria:

          -  Previous systemic non-hormonal anticancer therapy for treatment of mBC

          -  History of other cancers. Participants with curatively treated carcinoma in situ of
             the cervix or basal cell carcinoma and participants with other curatively-treated
             cancers who have been disease-free for at least 5 years are eligible. Participants
             with previous ductal carcinoma in situ (DCIS) of the breast are also eligible for the
             study

          -  Pregnant or breastfeeding women. Positive serum pregnancy test in women of
             childbearing potential, premenopausal or less than 12 months of amenorrhea
             post-menopause, within 7 days before the first dose of pertuzumab and trastuzumab

          -  Current peripheral neuropathy of Grade 3 or greater (National Cancer Institute Common
             Terminology Criteria for Adverse Events [NCI CTCAE] Version 4.0)

          -  Radiographic evidence of central nervous system (CNS) metastases as assessed by
             computed tomography (CT) or magnetic resonance imaging (MRI), unless they have been
             treated and have been stable for at least 3 months and do not require ongoing
             corticosteroid treatment

          -  Participants with other concurrent serious diseases that may interfere with planned
             treatment, including severe pulmonary conditions/illness

          -  Inadequate organ function

          -  Serious cardiac illness or medical conditions that would preclude the use of
             trastuzumab

          -  Participants with severe dyspnea at rest or requiring supplementary oxygen therapy

          -  Concurrent enrollment in another clinical study using an investigational anti-cancer
             treatment, within 28 days before the first doses of trastuzumab and pertuzumab