A Study of Pertuzumab in Combination With Trastuzumab Plus an Aromatase Inhibitor in Participants With Metastatic Human Epidermal Growth Factor Receptor 2 (HER2)-Positive and Hormone Receptor-Positive Advanced Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Pertuzumab; Trastuzumab; Aromatase Inhibitor; Induction Chemotherapy
Intervention description: Participants will receive a loading dose of 840 milligrams (mg) as an intravenous infusion on Day 1 of first treatment cycle, followed by 420 mg on Day 1 or Day 2 of each subsequent 3-week cycle until disease progression or unacceptable toxicity.; Participants will receive a loading dose of 8 milligrams per kilogram (mg/kg) as an intravenous infusion on Day 1 or 2 of first treatment cycle, followed by 6 mg/kg on Day 1 or Day 2 of each subsequent treatment 3-week cycles until disease progression or unacceptable toxicity.; Participants will receive 1 mg anastrozole or 2.5 mg letrozole orally once daily.; Participants receiving induction chemotherapy up to the first 18-24 weeks of the treatment period will receive a taxane (docetaxel every 3 weeks or paclitaxel weekly), administered in line with the respective pertuzumab and/or trastuzumab infusions at the investigator's discretion.
Intervention MeSH terms: Trastuzumab; Pertuzumab; Aromatase Inhibitors
Phase: Phase 2
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: None (Open Label)
Enrollment: 258.0
Sex: Female
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This randomized, open-label, two-arm, multi-center, Phase II study will evaluate the efficacy
      and safety of pertuzumab in combination with trastuzumab plus an aromatase inhibitor (AI) in
      first-line participants with HER2-positive and hormone receptor-positive advanced breast
      cancer. Participants will be randomized to one of two treatment arms; Arm A (pertuzumab in
      combination with trastuzumab plus an AI) or Arm B (trastuzumab plus an AI). Participants may
      also receive induction chemotherapy (a taxane, either docetaxel or paclitaxel) at the
      investigator's discretion in combination with the assigned treatment arm. The anticipated
      time on study treatment is until disease progression, unacceptable toxicity, withdrawal of
      consent, or death whichever occurs first.
    

Eligibility criteria:

        Inclusion Criteria:

          -  Participants with HER2-positive and hormone receptor-positive advanced metastatic or
             locally advanced breast cancer

          -  Post-menopausal status over 1 year

          -  HER2-positive as assessed by local laboratory on primary or metastatic tumor

          -  Hormone-receptor positive defined as estrogen receptor-positive and/or progesterone
             receptor-positive

          -  At least one measurable lesion and/or non-measurable disease evaluable according to
             Response Evaluation Criteria In Solid Tumors Version 1.1

        Exclusion Criteria:

          -  Previous systemic non-hormonal anticancer therapy in the metastatic or locally
             advanced breast cancer setting

          -  Previous treatment with anti-HER2 agents for breast cancer, except trastuzumab and/or
             lapatinib in the neoadjuvant or adjuvant setting

          -  Disease progression while receiving adjuvant trastuzumab and/or lapatinib treatment

          -  History of persistent Grade 2 or higher hematological toxicity according to National
             Cancer Institute-Common Toxicity Criteria Version 4.0

          -  Disease-free interval from completion of adjuvant/neo-adjuvant systemic non-hormonal
             treatment to recurrence of within 6 months

          -  Other malignancies within the last 5 years, except for carcinoma in situ of the cervix
             or basal cell carcinoma

          -  Clinical or radiographic evidence of central nervous system metastases or significant
             cardiovascular disease