Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer
Condition: Breast Cancer
MeSH terms: Breast Neoplasms
Intervention: Docetaxel; Pertuzumab; Trastuzumab
Intervention description: Participants will receive docetaxel in line with locally approved Prescribing Information. After Cycle 6 (cycle length = 21 days), continuation of docetaxel treatment will be at the discretion of the investigator. Docetaxel will be administered after pertuzumab and trastuzumab.; Participants will receive pertuzumab at an initial dose of 840 milligrams (mg) as a 60-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 420 mg as a 30 to 60-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.; Participants will receive trastuzumab at an initial dose of 8 milligrams per kilogram (mg/kg) as a 90-minute intravenous infusion on Cycle 1 Day 1 (cycle length = 21 days), followed by every 3 weeks at a dose of 6 mg/kg as a 30 to 90-minute intravenous infusion until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.
Intervention MeSH terms: Docetaxel; Trastuzumab; Pertuzumab
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 52.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No

Summary:

      This is a Phase 4, single-arm, open-label, multicenter study to assess the safety and
      efficacy of pertuzumab in combination with trastuzumab and docetaxel for the treatment of
      participants with human epidermal growth factor receptor 2 (HER2)-positive advanced (locally
      recurrent, unresectable, or metastatic) breast cancer.
    

Eligibility criteria:

        Inclusion Criteria:

          -  For women of childbearing potential and men with partners of childbearing potential,
             agreement to use a highly-effective non-hormonal form of contraception or two
             effective forms of non-hormonal contraception by the participant and/or partner

          -  Histologically or cytologically confirmed and documented adenocarcinoma of the breast
             with metastatic or locally recurrent disease not amenable to curative resection;
             participants with measurable and/or non-measurable disease are eligible

          -  Known and documented HER2-positive

          -  Known and documented LVEF of at least 50 percent (%)

          -  Adequate organ function

          -  A negative serum beta-human chorionic gonadotropin (beta-HCG) test for women of
             childbearing potential (premenopausal, or less than [<] 12 months of amenorrhea
             post-menopause, and women who have not undergone surgical sterilization [absence of
             ovaries and/or uterus]) within 7 days prior to the first dose of study treatment with
             the result available prior to first dosing

        Exclusion Criteria:

          -  Previous systemic non-hormonal anti-cancer therapy for the metastatic or locally
             recurrent disease

          -  Pregnant or lactating women

          -  Current clinical or radiographic evidence of central nervous system (CNS) metastases

          -  Disease progression while receiving or within 12 months of completion of trastuzumab
             and/or lapatinib treatment in the adjuvant or neo-adjuvant setting

          -  History of LVEF decline to below 50% during or after prior trastuzumab adjuvant or
             neo-adjuvant therapy