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Safety Study of Pertuzumab (in Combination With Trastuzumab and Docetaxel) in Indian Participants With Breast Cancer

CompletedPhase 4

Sponsor: Hoffmann-La Roche

Conditions: Breast Cancer

Interventions: Docetaxel, Pertuzumab, Trastuzumab

Countries: India

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 overview

Sex: ALL

Age: 18 Years to —

Healthy volunteers: No

Study type: INTERVENTIONAL

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

Locations (9)

Mumbai, Maharashtra, India
Mumbai, Maharashtra, India
Pune, Maharashtra, India
New Delhi, National Capital Territory of Delhi, India
Vellore, Tamil Nadu, India
Hyderabad, Telangana, India
Kolkata, West Bengal, India
Bangalore, India
Delhi, India