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

Roche

Status and phase: Completed; Phase 4

Conditions: Breast Cancer

Treatments: Drug: Pertuzumab; Drug: Docetaxel; Drug: Trastuzumab

Study type: Interventional

Funder types: Industry

Identifiers

NCT02445586

ML29282

Details and patient eligibility

About

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.

Enrollment: 52 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

---

52 participants in 1 patient group

Pertuzumab in Combination with Trastuzumab and Docetaxel

Experimental group

Description:

Participants will receive pertuzumab in combination with trastuzumab and docetaxel every 3 weeks until disease progression, unacceptable toxicity, withdrawal of consent or death, whichever occurs first.

Treatment:

Drug: Trastuzumab

Drug: Docetaxel

Drug: Pertuzumab