Overview

A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine Versus the Combination of Trastuzumab Plus Docetaxel in Patients With HER2-positive Breast Cancer

Status:
Terminated
Trial end date:
2016-01-01
Target enrollment:
0
Participant gender:
All
Summary
This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial to investigate a first-line treatment of participants with human epidermal growth factor receptor-2 (HER2)-positive metastatic breast cancer. The study will enroll patients with HER2-positive, unresectable, locally advanced breast cancer (BC) if they have recurrent disease or progressive disease (PD) despite primary multi-modality therapy, and/or metastatic BC if they have not received prior chemotherapy for their metastatic disease. Eligible participants at up to approximately 40 sites in the Asia-Pacific region will be randomized in a 2:1 ratio to receive trastuzumab emtansine (Arm A) or trastuzumab plus docetaxel (Arm B). All study drugs will be administered at in-clinic visits occurring every three weeks during the treatment phase. Trastuzumab plus docetaxel was chosen as the comparator in the control group (Arm B), as it represents a common first-line treatment option used in this patient population in China and other Asia-Pacific countries.
Phase:
Phase 3
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Hoffmann-La Roche
Treatments:
Ado-Trastuzumab Emtansine
Docetaxel
Maytansine
Trastuzumab
Criteria
Inclusion Criteria:

- Age >/= 18 years

- HER2-positive disease, as defined by an immunohistochemistry test score of 3+ and/or
in situ hybridization positivity, prospectively confirmed by a Sponsor-designated
central laboratory prior to enrollment

- Histologically or cytologically confirmed adenocarcinoma of the breast with locally
recurrent or metastatic disease appropriate for chemotherapy

- Patients must have measurable and/or non-measurable disease that is evaluable per the
Response Evaluation Criteria in Solid Tumors (RECIST) criteria, version 1.1

- Eastern Cooperative Oncology Group (ECOG) Performance Status of 0 or 1

- Adequate organ function

- For women of childbearing potential and men with partners of childbearing potential,
agreement by the patient and/or partner to use two adequate non-hormonal forms of
contraception during treatment and for at least 6 months after the last dose of study
drug

Exclusion Criteria:

- Pregnancy or lactation

- Current severe, uncontrolled systemic disease (e.g., clinically significant
cardiovascular, pulmonary, or metabolic disease; wound healing disorders; ulcers; bone
fractures, except bone fractures because of disease under study)

- Currently known active infection with HIV, hepatitis B virus (HBV), or hepatitis C
virus (HCV)

- Major surgical procedure or significant traumatic injury within approximately 28 days
prior to randomization or anticipation of the need for major surgery during the course
of study treatment

- Current peripheral neuropathy Grade >/= 2 per National Cancer Institute Common
Terminology Criteria for Adverse Events, Version 4.0 (NCI CTCAE, v4.0)

- History of systemic anti-cancer therapy after the diagnosis of metastatic breast
cancer (MBC) or for recurrent locally advanced disease, with the exception of prior
hormonal regimens for recurrent locally advanced disease or MBC

- An interval of < 12 months after the last dose of vinca alkaloid or taxane
chemotherapy (i.e., for treatment of early stage, non-metastatic disease)

- Hormonal therapy < 7 days prior to randomization

- Trastuzumab < 21 days prior to randomization

- Lapatinib
- Prior trastuzumab emtansine therapy

- Treatment with any other anti-cancer therapy/investigational drug (not defined above)
within 21 days prior to randomization

- History of other malignancy within the last 5 years, except for appropriately treated
carcinoma in situ of the cervix, non-melanoma skin carcinoma, Stage I uterine cancer,
or other malignancies with an expected curative outcome

- Current chronic daily treatment with corticosteroids (dose > 10 mg/day
methylprednisone equivalent)

- History of intolerance (including Grade 3 or 4 infusion reaction) or hypersensitivity
to trastuzumab, murine proteins, docetaxel or paclitaxel

- Known hypersensitivity any of the study drugs, including excipients, or any drugs
formulated in polysorbate 80