Kailee

PHRR150227-000910

YO28405

2014-CT0201

A Randomized, Multicenter, Open-label Phase III Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine versus the Combination of Trastuzumab plus Docetaxel as First-line Treatment of Patients with HER2‑Positive Progressive or Recurrent Locally Advanced or Metastatic Breast Cancer

This is a Phase III, randomized, multicenter, multinational, two-arm, open-label clinical trial.

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 multimodality therapy, and/or MBC if they have not received prior chemotherapy for their metastatic disease.

Terminated

low likelihood that study will show significant increase in PFS on those subjects treated with trastuzumab emtansine (based on result of the Marianne study)

breast cancer

progression-free survival
overall survivial
1 year survivial rate
overall survivial truncated at 2 years
objective response rate
duration of response

safety outcomes

Terminated

• China
• Malaysia
• Philippines
• South Korea
• Taiwan
• Thailand

Clinical Trial

Unspecified

2014-10-17

0000-00-00

14

Unspecified

study was terminated early

02 Mar 2015

Disease-specific inclusion criteria:
HER2-positive BC, as defined by an IHC test score of 3+ and/or ISH positivity, prospectively confirmed by a Sponsor-designated central laboratory prior to enrollment.  Archival tumor samples obtained from primary and/or metastatic sites are acceptable

Tumor block or eight unstained freshly cut slides must be available for central laboratory HER2 testing

For patients with bilateral BC, HER2-positive status must be demonstrated in both locations or in a metastatic site

Histologically or cytologically confirmed adenocarcinoma of the breast, with locally recurrent or metastatic disease appropriate for chemotherapy.  Patients with locally advanced disease must have recurrent disease or PD that is not amenable to resection with curative intent or for which study therapy is intended to render the disease resectable.  Patients with standard curative options available to them are not eligible
Patients must have measurable and/or non-measurable disease that is evaluable per RECIST v1.1

Interventional

Trastuzumab emtansine

Eligible patients will be randomized in a 2:1 ratio to receive one of two treatments:

Arm A:  Trastuzumab emtansine 3.6 mg/kg IV over 30-90 minutes Q3W

Arm B:  For the first cycle, trastuzumab 8 mg/kg IV plus docetaxel at either 75 mg/m2 or 100 mg/m2 IV.  For the subsequent cycles, trastuzumab 6 mg/kg IV plus docetaxel 75 mg/m2 or 100 mg/m2 IV Q3W 

All study drugs will be administered at in-clinic visits occurring Q3W during the treatment phase.  Cycle length will be defined as 3 weeks unless the next cycle is delayed (i.e., each administration of study treatment will occur on the first day of a new cycle).

None

Randomized

Open Label

Unspecified

Parallel

breast cancer research

Phase III