Trastuzumab or Lapatinib Ditosylate in Treating Women With Early Breast Cancer

Sponsor
Institute of Cancer Research, United Kingdom
Study ID
NCT01104571
Phase
PHASE3
Status
Unknown

Conditions

Eligibility Criteria

Sex
FEMALE
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • trastuzumab — BIOLOGICAL
    Trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery
  • lapatinib ditosylate — DRUG
    Part 1: Lapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery. Part 2: Lapatinib 1000mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery.
  • laboratory biomarker analysis — OTHER
  • adjuvant therapy — PROCEDURE
  • neoadjuvant therapy — PROCEDURE
  • therapeutic conventional surgery — PROCEDURE
    therapeutic conventional surgery

Study Details

RATIONALE: Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Lapatinib ditosylate may stop the growth of tumor cells by blocking some of the enzymes needed for cell growth. It is not yet known whether trastuzumab or lapatinib ditosylate is more effective in treating women with early breast cancer. Update June 2013: Since the initial development of EPHOS-B in 2007 more evidence in relation to safety and efficacy of anti-HER2 therapies are now available, and in particular, a growing body of evidence that combinations of two anti-HER2 therapies are more effective than monotherapies. Therefore this study has been amended (PART 2) to a 1:1:2 ratio to control, perioperative trastuzumab or the combination of lapatinib and trastuzumab. PURPOSE: This randomized phase III trial is studying trastuzumab to see how well it works compared with lapatinib ditosylate (and in since June 2013 - compared with a combination of lapatinib and trastuzumab) in treating women with early breast cancer.

Key Dates

Start date
Apr 30, 2010
Status verified
Feb 2018
Primary completion
Aug 30, 2017
Completion
Sep 30, 2025

Study Design

Enrollment
257 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Other: Part 1: Control
    No peri-operative therapy given
  • Experimental: Part 1: Trastuzumab
    Trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery.
  • Experimental: Part 1: lapatinib
    Lapatinib 1500mg/day p.o. continuously for 28 days. Should start 11 days (+2 or -1 day) before the scheduled surgery
  • Other: Part 2: Control
    No peri-operative therapy
  • Experimental: Part 2: Trastuzumab
    Trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery.
  • Experimental: Part 2: lapatinib-trastuzumab combination
    Lapatinib 1000mg/day p.o. continuously for 28 days, in combination with trastuzumab 6mg/kg iv given on days 1 \& 8 pre-surgery \& one dose of 2mg/kg iv between days 15-19 post surgery. Both drugs should start 11 days (+2 or -1 day) before the scheduled surgery.

Primary Outcome Measure

Increase in apoptosis, by change in the tumor (morphological apoptosis and activated caspase 3) measured at diagnosis and at surgery (biological phase) [ Time Frame: 10-13 days ]

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