Lapatinib in Combination With Docetaxel in Patients With HER-2 Positive Advanced or Metastatic Breast Cancer

Sponsor
Centre Georges Francois Leclerc
Study ID
NCT01044485
Phase
PHASE1/PHASE2
Status
Completed

Conditions

Eligibility Criteria

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

Interventions

  • lapatinib — DRUG
    escalation dose from 1250 to 1500 mg in association with docetaxel
  • docetaxel — DRUG
    escalation dose from 75 mg/m2 to 100 mg/m2 in association with lapatinib

Study Details

The objective of this phase I/ II study is therefore to assess the safety and efficacy of lapatinib in combination with docetaxel in patients with advanced cancer. Only patients in first line treatment for metastatic disease should be included in the present study. It is proposed to start with a phase I part evaluating the safety of lapatinib 1250 mg with docetaxel 75 mg/m² without systematic support of growth factors, starting after the completion and data from the 1000 mg lapatinib +75 mg/m² docetaxel dose level in the EORTC (Bonnefoi) study.The objective of the phase II part will confirm the safety and evaluate efficacy of lapatinib in combination with docetaxel.

Key Dates

Start date
Nov 30, 2008
Status verified
Sep 2012
Primary completion
Nov 30, 2011

Study Design

Enrollment
17 participants (actual)
Allocation
NON_RANDOMIZED
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT

Arms

  • Other: lapatinib + docetaxel
    dose level Lapatinib (OD) Docetaxel (q3wks) Systematic Growth factor Minus 0 1250 mg 75 mg/m2 + systematic growth factor support 0, 1250mg 75 mg/m2 No +1 1500mg 75mg/m2 No Minus +1\* 1500mg 75mg/m2 + systematic growth factor support +2 1250mg 100mg/m2 No Minus +2\* + systematic growth factor support +3 1500mg 100mg/m2 No Minus +3\* + systematic growth factor support Apart within the minus dose levels, G-CSF support should be added only as rescue strategy if severe neutropenia occurred during the first cycle of studied dose.Patients will receive 4 cycles of the association. In case of benefit of the treatment, they should continue the treatment with lapatinib until progression.\* patients will be included at level "minus X" only if 2 DLT out of 6 patients based on febrile neutropenia occurred at level "X"

Primary Outcome Measure

To determine the optimal tolerated regimen of lapatinib administered in combination with docetaxel as first-line therapy in patients with metastatic breast cancer [ Time Frame: during first cycle ( each cycle last 3 weeks) ]

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