Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer

NCT ID: NCT00842998

Last Updated: 2009-06-26

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: PHASE2
• Total Enrollment: 120 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-02-28
• Study Completion Date: 2011-12-31

Brief Summary

This study will evaluate the activity of single agent trastuzumab or lapatinib in patients not previously treated for HER-2 positive (FISH positive) metastatic breast cancer. A companion biological study will assess factors correlated with sensitivity or resistance to either one of the compounds

Conditions

Metastatic Breast Cancer

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

1 - Trastuzumab

Day1 Week1: 8 mg/kg iv in 90 min. Following 1st week: 2 mg/kg once/weekly for 8 weeks

Group Type: EXPERIMENTAL

Trastuzumab or Lapatinib

Intervention Type: DRUG

Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally

2 - Lapatinib

1500 mg/die orally

Group Type: EXPERIMENTAL

Trastuzumab or Lapatinib

Intervention Type: DRUG

Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally

Interventions

Trastuzumab or Lapatinib

Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• Women aged 18-75 years
• Histologically or cytologically confirmed metastatic disease.
• HER2-Overexpression proven by Fluorescence in Situ Hybridization (FISH).
• Availability of paraffin-embedded block of either primitive tumor and/or biopsy of metastases.
• No prior chemotherapy for metastatic or locally advanced disease. Patients with hormone receptor (oestrogen and/or progesterone) positive breast cancer can be eligible provided that they had received only ONE line of hormonal therapy for metastatic disease.
• For patients undergoing hormonal therapy for metastatic disease, disease progression must be confirmed according to RECIST criteria.
• At least 20% increase in the sum of longest diameters, OR
• Evidence of new metastatic lesions or progression of pre-existing non-target lesions.
• Presence of at least one monodimensionally measurable lesion. Patients without clinically or radiologically proven evidence of disease are not eligible.
• Patients with exclusively skin disease are eligible, provided that the disease evolution under treatment can be photographically documented.
• Patients with involvement of NCS, besides presence of measurable lesions, are eligible provided that:

• Brain lesion/s has/have been radically resected;
• Brain lesion/s has/have obtained complete remission following radiation therapy. Complete remission must be documented by TC or RMN.
• At least 4-week interval from end of radiotherapy, hormono- or immunotherapy and enrollment in this study.
• ECOG PS </= 2 and life expectancy of at least 6 months.
• Liver metastases involving < 30% of liver volume.
• Adequate hematopoietic, liver and renal function
• Written informed consent.
• Patients with childbearing potential must have negative pregnancy test and must use adequate contraceptive measures during treatment.
• Prior treatment with Trastuzumab as adjuvant therapy is permitted provided that it was completed at least 12 months prior enrollment in this study.

Exclusion Criteria

• Prior chemotherapy for metastatic disease.
• Active pregnancy or breastfeeding.
• Previous treatment with Lapatinib.
• Previous therapy with mono- or policlonal antibodies for metastatic disease.
• Patients with bone involvement or pleural effusion/ascites as unique localization of disease.
• Patients with dyspnea due to presence of disease (lymphangitis) or requiring oxygen therapy.
• Patients with clinically evident hearth disease and/or active infectious diseases.
• Patients with not resected or not irradiated brain and/or leptomeningeal metastases.
• Prior or actual concurrent neoplasms, with the exception of adequately treated carcinoma della cervice uterina and basal cell or squamocellular carcinoma of the skin.
• Patients with uncontrolled serious illnesses that may compromise the compliance of the patient to the treatment.
• Previous allergic reactions towards any excipient in the composition of Trastuzumab or Lapatinib.
• Use of any experimental drug within 4 weeks prior initiation of study treatment.
• Women with childbearing potential who refuse to use adequate contraceptive measures.
• Patients unable to give written informed consent or are not compliant with treatment.
• Patients with great tumor involvement (> 30% dof hepatic volume, etc).

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: No

Sponsors

Azienda Ospedaliera Ordine Mauriziano di Torino

OTHER

Sponsor Role: lead

Responsible Party

I.R.C.C. - A.O. Ordine Mauriziano di Torino

Principal Investigators

Massimo Aglietta, Full Professor, MD

Role: STUDY_CHAIR

University of Turin Medical School at AO Ordine Mauriziano di Torino

Filippo Montemurro, MD

Role: PRINCIPAL_INVESTIGATOR

AO Ordine Mauriziano di Torino

Locations

U.O. Oncologia Medica - Ospedale San Luigi

Orbassano, Torino, Italy

Site Status: ACTIVE_NOT_RECRUITING

Institute for Cancer Research and Treatment (I.R.C.C.)

Candiolo , Torino, , Italy

Site Status: RECRUITING

U.O. Oncologia Medica

Cuneo, , Italy

Site Status: ACTIVE_NOT_RECRUITING

U.O. Oncologia Medica - COES Molinette

Torino, , Italy

Site Status: ACTIVE_NOT_RECRUITING

Countries

Italy

Central Contacts

Filippo Montemurro, MD

Role: CONTACT

fmontemurro@mauriziano.it

+39.011.9933 ext. 278

Manuela Muliello, Study Coordinator

Role: CONTACT

mmuliello@mauriziano.it

+39.011.9933 ext. 278

Other Identifiers

EudraCT No: 2008-001916-18

Identifier Type: -

Identifier Source: secondary_id

20080331 - HERLAP

Identifier Type: -

Identifier Source: org_study_id