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

NCT00842998 | Unknown Phase 2

• 2 other identifiers: 20080331 - HERLAPEudraCT No: 2008-001916-18
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 4

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

Keywords

breast cancer; HER2; Trastuzumab; Lapatinib; HER2 gene-amplification

Outcome Measures

Primary Outcomes (1)

• Evidence of clinically definite response confirmed by CT or MRI

  8 weeks

Secondary Outcomes (1)

• Time to Progression (TTP) and duration of response in patients treated with Trastuzumab

  8 weeks

Study Arms (2)

1 - Trastuzumab

EXPERIMENTAL

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

Drug: Trastuzumab or Lapatinib

2 - Lapatinib

EXPERIMENTAL

1500 mg/die orally

Drug: Trastuzumab or Lapatinib

Interventions

Trastuzumab or Lapatinib DRUG

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

1 - Trastuzumab; 2 - Lapatinib

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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).

Sponsors & Collaborators

• Azienda Ospedaliera Ordine Mauriziano di Torino: lead

Study Sites (4)

U.O. Oncologia Medica - Ospedale San Luigi

Orbassano, Torino, 10043, Italy

ACTIVE NOT RECRUITING

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

Candiolo , Torino, 10060, Italy

RECRUITING

U.O. Oncologia Medica

Cuneo, 12100, Italy

ACTIVE NOT RECRUITING

U.O. Oncologia Medica - COES Molinette

Torino, 10126, Italy

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Trastuzumab; Lapatinib

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Quinazolines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds

Study Officials

• Massimo Aglietta, Full Professor, MD

  University of Turin Medical School at AO Ordine Mauriziano di Torino

  STUDY CHAIR

• Filippo Montemurro, MD

  AO Ordine Mauriziano di Torino

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Filippo Montemurro, MD

CONTACT

+39.011.9933; fmontemurro@mauriziano.it

Manuela Muliello, Study Coordinator

CONTACT

+39.011.9933; mmuliello@mauriziano.it

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: February 11, 2009
• First Posted: February 12, 2009
• Study Start: February 1, 2009
• Primary Completion: December 1, 2011
• Study Completion: December 1, 2011
• Last Updated: June 26, 2009

Record last verified: 2009-06

Locations

IT (4)