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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified June 2009 by Azienda Ospedaliera Ordine Mauriziano di Torino.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Azienda Ospedaliera Ordine Mauriziano di Torino
ClinicalTrials.gov Identifier:
NCT00842998
First received: February 11, 2009
Last updated: June 25, 2009
Last verified: June 2009
  Purpose

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


Condition Intervention Phase
Metastatic Breast Cancer
Drug: Trastuzumab or Lapatinib
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase II, Randomized Trial With Single Agent Trastuzumab or Lapatinib in Patients With Metastatic HER2-Overexpressing Breast Cancer

Resource links provided by NLM:


Further study details as provided by Azienda Ospedaliera Ordine Mauriziano di Torino:

Primary Outcome Measures:
  • Evidence of clinically definite response confirmed by CT or MRI [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Time to Progression (TTP) and duration of response in patients treated with Trastuzumab [ Time Frame: 8 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 120
Study Start Date: February 2009
Estimated Study Completion Date: December 2011
Estimated Primary Completion Date: December 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1 - Trastuzumab
Day1 Week1: 8 mg/kg iv in 90 min. Following 1st week: 2 mg/kg once/weekly for 8 weeks
Drug: 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
Experimental: 2 - Lapatinib
1500 mg/die orally
Drug: 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

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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).
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00842998

Contacts
Contact: Filippo Montemurro, MD +39.011.9933 ext 278 fmontemurro@mauriziano.it
Contact: Manuela Muliello, Study Coordinator +39.011.9933 ext 278 mmuliello@mauriziano.it

Locations
Italy
U.O. Oncologia Medica - Ospedale San Luigi Active, not recruiting
Orbassano, Torino, Italy, 10043
Institute for Cancer Research and Treatment (I.R.C.C.) Recruiting
Candiolo , Torino, Italy, 10060
Principal Investigator: Filippo Montemurro, MD         
U.O. Oncologia Medica Active, not recruiting
Cuneo, Italy, 12100
U.O. Oncologia Medica - COES Molinette Active, not recruiting
Torino, Italy, 10126
Sponsors and Collaborators
Azienda Ospedaliera Ordine Mauriziano di Torino
Investigators
Study Chair: Massimo Aglietta, Full Professor, MD University of Turin Medical School at AO Ordine Mauriziano di Torino
Principal Investigator: Filippo Montemurro, MD AO Ordine Mauriziano di Torino
  More Information

No publications provided

Responsible Party: Prof. Massimo Aglietta / Dr Filippo Montemurro, I.R.C.C. - A.O. Ordine Mauriziano di Torino
ClinicalTrials.gov Identifier: NCT00842998     History of Changes
Other Study ID Numbers: 20080331 - HERLAP, EudraCT No: 2008-001916-18
Study First Received: February 11, 2009
Last Updated: June 25, 2009
Health Authority: Italy: Ethics Committee
Italy: National Monitoring Centre for Clinical Trials - Ministry of Health
Italy: The Italian Medicines Agency

Keywords provided by Azienda Ospedaliera Ordine Mauriziano di Torino:
breast cancer
HER2
Trastuzumab
Lapatinib
HER2 gene-amplification

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Lapatinib
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions
Protein Kinase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action

ClinicalTrials.gov processed this record on September 14, 2014