Metastatic Breast CancerPhase 2HERLAPNCT00842998
Efficacy Study of Single Agent Trastuzumab or Lapatinib to Treat HER2-Overexpressing Breast Cancer
A Phase 2 study testing Trastuzumab or Lapatinib in people with Metastatic Breast Cancer, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 4 sites in Italy.
Trial 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 Read more about this study
- Who is it for?
- Ages 18 to 75 years, women only
- Conditions the study is for
- Metastatic Breast Cancer
- What is being tested?
- Trastuzumab or Lapatinib
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 4 sitesItaly
- Study dates
- Feb 2009to Dec 2011
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
Who cannot join
- 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.
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- 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).
Trial locations and contacts
4 sites in 1 country.
Italy4 sites, 1 recruiting
- Recruiting
Institute for Cancer Research and Treatment (I.R.C.C.)
Candiolo , Torino, 10060
Filippo Montemurro, MD
- Active, not recruiting
U.O. Oncologia Medica
Cuneo, 12100
- Active, not recruiting
U.O. Oncologia Medica - Ospedale San Luigi
Orbassano, Torino, 10043
- Active, not recruiting
U.O. Oncologia Medica - COES Molinette
Torino, 10126
About this study
Official title: A Phase II, Randomized Trial With Single Agent Trastuzumab or Lapatinib in Patients With Metastatic HER2-Overexpressing Breast Cancer
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
- Being tested
- Trastuzumab or Lapatinib
- Keywords
- breast cancer, HER2, Trastuzumab, Lapatinib, HER2 gene-amplification
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Trastuzumab or LapatinibDrug
Trastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally
| Study group | Role | What they receive |
|---|---|---|
| 1 - Trastuzumab | Experimental | Day1 Week1: 8 mg/kg iv in 90 min. Following 1st week: 2 mg/kg once/weekly for 8 weeks Receives: Drug: Trastuzumab or Lapatinib |
| 2 - Lapatinib | Experimental | 1500 mg/die orally Receives: Drug: Trastuzumab or Lapatinib |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evidence of clinically definite response confirmed by CT or MRI
Measured: 8 weeks
Secondary outcomes (1)
Time to Progression (TTP) and duration of response in patients treated with Trastuzumab
Measured: 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Feb 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2011 (estimated)
- Study completionDec 2011 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metastatic Breast CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di Torino
- Sponsor type
- University, hospital or other
- Investigators
- Massimo Aglietta, Full Professor, MD, Study chair, University of Turin Medical School at AO Ordine Mauriziano di TorinoFilippo Montemurro, MD, Principal investigator, AO Ordine Mauriziano di Torino
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00842998
- Sponsor's protocol ID
- 20080331 - HERLAP
- Other IDs
- EudraCT No: 2008-001916-18
- Acronym
- HERLAP
- Status last verified
- Jun 2009
- First submitted
- 11 Feb 2009
- Last updated
- 26 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II, Randomized Trial With Single Agent Trastuzumab or Lapatinib in Patients With Metastatic HER2-Overexpressing Breast Cancer
- ClinicalTrials.gov ID
- NCT00842998
- Acronym / sponsor ID
- HERLAP / 20080331 - HERLAP
- Conditions
- Metastatic Breast Cancer
- Keywords
- breast cancer, HER2, Trastuzumab, Lapatinib, HER2 gene-amplification
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Azienda Ospedaliera Ordine Mauriziano di TorinoUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2011 (estimated)
- Study completion
- Dec 2011 (estimated)
- First posted
- 12 Feb 2009 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 - Trastuzumab | Experimental | Drug: Trastuzumab or LapatinibDay1 Week1: 8 mg/kg iv in 90 min. Following 1st week: 2 mg/kg once/weekly for 8 weeks |
| 2 - Lapatinib | Experimental | Drug: Trastuzumab or Lapatinib1500 mg/die orally |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (20 listed)
- 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.
Key exclusion criteria (15 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab or LapatinibTrastuzumab: loading dose 8 mg/kg iv in 90 min.followed by weekly doses of 2 mg/kg Lapatinib: 1500 mg/die orally | Drug | 1 - Trastuzumab, 2 - Lapatinib |
Primary outcome
Evidence of clinically definite response confirmed by CT or MRI
Time frame: 8 weeks
1 secondary outcome
Time to Progression (TTP) and duration of response in patients treated with Trastuzumab
Time frame: 8 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Jun 2009.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Massimo Aglietta, Full Professor, MD study chair
University of Turin Medical School at AO Ordine Mauriziano di Torino
Filippo Montemurro, MD principal investigator
AO Ordine Mauriziano di Torino
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Trastuzumab or Lapatinib in people with Metastatic Breast Cancer, run by Azienda Ospedaliera Ordine Mauriziano di Torino at 4 sites in Italy.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 20 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 26 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in Italy. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Filippo Montemurro, MD (+39.011.9933 ext. 278, fmontemurro@mauriziano.it), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evidence of clinically definite response confirmed by CT or MRI (time frame: 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Jun 2009.