Breast NeoplasmTRASTYVERENCT02056080
Clinical Benefit of the Treatment With Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib
An observational study of Breast Neoplasm, run by MedSIR at 11 sites in Spain.
Trial summary
A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011 Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Neoplasm
- How many people
- 111 participants
- Where
- 11 sitesSpain
- Study dates
- Jan 2013to Jan 2014
- Phase
- Observational
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with HER2 positive metastatic breast cancer who progressed to antiHER2 therapy with trastuzumab and / or lapatinib for the metastasic disease and that between January 2005 and December 2011, began treatment with the combination of trastuzumab and lapatinib (TL).
Who may be able to join
- Confirmed diagnosis of metastatic breast cancer HER2-positive phenotype (confirmed by IHC 3 + or FISH positive)
- Older than 18 years
- Progressed to at least one prior treatment line for MBC with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
- Having the patient's complete medical history that contains all lines antiHER2 therapy treatment
- Being a patient who initiated the combination of trastuzumab and lapatinib between January 2005 and December 2011
- Inform the patient and get the signature of the informed consent
Who cannot join
- Not having phenotypic classification of the tumor by IHC or FISH test for HER2
- Being a patient with HER2-negative phenotype(FISH negative or IHC in range [0-2 +] without FISH)
- Being a patient who received the trastuzumab and/or lapatinib treatment (TL) in combination with chemotherapy
- Being a patient who, since January 2012, began TL therapy for metastatic disease.
Trial locations and contacts
11 sites in 1 country.
11 sites in 1 country
Spain11 sites
Study site
Barcelona
Study site
Córdoba
Study site
Girona
Study site
Jaén
Study site
Madrid
Study site
Pamplona
Study site
Salamanca
Study site
Santiago de Compostela
Study site
Seville
Study site
Valencia
Study site
Zaragoza
About this study
Official title: Observational, Retrospective and Multicenter Study to Evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib
A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011
- Conditions
- Breast Neoplasm
- Keywords
- Breast Neoplasm, Receptor,HER2, Antineoplastic agent, Antibodies, monoclonal, Trastuzumab, Lapatinib, Protein kinase inhibitors, quinazolines
- Medical subject headings
- Breast Neoplasms
What is being measured
The primary outcome is the main question the study is designed to answer.
Clinical response rate assessed by RECIST criteria
clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL.
This variable will be assessed by RECIST v 1.1
Measured: Up to 24 weeks from the first clinical response rate assessment
Secondary outcomes (4)
To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib
The progression will be evaluated by RECIST v 1.1.
Measured: Up to one year from the last dose of TL
To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines.
clinical benefit: defined as reaching a (complete or partial) objective response or stabilization of tumor for more than 24 weeks
Measured: Up to 24 weeks from the last dose of TL
To compare the time to progression of different subpopulations according to the biological characteristics of the tumor.
The progression will be evaluated by RECIST v 1.1.
Measured: Up to one year from the last dose of TL
To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit
Adverse reactions observed during treatment of the combination TL, measured with scale CTCAE v.4
Measured: Up to one year from the last dose of TL
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Feb 2014 (estimated)
- Study startJan 2013
- Primary completionJan 2014
- Study completionJan 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmStudies 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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 111 participants (actual)
Sponsor and investigators
- Lead sponsor
- MedSIR
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Joaquin Gávila, MD, Principal investigator, Valencia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02056080
- Sponsor's protocol ID
- MED-DBL-2012-01
- Acronym
- TRASTYVERE
- Status last verified
- Sep 2019
- First submitted
- 10 Jan 2014
- Last updated
- 9 Sep 2019
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Observational, Retrospective and Multicenter Study to Evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib
- ClinicalTrials.gov ID
- NCT02056080
- Acronym / sponsor ID
- TRASTYVERE / MED-DBL-2012-01
- Conditions
- Breast Neoplasm
- Keywords
- Breast Neoplasm, Receptor,HER2, Antineoplastic agent, Antibodies, monoclonal, Trastuzumab, Lapatinib, Protein kinase inhibitors, quinazolines
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 111 participants (actual)
- Lead sponsor
- MedSIRUniversity, hospital or other
- Study start
- Jan 2013 (actual)
- Primary completion
- Jan 2014 (actual)
- Study completion
- Jan 2014 (actual)
- First posted
- 5 Feb 2014 (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.
A retrospective, observational, not EPA, multicenter study to evaluate the Clinical Benefit of Trastuzumab in Combination With Lapatinib in Metastatic Breast Cancer HER2 Positive Patients Who Has Been Previously Treated With Trastuzumab and/or Lapatinib between January 2005 and December 2011
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with HER2 positive metastatic breast cancer who progressed to antiHER2 therapy with trastuzumab and / or lapatinib for the metastasic disease and that between January 2005 and December 2011, began treatment with the combination of trastuzumab and lapatinib (TL).
Key inclusion criteria (6 listed)
- Confirmed diagnosis of metastatic breast cancer HER2-positive phenotype (confirmed by IHC 3 + or FISH positive)
- Older than 18 years
- Progressed to at least one prior treatment line for MBC with trastuzumab and / or lapatinib, either as monotherapy or in combination with chemotherapy or hormonal therapy schemes
- Having the patient's complete medical history that contains all lines antiHER2 therapy treatment
- Being a patient who initiated the combination of trastuzumab and lapatinib between January 2005 and December 2011
Key exclusion criteria (4 listed)
- Not having phenotypic classification of the tumor by IHC or FISH test for HER2
- Being a patient with HER2-negative phenotype(FISH negative or IHC in range [0-2 +] without FISH)
- Being a patient who received the trastuzumab and/or lapatinib treatment (TL) in combination with chemotherapy
- Being a patient who, since January 2012, began TL therapy for metastatic disease.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Clinical response rate assessed by RECIST criteria
Time frame: Up to 24 weeks from the first clinical response rate assessment
clinical benefit rate (CBR): defined as the percentage of patients who achieved an objective response (CR or PR) or tumor stabilization for at least 24 weeks or more during the period of treatment with the combination TL. This variable will be assessed by RECIST v 1.1
4 secondary outcomes
To evaluate the progression-free survival in patients treated TL combination , previously treated with trastuzumab and / or lapatinib
Time frame: Up to one year from the last dose of TL
To compare the clinical benefit and time to intra-patient progression between the combination TL and previous treatment lines.
Time frame: Up to 24 weeks from the last dose of TL
To compare the time to progression of different subpopulations according to the biological characteristics of the tumor.
Time frame: Up to one year from the last dose of TL
To identify the toxicity profile of the combination TL as a factor related to the intra-patient clinical benefit
Time frame: Up to one year from the last dose of TL
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2019.
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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.
Joaquin Gávila, MD principal investigator
Valencia
11 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasm, run by MedSIR at 11 sites in Spain.
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 6 inclusion and 4 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: finished, as of the sponsor's last update on 9 Sep 2019. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 11 sites in Spain. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Clinical response rate assessed by RECIST criteria (time frame: Up to 24 weeks from the first clinical response rate assessment). 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 9 Sep 2019.