CancerTYCONCT01160094
Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
An observational study of Cancer, run by Novartis at 10 sites in 2 countries.
Trial summary
It will be conducted as an international multicenter prospective observational cohort study in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine… Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Cancer
- What is being tested?
- Treatment
- How many people
- 288 participants
- Where
- 10 sitesin 2 countries
- Study dates
- Feb 2010to Jul 2013
- 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
- Women only
- No healthy volunteers
- Adult, Older adult
Study population: All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting. Patients from private and public settings.
- Women with ErbB2+ MBC (ErbB2 expression confirmed by immunohistochemistry or FISH/CISH, either in the primary tumor or in the metastasis, according to the institution's common practice);
- Older than 18 years old;
- Have received prior treatment with trastuzumab-containing regimen for ErbB2+ breast cancer;
- Progressing after trastuzumab-containing regimen either used for the treatment of metastatic disease or progressing after adjuvant /neoadjuvant trastuzumab treatment;
- Eligible to start standard treatment with Lapatinib-capecitabine at conventional doses, OR receiving standard treatment with
- Lapatinib-capecitabine at conventional doses, for no longer than 10 weeks from the start of the treatment to the date of inclusion in the study;
- Signed consent to participate and release information for this study.
Trial locations and contacts
10 sites in 2 countries.
10 sites in 2 countries
Colombia5 sites
Novartis Investigative Site
Bogotá
Novartis Investigative Site
Bucaramanga
Novartis Investigative Site
Medellín
Novartis Investigative Site
Pasto
Novartis Investigative Site
Pereira
Saudi Arabia5 sites
Novartis Investigative Site
Dammam, Dammam 31444
Novartis Investigative Site
Jeddah, 21499
Novartis Investigative Site
Jeddah, jEDDAH 21423
Novartis Investigative Site
Jeddah
Novartis Investigative Site
Riyadh
About this study
Official title: Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
It will be conducted as an international multicenter prospective observational cohort study in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).
Read the detailed description
Lapatinib in combination with capecitabine is a standard of care treatment for ErbB2+ metastatic breast cancer (MBC) patients who have progressed after anthracyclines, taxanes and trastuzumab treatment. Results from the lapatinib pivotal trial showed that the addition of lapatinib to capecitabine increased median time to progression (TTP) even among heavily pre-treated patients (median of 4 prior lines of therapy). A recent ad hoc subset analysis of this trial suggested that earlier administration of lapatinib-capecitabine in MBC patients who progress after trastuzumab may produce better clinical outcomes. The TYCO study was designed to evaluate if early switch to lapatinib-capecitabine in patients with ErbB2+ MBC who have progressed on trastuzumab-containing regimen improves TTP in comparison with a later start (after several lines of therapy). Secondary objectives include Overall Response Rate (ORR), 1 year Overall Survival (OS), and description of reported serious adverse events. This is an international, multicenter, prospective, observational (non-interventional) study in 269 ErbB2+MBC patients whose disease has progressed after treatment with trastuzumab. Two cohorts will be compared; Group 1: patients receiving lapatinib-capecitabine immediately after first trastuzumab progression, and Group 2: patients receiving lapatinib-capecitabine after two or more lines of treatment after first trastuzumab progression. Eligibility criteria include females aged 18 or more with confirmed ErbB2+ MBC who have progressed after a previous trastuzumab-containing regimen, eligible to start standard therapy with lapatinib-capecitabine at approved conventional doses, as per local label approval. The study duration is of 12 months with data collection at baseline and approximately every 3 months thereafter. Patient evaluations will be conducted per standard patient care in each center and TTP will be determined by the treating physician (clinically or radiologically). Enrollment started in February 2010 and completion of accrual is estimated for December 2011.
- Conditions
- Cancer
- Being tested
- Treatment
- Keywords
- Trastuzumab, Metastatic Breast Cancer, Breast Cancer, Observational Study, Lapatinib
- Medical subject headings
- Neoplasms, Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TreatmentDrug
patients treated with Lapatinib-Capecitabine after Trastuzumab Progression
| Study group | Role | What they receive |
|---|---|---|
| Patients | ErbB2+ metastatic breast cancer patients Receives: Drug: Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Time to disease progression
the time from the date of start of Lapatinib capecitabine treatment until date of documented disease progression by the treating physician
Measured: One year
Secondary outcomes (2)
Overall Response Rate
the percentage of patients showing complete response (CR) and partial response (PR) to the given treatment.
Measured: One year
Overall survival
the time from the start of lapatinib capecitabine treatment until death due to any cause
Measured: measured at the end of follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2010 (estimated)
- Study startFeb 2010
- Primary completionJul 2013
- Study completionJul 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 288 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novartis
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Novartis Pharmaceuticals, Study director, Novartis Pharmaceuticals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01160094
- Sponsor's protocol ID
- 113780
- Acronym
- TYCO
- Status last verified
- Mar 2016
- First submitted
- 8 Jul 2010
- Last updated
- 28 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Clinical Outcomes on ErbB2+ MBC Patients Treated With Lapatinib-Capecitabine After Trastuzumab Progression: Role of Early Versus Late Switch to Lapatinib-Capecitabine (TYCO)
- ClinicalTrials.gov ID
- NCT01160094
- Acronym / sponsor ID
- TYCO / 113780
- Conditions
- Cancer
- Keywords
- Trastuzumab, Metastatic Breast Cancer, Breast Cancer, Observational Study, Lapatinib
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 288 participants (actual)
- Lead sponsor
- NovartisIndustry (pharma, biotech, devices)
- Study start
- Feb 2010
- Primary completion
- Jul 2013 (actual)
- Study completion
- Jul 2013 (actual)
- First posted
- 12 Jul 2010 (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.
It will be conducted as an international multicenter prospective observational cohort study in a population of ErbB2 positive metastatic breast cancer patients, whose disease has progressed after trastuzumab-containing regimen, comparing outcomes in two groups: Group 1: patients receiving Lapatinib-capecitabine immediately after 1st Trastuzumab progression (second line treatment), and Group 2: patients receiving Lapatinib-capecitabine after 2 or more lines of treatment after 1st trastuzumab progression (third line or greater).
Detailed description
Lapatinib in combination with capecitabine is a standard of care treatment for ErbB2+ metastatic breast cancer (MBC) patients who have progressed after anthracyclines, taxanes and trastuzumab treatment. Results from the lapatinib pivotal trial showed that the addition of lapatinib to capecitabine increased median time to progression (TTP) even among heavily pre-treated patients (median of 4 prior lines of therapy). A recent ad hoc subset analysis of this trial suggested that earlier administration of lapatinib-capecitabine in MBC patients who progress after trastuzumab may produce better clinical outcomes. The TYCO study was designed to evaluate if early switch to lapatinib-capecitabine in patients with ErbB2+ MBC who have progressed on trastuzumab-containing regimen improves TTP in comparison with a later start (after several lines of therapy). Secondary objectives include Overall Response Rate (ORR), 1 year Overall Survival (OS), and description of reported serious adverse events. This is an international, multicenter, prospective, observational (non-interventional) study in 269 ErbB2+MBC patients whose disease has progressed after treatment with trastuzumab. Two cohorts will be compared; Group 1: patients receiving lapatinib-capecitabine immediately after first trastuzumab progression, and Group 2: patients receiving lapatinib-capecitabine after two or more lines of treatment after first trastuzumab progression. Eligibility criteria include females aged 18 or more with confirmed ErbB2+ MBC who have progressed after a previous trastuzumab-containing regimen, eligible to start standard therapy with lapatinib-capecitabine at approved conventional doses, as per local label approval. The study duration is of 12 months with data collection at baseline and approximately every 3 months thereafter. Patient evaluations will be conducted per standard patient care in each center and TTP will be determined by the treating physician (clinically or radiologically). Enrollment started in February 2010 and completion of accrual is estimated for December 2011.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients | – | Drug: TreatmentErbB2+ metastatic breast cancer patients |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- All cases of ErbB2 positive metastatic breast cancer, receiving approved standard treatment with lapatinib-capecitabine, after trastuzumab-containing regimen progression in community setting. Patients from private and public settings.
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 |
|---|---|---|
| Treatmentpatients treated with Lapatinib-Capecitabine after Trastuzumab Progression | Drug | Patients |
Primary outcome
Time to disease progression
Time frame: One year
the time from the date of start of Lapatinib capecitabine treatment until date of documented disease progression by the treating physician
2 secondary outcomes
Overall Response Rate
Time frame: One year
Overall survival
Time frame: measured at the end of follow-up
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 28 Mar 2016.
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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.
Novartis Pharmaceuticals study director
Novartis Pharmaceuticals
10 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by Novartis at 10 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
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 28 Mar 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in Colombia, Saudi Arabia. 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?
Time to disease progression (time frame: One year). 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 28 Mar 2016.