CancerNCT01462604
Pilot Study of Patient's Adherence to TYKERB™/TYVERB™ + Capecitabine in Metastatic Breast Cancer
An observational study of Cancer, run by GlaxoSmithKline at 7 sites in 4 countries.
Trial summary
This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients 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?
- non-drug intervention educational programme
- How many people
- 27 participants
- Where
- 7 sitesin 4 countries
- Study dates
- 23 Nov 2011to 24 Jan 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: Women older than 18 years old with metastatic or advanced breast cancer
Who may be able to join
- Signed written informed consent;
- Female outpatient aged 18 years or older;
- Subjects must be about to begin their initial treatment with lapatinib + capecitabine for HER2+ metastatic or advanced breast cancer according to physician's clinical judgement as per local prescribing information
- Subjects must be literate, be able to read, understand and write local language.
Who cannot join
- Women who is participating in any other interventional clinical trials concurrently;
- Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;
- Primary lesions that are not of breast origin.
Trial locations and contacts
7 sites in 4 countries.
7 sites in 4 countries
Hong Kong2 sites
GSK Investigational Site
Pokfulam
GSK Investigational Site
Shatin
Pakistan2 sites
GSK Investigational Site
Karachi
GSK Investigational Site
Lahore, 54600
Singapore2 sites
GSK Investigational Site
Singapore, 258500
GSK Investigational Site
Singapore, 308433
About this study
Official title: PROACTYVE Pilot:Pilot Study of Patient's Adherence to TYKERB™/TYVERB™+Capecitabine in Metastatic Breast Cancer-Observation of Patient Adherence and Evaluation of Predictive Factors for Patient Adherence After Providing Educational Programme
This is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients
Read the detailed description
Approximately 60 subjects with HER2+ metastatic or advanced breast cancer who meet the inclusion/exclusion criteria will be enrolled into the study. All subjects will receive education intervention for 6 weeks including education on Day 0, follow-up phone calls on Day 1 and Day 7, reminder phone calls before Week 3 and 6 visit and telephone hot line number.
- Conditions
- Cancer
- Being tested
- non-drug intervention educational programme
- Medical subject headings
- Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non-drug intervention educational programmeOther
educational programme
| Study group | Role | What they receive |
|---|---|---|
| HER2 overexpressing metastatic or advanced breast cancer pts | Not described Receives: Other: non-drug intervention educational programme |
What is being measured
The primary outcome is the main question the study is designed to answer.
Subject recruitment and retention in the study
Assess the feasibility of recruitment and retention of subjects into the education program
Measured: upto week 6
Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6
Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes
Measured: week 3 & 6
Patient knowledge, attitude and beliefs about the regimen
Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes
Measured: Day 0, Week 3 and Week 6
Acceptability of study procedures and educational materials at Week 6
Evaluate the implementation and acceptability of the education materials and study procedures
Measured: week 6
Secondary outcomes (1)
Serious adverse events and adverse events up to 6 weeks
Safety during education intervention
Measured: upto week 6
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Oct 2011 (estimated)
- Study start23 Nov 2011
- Primary completion1 Jan 2013
- Study completion24 Jan 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.
- More trials run by GlaxoSmithKlineThe sponsor's other registered studies.
- 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
- Case only
- Time perspective
- Prospective
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- GlaxoSmithKline
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- GSK Clinical Trials, Study director, GlaxoSmithKline
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01462604
- Sponsor's protocol ID
- 115553
- Status last verified
- Jun 2018
- First submitted
- 21 Sep 2011
- Last updated
- 19 Jun 2018
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Jun 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PROACTYVE Pilot:Pilot Study of Patient's Adherence to TYKERB™/TYVERB™+Capecitabine in Metastatic Breast Cancer-Observation of Patient Adherence and Evaluation of Predictive Factors for Patient Adherence After Providing Educational Programme
- ClinicalTrials.gov ID
- NCT01462604
- Acronym / sponsor ID
- 115553
- Conditions
- Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- GlaxoSmithKlineIndustry (pharma, biotech, devices)
- Study start
- 23 Nov 2011
- Primary completion
- 1 Jan 2013 (actual)
- Study completion
- 24 Jan 2013 (actual)
- First posted
- 31 Oct 2011 (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 is a 6-week, single arm, pilot study to test the study procedure, educational materials, and measurement instruments for the educational intervention in HER2 overexpressing metastatic or advanced breast cancer patients
Detailed description
Approximately 60 subjects with HER2+ metastatic or advanced breast cancer who meet the inclusion/exclusion criteria will be enrolled into the study. All subjects will receive education intervention for 6 weeks including education on Day 0, follow-up phone calls on Day 1 and Day 7, reminder phone calls before Week 3 and 6 visit and telephone hot line number.
Study design
- Observational model
- Case only
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| HER2 overexpressing metastatic or advanced breast cancer pts | – | Other: non-drug intervention educational programme |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Women older than 18 years old with metastatic or advanced breast cancer
Key inclusion criteria (4 listed)
- Signed written informed consent;
- Female outpatient aged 18 years or older;
- Subjects must be about to begin their initial treatment with lapatinib + capecitabine for HER2+ metastatic or advanced breast cancer according to physician's clinical judgement as per local prescribing information
- Subjects must be literate, be able to read, understand and write local language.
Key exclusion criteria (3 listed)
- Women who is participating in any other interventional clinical trials concurrently;
- Women who is already taking or had taken lapatinib + capecitabine regimen prior to the enrollment;
- Primary lesions that are not of breast origin.
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 |
|---|---|---|
| non-drug intervention educational programmeeducational programme | Other | HER2 overexpressing metastatic or advanced breast cancer pts |
Primary outcome
Subject recruitment and retention in the study
Time frame: upto week 6
Assess the feasibility of recruitment and retention of subjects into the education program
Adherence at Week 3 and Week 6 (MARS-6) and persistence at Week 6
Time frame: week 3 & 6
Pilot test tools to measure subject adherence to the lapatinib + capecitabine regimen, assess persistence and describe these outcomes
Patient knowledge, attitude and beliefs about the regimen
Time frame: Day 0, Week 3 and Week 6
Pilot test tools to measure subject knowledge, attitudes, and beliefs about the lapatinib + capecitabine regimen and describe these outcomes
Acceptability of study procedures and educational materials at Week 6
Time frame: week 6
Evaluate the implementation and acceptability of the education materials and study procedures
1 secondary outcome
Serious adverse events and adverse events up to 6 weeks
Time frame: upto week 6
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 19 Jun 2018.
Related trials for Cancer
Not yet recruitingPhase 1
Hepatic Artery Infusion of Carfilzomib in Participants With Liver Metastatic Disease Previously Treated With Hepatic Artery Infusion Pump Therapy
Colorectal Neoplasms, Neoplasms
RecruitingPhase 2
Tafasitamab With Acalabrutinib and Venetoclax for the Treatment of Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Chronic Lymphocytic Leukemia, Chronic Lymphocytic Leukemia/Small Lymphocytic Lymphoma
Active, not recruitingPhase 1/2
Selumetinib in Treating Young Patients With Recurrent or Refractory Low Grade Glioma
Low Grade Glioma, Recurrent Childhood Pilocytic Astrocytoma
Enrolling by invitationPhase 2
A Single-Arm Study of Nimotuzumab Combined With NALIRIFOX as First-Line Treatment for Pancreatic Cancer
Pancreatic Cancer Metastatic
Recruiting
Methylation Profiling in Self-Samples for Identification of (Epi)Genetic Biomarkers for Gynecological Cancers
Gynaecological Cancers, Ovarian Cancer
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.
GSK Clinical Trials study director
GlaxoSmithKline
7 sites in 4 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Cancer, run by GlaxoSmithKline at 7 sites in 4 countries.
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 4 inclusion and 3 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 19 Jun 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in Hong Kong, Pakistan, Singapore, South Korea. 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?
Subject recruitment and retention in the study (time frame: upto week 6). The study lists 4 primary outcomes in all. 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 19 Jun 2018.