Breast CancerNCT02305641
An Observational Study of Kadcyla Safety in Breast Cancer
An observational study of Breast Cancer, run by Hoffmann-La Roche at 38 sites in South Korea.
Trial summary
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- How many people
- 563 participants
- Where
- 38 sitesSouth Korea
- Study dates
- 21 May 2015to 10 Aug 2021
- 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: Korean patients administered Kadcyla infusion at physician's discretion
Who may be able to join
- Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea.
Who cannot join
- Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.
- A pediatric patient (age ≤18 years)
- Hypersensitivity for Kadcyla or any ingredient in this product
Trial locations and contacts
38 sites in 1 country.
38 sites in 1 country
South Korea38 sites
Inje University Busan Paik Hospital
Busan, 47392
Dong-A University Hospital
Busan, 49201
Kosin University Gospel Hospital
Busan, 49267
Pusan National University Hospital
Busan, 602-739
Kyungpook National University Chilgok Hospital
Daegu, 41404
Keimyung University Dongsan Medical Center
Daegu, 41931
Yeungnam University Medical Center; Surgical Department of Breast and Internal Secretion
Daegu
Chungnam National University Hospital
Daejeon, 35015
Uijeongbu St. Mary's Hospital
Gyeonggi-do, 11765
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, 14584
Bucheon St Mary's hospital
Gyeonggi-do, 14647
St. Vincent's Hospital
Gyeonggi-do, 16247
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Gachon University Gil Medical Center
Incheon, 21565
Inha University Hospital
Incheon, 22332
Catholic Kwandong University International St. Mary'S Hospital.
Incheon
Chonbuk National Uni Hospital
Jeollabuk-do, 561-712
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Presbyterian Medical Center
Jeonju, 54987
Wonkwang University School of Medicine & Hospital
Jeonlabuk-do, 54538
NHIC Ilsan Hospital
Kyonggi-do, 411-719
Severance Hospital, Yonsei University Health System
Seoul, 003-722
Korea Cancer Center Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812
Korea University Anam Hospital
Seoul, 02841
Seoul National University Hospital
Seoul, 03080
Kangbuk Samsung Hospital
Seoul, 03181
Konkuk University Medical Center
Seoul, 05030
Gangdong Kyung Hee University Hospital
Seoul, 05278
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
ChungAng University Hospital
Seoul, 06973
Yeouido St. Mary's Hospital
Seoul, 07345
Ewha Womans University Mokdong Hospital
Seoul, 07985
Samsung Medical Center
Seoul, 135-710
SMG-SNU Boramae Medical Center
Seoul, 156-707
Ajou University Hospital
Suwon, 443-721
Ulsan University Hosiptal
Ulsan, 44033
About this study
Official title: Post-Marketing Surveillance of Kadcyla in Breast Cancer
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 years.
- Conditions
- Breast Cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Cohort | Method of continuous surveillance per standard of care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs
Measured: Up to 8 years
Secondary outcomes (1)
Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
Measured: Up to 8 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2014 (estimated)
- Study start21 May 2015
- Primary completion10 Aug 2021
- Study completion10 Aug 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe 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
- Cohort
- Time perspective
- Prospective
- Enrolment
- 563 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02305641
- Sponsor's protocol ID
- ML29629
- Status last verified
- Jan 2023
- First submitted
- 28 Nov 2014
- Last updated
- 11 Jan 2023
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Kadcyla in Breast Cancer
- ClinicalTrials.gov ID
- NCT02305641
- Acronym / sponsor ID
- ML29629
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 563 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 21 May 2015 (actual)
- Primary completion
- 10 Aug 2021 (actual)
- Study completion
- 10 Aug 2021 (actual)
- First posted
- 2 Dec 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.
This is a phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) in approximately 500 patients who are to receive Kadcyla (trastuzumab emtansine). Patients administered Kadcyla infusion at physician's discretion will be registered for this surveillance in Korea. Patients will be asked to provide informed consent; data will be collected by electronic Case Report Forms for approximately 8 years.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Cohort | – | –Method of continuous surveillance per standard of care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Korean patients administered Kadcyla infusion at physician's discretion
Key inclusion criteria (1 listed)
- Patients who are administered with Kadcyla at physician's discretion will be registered for this study. The use of Kadcyla in the patients must fall into the approved indication in Korea.
Key exclusion criteria (3 listed)
- Patients not receiving treatment for breast cancer with Kadcyla according to standard of care and in line with the current summary of product characteristics (SPC)/local labeling.
- A pediatric patient (age ≤18 years)
- Hypersensitivity for Kadcyla or any ingredient in this product
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
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs
Time frame: Up to 8 years
1 secondary outcome
Efficacy (composite outcome measure): Tumor response to Kadcyla treatment including complete response (CR), partial response (PR), stable disease (SD), or progressive disease (PD)
Time frame: Up to 8 years
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 11 Jan 2023.
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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.
Clinical Trials study director
Hoffmann-La Roche
38 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 Cancer, run by Hoffmann-La Roche at 38 sites in South Korea.
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 1 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 11 Jan 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 38 sites in 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?
Safety (composite outcome measure): Incidence of serious adverse events (SAEs), adverse drug reactions (ADRs); unexpected adverse events and ADRs; expected ADRs; non-serious ADRs (time frame: Up to 8 years). 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 11 Jan 2023.