Breast CancerNCT02305628
An Observational Study of Herceptin SC Safety in Breast Cancer
An observational study of Breast Cancer, run by Hoffmann-La Roche at 23 sites in South Korea.
Trial summary
This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care 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
- 600 participants
- Where
- 23 sitesSouth Korea
- Study dates
- 26 Jun 2015to 31 Jan 2020
- 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 receiving treatment for breast cancer with Herceptin SC under observation according to standard of care and in line with the current local labeling in Korea.
Who may be able to join
- All patients administered Herceptin SC for the locally approved indications
Who cannot join
- N/A
Trial locations and contacts
23 sites in 1 country.
23 sites in 1 country
South Korea23 sites
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Keimyung University Dongsan Medical Center
Daegu, 41931
Myongji Hospital
Gyeonggi-do, 10475
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068
Ajou University Medical Center
Gyeonggi-do, 16499
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Gyeongsang National University Hospital
Gyeongsangnam-do, 52727
Gachon University Gil Medical Center
Incheon, 21565
Inha University Hospital
Incheon, 22332
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Wonkwang University School of Medicine & Hospital
Jeonlabuk-do, 54538
Samsung Medical Center
Seoul, (0)6351
Inje University, Sanggye-Paik Hospital
Seoul, 01757
Korea Cancer Hospital of Korea Institute of Radiological and Medical Sciences
Seoul, 01812
Severance Hospital, Yonsei University Health System
Seoul, 03722
Cheil General Hospital & Women's Healthcare Center
Seoul, 04619
Gangnam Severance Hospital
Seoul, 06273
ChungAng University Hospital
Seoul, 06973
Borame Medical Center
Seoul, 07061
Ewha Womans University Mokdong Hospital
Seoul, 07985
Miz Medi Hospital
Seoul
Ulsan University Hosiptal
Ulsan, 44033
About this study
Official title: Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer
This is a phase IV, prospective, multicenter, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.
- 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 adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs
Measured: Up to 6 years
Secondary outcomes (2)
Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)
Measured: Up to 6 years
Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Up to 6 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 start26 Jun 2015
- Primary completion31 Jan 2020
- Study completion31 Jan 2020
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
- 600 participants (estimated)
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
- NCT02305628
- Sponsor's protocol ID
- ML29625
- Status last verified
- Nov 2020
- First submitted
- 28 Nov 2014
- Last updated
- 16 Nov 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Nov 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Herceptin Subcutaneous in Breast Cancer
- ClinicalTrials.gov ID
- NCT02305628
- Acronym / sponsor ID
- ML29625
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 26 Jun 2015 (actual)
- Primary completion
- 31 Jan 2020 (actual)
- Study completion
- 31 Jan 2020 (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, observational study (regulatory post-marketing surveillance) in approximately 600 patients who are to receive Herceptin SC (trastuzumab, subcutaneous administration) per approved local labeling. Patients will be under observation according to standard of care in Korea.
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
- Patients receiving treatment for breast cancer with Herceptin SC under observation according to standard of care and in line with the current local labeling in Korea.
Key inclusion criteria (1 listed)
- All patients administered Herceptin SC for the locally approved indications
Key exclusion criteria (1 listed)
- N/A
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 adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs
Time frame: Up to 6 years
2 secondary outcomes
Efficacy: Pathological Complete Response (pCR) in neoadjuvant early breast cancer (EBC)
Time frame: Up to 6 years
Efficacy: Overall response per Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Up to 6 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 16 Nov 2020.
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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
23 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 23 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 1 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 16 Nov 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 23 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 adverse events (AEs), serious adverse events (SAEs), adverse events of special interest, pregnancies, adverse drug reactions (ADRs); unexpected ADRs; expected ADRs (time frame: Up to 6 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 16 Nov 2020.