Breast CancerNCT02266173
Observational Study of Pertuzumab Safety in Participants With Breast Cancer
An observational study of Breast Cancer, run by Hoffmann-La Roche at 37 sites in South Korea.
Trial summary
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Pertuzumab
- How many people
- 1,130 participants
- Where
- 37 sitesSouth Korea
- Study dates
- 5 Feb 2015to 8 Mar 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: Adult participants with metastatic or locally unresectable recurrent breast cancer and have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity.
Who may be able to join
- Participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity
- HER2-positive, locally advanced, inflammatory, or early stage breast cancer (greater than [>]2 centimeters [cm] in diameter) participants who have never received chemotherapy and surgery for breast cancer
Who cannot join
- Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
- Contraindications to Perjeta according to SmPC
- Pregnancy and lactation
Trial locations and contacts
37 sites in 1 country.
37 sites in 1 country
South Korea37 sites
Inje university Haeundae Paik Hospital
Busan, 48108
Pusan National University Hospital
Busan, 49241
Kosin University Gospel Hospital
Busan, 49267
Kyungpook National University Chilgok Hospital
Daegu, 41404
Keimyung University Dongsan Medical Center
Daegu, 41931
Chungnam National University Hospital
Daejeon, 35015
National Health Insurance Service Ilsan Hospital
Gyeonggi-do, 10408
Hallym University Sacred Heart Hospital
Gyeonggi-do, 14068
Soonchunhyang University Bucheon Hospital
Gyeonggi-do, 14584
St. Vincent's Hospital
Gyeonggi-do, 16247
Ajou University Medical Center
Gyeonggi-do, 16499
The Catholic University of Korea Bucheon St. Mary's Hospital
Gyeonggi-do
Pusan National University Yangsan Hospital
Gyeongsangnam-do, 50612
Catholic Univ. of Incheon St.Mary's Hospital
Incheon, 21431
Inha University Hospital
Incheon, 22332
Gil Hospital. Gachon University
Incheon, 405-760
Catholic Kwandong University International St. Mary'S Hospital.
Incheon
Chonnam National University Hwasun Hospital
Jeollanam-do, 58128
Wonkwang University School of Medicine & Hospital
Jeonlabuk-do, 54538
Seoul National University Bundang Hospital
Seongnam-si, 13605
Samsung Medical Center
Seoul, (0)6351
Inje University, Sanggye-Paik Hospital
Seoul, 01757
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
Severance Hospital, Yonsei University Health System
Seoul, 03722
Konkuk University Medical Center
Seoul, 05030
Gangdong Kyung Hee University Hospital
Seoul, 05278
Asan Medical Center
Seoul, 05505
Gangnam Severance Hospital
Seoul, 06273
Seoul St Mary's Hospital
Seoul, 06591
ChungAng University Hospital
Seoul, 06973
Yeouido St. Mary's Hospital
Seoul, 07345
Ewha Womans University Mokdong Hospital
Seoul, 07985
Korea University Guro Hospital
Seoul, 08308
SMG-SNU Boramae Medical Center
Seoul, 156-707
Ulsan University Hosiptal
Ulsan, 44033
About this study
Official title: Post-Marketing Surveillance of Perjeta in Breast Cancer
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their metastatic disease with HER2 positivity in Korea. Participants who are administered with pertuzumab according to medical opinions of the doctor in charge of surveillance will be registered for this study and treated with pertuzumab under the approval conditions of the product in Korea.
- Conditions
- Breast Cancer
- Being tested
- Pertuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PertuzumabDrug
Also called Perjeta
Study protocol does not specify/enforce any particular dosage regimen. Pertuzumab will be administered according to standard of care and in line with current SmPC/local labelling.
| Study group | Role | What they receive |
|---|---|---|
| Pertuzumab | Participants for whom the treating physician has decided to administer pertuzumab according to standard of care and in line with the current summary of product characteristics (SmPC)/local labeling, will be observed. Receives: Drug: Pertuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Measured: Baseline up to approximately 6 years
Secondary outcomes (1)
Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST)
Measured: Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 6 years)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Oct 2014 (estimated)
- Study start5 Feb 2015
- Primary completion8 Mar 2021
- Study completion8 Mar 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
- 1,130 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
- NCT02266173
- Sponsor's protocol ID
- ML29299
- Status last verified
- Apr 2021
- First submitted
- 30 Sep 2014
- Last updated
- 3 May 2021
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 3 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Post-Marketing Surveillance of Perjeta in Breast Cancer
- ClinicalTrials.gov ID
- NCT02266173
- Acronym / sponsor ID
- ML29299
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 1,130 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 5 Feb 2015 (actual)
- Primary completion
- 8 Mar 2021 (actual)
- Study completion
- 8 Mar 2021 (actual)
- First posted
- 16 Oct 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 Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 1000 participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-human epidermal growth factor receptor 2 (HER2) therapy for their metastatic disease with HER2 positivity in Korea. Participants who are administered with pertuzumab according to medical opinions of the doctor in charge of surveillance will be registered for this study and treated with pertuzumab under the approval conditions of the product in Korea.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Pertuzumab | – | Drug: PertuzumabParticipants for whom the treating physician has decided to administer pertuzumab according to standard of care and in line with the current summary of product characteristics (SmPC)/local labeling, will be observed. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Adult participants with metastatic or locally unresectable recurrent breast cancer and have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity.
Key inclusion criteria (2 listed)
- Participants with metastatic or locally unresectable recurrent breast cancer who have never received chemotherapy or anti-HER2 therapy for metastatic disease with HER2 positivity
- HER2-positive, locally advanced, inflammatory, or early stage breast cancer (greater than [>]2 centimeters [cm] in diameter) participants who have never received chemotherapy and surgery for breast cancer
Key exclusion criteria (3 listed)
- Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
- Contraindications to Perjeta according to SmPC
- Pregnancy and lactation
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 |
|---|---|---|
| PertuzumabAlso: PerjetaStudy protocol does not specify/enforce any particular dosage regimen. Pertuzumab will be administered according to standard of care and in line with current SmPC/local labelling. | Drug | Pertuzumab |
Primary outcome
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs)
Time frame: Baseline up to approximately 6 years
1 secondary outcome
Percentage of Participants With Overall Response as Determined Using Response Evaluation Criteria in Solid Tumors (RECIST)
Time frame: Baseline until disease progression or death, whichever occurs earlier (assessed up to approximately 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 3 May 2021.
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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
37 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 37 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 2 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 3 May 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 37 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?
Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) (time frame: Baseline up to approximately 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 3 May 2021.