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Observational Study of Pertuzumab Safety in Participants With Breast Cancer

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02266173
Recruitment Status : Recruiting
First Posted : October 16, 2014
Last Update Posted : September 21, 2020
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche

Brief Summary:
This Phase IV, prospective, multicenter, non-interventional study (regulatory post-marketing surveillance) will evaluate the safety of pertuzumab in approximately 3000 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.

Condition or disease Intervention/treatment
Breast Cancer Drug: Pertuzumab

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Study Type : Observational
Estimated Enrollment : 1000 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Post-Marketing Surveillance of Perjeta in Breast Cancer
Actual Study Start Date : February 5, 2015
Estimated Primary Completion Date : May 28, 2021
Estimated Study Completion Date : May 28, 2021

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer
Drug Information available for: Pertuzumab

Group/Cohort Intervention/treatment
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.
Drug: Pertuzumab
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.
Other Name: Perjeta




Primary Outcome Measures :
  1. Percentage of Participants With Adverse Events (AEs) and Serious Adverse Events (SAEs) [ Time Frame: Baseline up to approximately 6 years ]

Secondary Outcome Measures :
  1. 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) ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
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.
Criteria

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • Hypersensitivity for pertuzumab (Perjeta) or any of its excipients
  • Contraindications to Perjeta according to SmPC
  • Pregnancy and lactation

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02266173


Contacts
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Contact: Reference Study ID Number: ML29299 www.roche.com/about_roche/roche_worldwide.htm 888-662-6728 (U.S. and Canada) global-roche-genentech-trials@gene.com

Locations
Show Show 39 study locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
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Study Director: Clinical Trials Hoffmann-La Roche
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Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT02266173    
Other Study ID Numbers: ML29299
First Posted: October 16, 2014    Key Record Dates
Last Update Posted: September 21, 2020
Last Verified: September 2020
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pertuzumab
Antineoplastic Agents, Immunological
Antineoplastic Agents