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Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine (KNOWHER)

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ClinicalTrials.gov Identifier: NCT03025711
Recruitment Status : Recruiting
First Posted : January 19, 2017
Last Update Posted : January 31, 2019
Sponsor:
Information provided by (Responsible Party):
BELEN RUIZ-ANTORAN, Puerta de Hierro University Hospital

Tracking Information
First Submitted Date January 11, 2017
First Posted Date January 19, 2017
Last Update Posted Date January 31, 2019
Actual Study Start Date December 1, 2017
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 16, 2017)
Overall survival. [ Time Frame: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months). ]
The time between the date of start of treatment and the date of death. For subjects without documentation of death, OS will be censored on the last date the subject was known to be alive
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03025711 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 16, 2017)
  • Progression free survival. [ Time Frame: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months) ]
    The time from start of treatment to the date of the first documented tumour progression as determined by the clinician (may be based on clinical examination or radiographic or laboratory features).
  • Best overall response rate [ Time Frame: Through study completion, an average of 4 year ]
    Response rate is defined as the proportion of patients with complete response (CR) or partial response (PR) based on their best overall response as written in the medical record
  • Duration of response (DOR) [ Time Frame: Through study completion, an average of 4 year ]
    The time between the date of first confirmed response to the date of the first documented tumour progression, or death due to any cause, whichever occurs first. At the time of the analysis, several limitations should be taken into consideration for this retrospective study: DOR is only appraisable if measurable disease and DOR data availability in the medical records (ideally assessed with the RECIST criteria) could be incomplete.
  • Time to treatment failure [ Time Frame: Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months) ]
  • Time to Objective Response [ Time Frame: Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months) ]
    The time from start of treatment to the date of the first confirmed response (evaluated for responders only)
  • Time to change treatment [ Time Frame: Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months) ]
  • Time to next treatment [ Time Frame: Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months) ]
  • All suspected Grade 3/4/5 adverse reactions [ Time Frame: Through study completion, an average of 4 year ]
  • Adverse events of special interest to anti HER2 Mab (AESI) [ Time Frame: Through study completion, an average of 4 year ]
    • AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration)
    • AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease
  • AEs of scientific interest [ Time Frame: Through study completion, an average of 4 year ]
    • An asymptomatic decline in LVEF requiring treatment or leading to discontinuation of study treatment (regarding treatment with T-DM1 and Pertuzumab)
    • Other AEs leading to treatment discontinuation
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Outcomes Of The Spanish Cohort Of Early Access To Pertuzumab And Trastuzumab Emtansine
Official Title Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer
Brief Summary The overall study objective is to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab under real-world disease conditions in the Spain, and specifically in patients treated under compassionate use or early access program
Detailed Description

This is a retrospective, non-interventional, non-comparative, observational cohort study / registry in the Spain. The study design will reflect real-life clinical management of patients with HER2-positive MBC. Type and frequency of actual patient visits and all evaluations will be done as for routine clinical practice.

The analysis of the efficacy and safety results obtained in patients receiving pertuzumab or TDM1 in those early access systems is of utmost importance. These real-world patients with advanced breast cancer may have different characteristics than those enrolled in clinical trials and clinicians must often extrapolate into therapeutic decisions not fully supported by a robust evidence.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Retrospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population This study will include a cohort of approximately 700 adult patients from the Spain with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab under compassionate use or early access program. The decision to initiate use of Trastuzumab emtansine (T-DM1) and Pertuzumab is made independently by the participant and their health care provider and is not mandated by the study design or protocol.
Condition Breast Neoplasms
Intervention Not Provided
Study Groups/Cohorts
  • Pertuzumab
    Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Pertuzumab under Spanish compassionate use or early access program
  • Trastuzumab emtansine
    Patients with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) under Spanish compassionate use or early access program
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 16, 2017)
700
Original Estimated Enrollment Same as current
Estimated Study Completion Date July 31, 2019
Actual Primary Completion Date October 1, 2018   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Adult patients (age ≥ 18 years at enrolment) with HER2-positive metastatic or locally recurrent unresectable breast cancer and who are treated with Trastuzumab emtansine (T-DM1) or Pertuzumab.
  • Patients who initiate Trastuzumab emtansine (T-DM1) and Pertuzumab under Spanish compassionate use or early access program.

Exclusion Criteria:

  • Given the characteristics of the study there are no exclusion criteria.
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 100 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Belén Ruiz-Antorán 911917479 mariabelen.ruiz@salud.madrid.org
Listed Location Countries Spain
Removed Location Countries  
 
Administrative Information
NCT Number NCT03025711
Other Study ID Numbers ML29844
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement
Plan to Share IPD: No
Responsible Party BELEN RUIZ-ANTORAN, Puerta de Hierro University Hospital
Study Sponsor BELEN RUIZ-ANTORAN
Collaborators Not Provided
Investigators
Principal Investigator: Belén Ruiz-Antorán, PhD Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain
PRS Account Puerta de Hierro University Hospital
Verification Date January 2019