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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

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

Condition or disease
Breast Neoplasms

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.


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Study Type : Observational
Estimated Enrollment : 700 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer
Actual Study Start Date : December 1, 2017
Actual Primary Completion Date : October 1, 2018
Estimated Study Completion Date : July 31, 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Group/Cohort
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



Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. 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).

  2. 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

  3. 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.

  4. 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) ]
  5. 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)

  6. 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) ]
  7. 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) ]
  8. All suspected Grade 3/4/5 adverse reactions [ Time Frame: Through study completion, an average of 4 year ]
  9. 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

  10. 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



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 100 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
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.

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): NCT03025711


Contacts
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Contact: Belén Ruiz-Antorán 911917479 mariabelen.ruiz@salud.madrid.org

Locations
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Spain
Puerta de Hierro University Hospital Recruiting
Madrid, Spain, 28222
Contact: Belen Ruiz-Antoran    34911917479    mariabelen.ruiz@salud.madrid.org   
Principal Investigator: Belen Ruiz-Antorán         
Sponsors and Collaborators
BELEN RUIZ-ANTORAN
Investigators
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Principal Investigator: Belén Ruiz-Antorán, PhD Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain

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Responsible Party: BELEN RUIZ-ANTORAN, Principal Investigator, Puerta de Hierro University Hospital
ClinicalTrials.gov Identifier: NCT03025711     History of Changes
Other Study ID Numbers: ML29844
First Posted: January 19, 2017    Key Record Dates
Last Update Posted: January 31, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Keywords provided by BELEN RUIZ-ANTORAN, Puerta de Hierro University Hospital:
Advanced HER2+ breast cancer
Pertuzumab
Trastuzumab emtansine
Compassionate use
Early access program
Effectiveness
Safety
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Trastuzumab
Pertuzumab
Ado-trastuzumab emtansine
Maytansine
Antineoplastic Agents, Immunological
Antineoplastic Agents
Antineoplastic Agents, Phytogenic
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Molecular Mechanisms of Pharmacological Action