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

Breast Neoplasms Clinical Trial

— KNOWHER  

Official title:

Use Of Pertuzumab And Trastuzumab Emtansine In Adult Patients With Her2-Positive Metastatic Or Locally Recurrent Unresectable Breast Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03025711
• Other study ID #: ML29844
• Status: Completed
• Start date: December 1, 2017
• Est. completion date: January 31, 2020

Study information

• Verified date: March 2020
• Source: Puerta de Hierro University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 220
• Est. completion date: January 31, 2020
• Est. primary completion date: October 1, 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 100 Years

Eligibility

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.

Related Conditions & MeSH terms

• Breast Neoplasms

Locations

Country	Name	City	State
Spain	Puerta de Hierro University Hospital	Madrid

Sponsors (1)

Lead Sponsor	Collaborator
BELEN RUIZ-ANTORAN

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Overall survival.	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	Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).
Secondary	Progression free survival.	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).	Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)
Secondary	Best overall response rate	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	Through study completion, an average of 4 year
Secondary	Duration of response (DOR)	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.	Through study completion, an average of 4 year
Secondary	Time to treatment failure		Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)
Secondary	Time to Objective Response	The time from start of treatment to the date of the first confirmed response (evaluated for responders only)	Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)
Secondary	Time to change treatment		Through study completion (from date of start of treatment until the date of change treatment, assessed up to 48 months)
Secondary	Time to next treatment		Through study completion (from date of start of treatment until the date of start other treatment, assessed up to 48 months)
Secondary	All suspected Grade 3/4/5 adverse reactions		Through study completion, an average of 4 year
Secondary	Adverse events of special interest to anti HER2 Mab (AESI)	AESIs regarding treatment with T-DM1: Hepatic disorder (specific analytical alteration); AESIs regarding treatment with Pertuzumab: Interstitial Lung Disease	Through study completion, an average of 4 year
Secondary	AEs of scientific interest	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	Through study completion, an average of 4 year