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

BELEN RUIZ-ANTORAN220 enrolled

Overview

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

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

Enrollment

220

Conditions

Breast Neoplasms

Eligibility

Sex: ALLMin age: 18 YearsMax age: 100 Years

Medical Language ↔ Plain English

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.

Locations (1)

Puerta de Hierro University Hospital

Madrid, Spain

Outcomes

Primary Outcomes

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

Time frame: Through study completion (from date of start of treatment until the date of death from any cause, assessed up to 48 months).

Secondary Outcomes

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).

Time frame: Through study completion (from date of start of treatment until the date of first documented progression assessed up to 48 months)

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

Time frame: Through study completion, an average of 4 year

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.

Time frame: Through study completion, an average of 4 year

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

Data from ClinicalTrials.gov

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