NCT03025711

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

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
220

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Dec 2017

Typical duration for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

January 11, 2017

Completed
8 days until next milestone

First Posted

Study publicly available on registry

January 19, 2017

Completed
11 months until next milestone

Study Start

First participant enrolled

December 1, 2017

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2018

Completed
1.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

January 31, 2020

Completed
Last Updated

March 5, 2020

Status Verified

March 1, 2020

Enrollment Period

10 months

First QC Date

January 11, 2017

Last Update Submit

March 4, 2020

Conditions

Breast Neoplasms

Keywords

Advanced HER2+ breast cancerPertuzumabTrastuzumab emtansineCompassionate useEarly access programEffectivenessSafety

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (10)

  • Progression free survival.

    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

    Through study completion, an average of 4 year

  • Duration of response (DOR)

    Through study completion, an average of 4 year

  • Time to treatment failure

    Through study completion (from date of start of treatment until the date of treatment failure, assessed up to 48 months)

  • Time to Objective Response

    Through study completion (from date of start of treatment until the date of the first confirmed response, assessed up to 48 months)

  • +5 more secondary outcomes

Study Arms (2)

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

Eligibility Criteria

Age18 Years - 100 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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.

You may qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Puerta de Hierro University Hospital

Madrid, 28222, Spain

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue Diseases

Study Officials

  • Belén Ruiz-Antorán, PhD

    Department of Clinical Pharmacology, University Hospital Puerta de Hierro Majadahonda, Madrid, Spain

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
RETROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

January 11, 2017

First Posted

January 19, 2017

Study Start

December 1, 2017

Primary Completion

October 1, 2018

Study Completion

January 31, 2020

Last Updated

March 5, 2020

Record last verified: 2020-03

Data Sharing

IPD Sharing
Will not share

Locations

ES(1)