“LONG-TERM FOLLOW-UP STUDY OF EARLY STAGE BREAST CANCER PATIENTS INCLUDED IN GEICAM STUDIES”.

“LONG-TERM FOLLOW-UP STUDY OF EARLY STAGE BREAST CANCER PATIENTS INCLUDED IN GEICAM STUDIES”. - LONG-TERM FOLLOW-UP GEICAM STUDY

Status

Not yet recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2017-002850-35-ES

Enrollment

8000

Registered

2017-10-02

Start date

2017-11-08

Completion date

Unknown

Last updated

2018-01-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Patients with invasive breast cancer in early stages. MedDRA version: 20.0 Level: PT Classification code 10006187 Term: Breast cancer System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)

Interventions

Trade Name: Tyverb Pharmaceutical Form: Film-coated tablet INN or Proposed INN: LAPATINIB CAS Number: 231277-92-2 Concentration unit: mg milligram(s) Concentration type: equal Concentration number: 25

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: 1. Patients included in neoadjuvant and adjuvant clinical trials with GEICAM's participation. If any of these patients had taken part or is participating in another clinical trial, she/he is eligible for this trial and her/his information will also be collected. 2. Patients whose death or contact loss has not been previously collected in the databases of the original studies. Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 4000 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 4000

Exclusion criteria

Exclusion criteria: Patients who were not included in the analyses of the original studies due to non-compliance of the eligibility criteria or the original study informed consent withdrawal.

Design outcomes

Primary

Measure	Time frame
Main Objective: To describe the long-term evolution of the patients with invasive breast cancer in early stages included in GEICAM neoadjuvant and adjuvant clinical trials. Will be studied the frequency, type and location of the first relapse.;Secondary Objective: - Overall survival. - Disease free survival (in adjuvant patients). - Event-free survival (in neoadjuvant patients). - Cause of death.;Primary end point(s): Dates of disease relapse (local, regional or distant) and second primary tumors. Event Free Survival (EvFS) in neoadjuvant studies. Event Free Survival (EFS) in adjuvant studies.;Timepoint(s) of evaluation of this end point: Throughout the whole follow up. Up to 30 years from the begining of the study approximately.	—

Measure

Time frame

Main Objective: To describe the long-term evolution of the patients with invasive breast cancer in early stages included in GEICAM neoadjuvant and adjuvant clinical trials. Will be studied the frequency, type and location of the first relapse.;Secondary Objective: - Overall survival. - Disease free survival (in adjuvant patients). - Event-free survival (in neoadjuvant patients). - Cause of death.;Primary end point(s): Dates of disease relapse (local, regional or distant) and second primary tumors. Event Free Survival (EvFS) in neoadjuvant studies. Event Free Survival (EFS) in adjuvant studies.;Timepoint(s) of evaluation of this end point: Throughout the whole follow up. Up to 30 years from the begining of the study approximately.

—

Secondary

Measure	Time frame
Secondary end point(s): Death date and whether or not it is related to breast cancer. Overall Survival (OS).;Timepoint(s) of evaluation of this end point: Non applicable	—

Countries

Spain

Contacts

Public ContactClinical Operations Department

GEICAM (Fundación Grupo Español de Investigación en Cáncer de Mama)

geicam@geicam.org003491916592870

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026