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

Status

Recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTIS

Registry ID

CTIS2022-502706-33-00

Acronym

GEICAM/2016-03

Enrollment

8000

Registered

2023-07-24

Start date

2018-01-10

Completion date

Unknown

Last updated

2025-07-16

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

Brief summary

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.

Detailed description

Death date and whether or not it is related to breast cancer. Overall Survival (OS).

Interventions

DRUGOfev 100 mg soft capsules

DRUGAromasil 25 mg comprimidos recubiertos

DRUGLAPATINIB

DRUGTAXOTERE 20 mg/0.5 ml concentrate and solvent for solution for infusion

DRUGHerceptin 150 mg powder for concentrate for solution for infusion

DRUGAbraxane 5 mg/ml powder for dispersion for infusion.

DRUGXeloda 500 mg film-coated tablets

DRUGFaslodex 250 mg solution for injection.

DRUGCarboplatin 10 mg/ml Concentrate for Solution for Infusion

DRUGZoladex 3

DRUG6 mg implante en jeringa precargada

DRUGPaclitaxel Hospira 6 mg/ml concentrado para solución para perfusión EFG

DRUGGemcitabina Accord 2000 mg polvo para solución para perfusión

DRUGMyocet liposomal 50 mg powder

DRUGdispersion and solvent for concentrate for dispersion for infusion.

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Design outcomes

Primary

Measure	Time frame
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.	—

Secondary

Measure	Time frame
Death date and whether or not it is related to breast cancer. Overall Survival (OS).	—

Countries

Spain

Outcome results

None listed

Source: EU CTIS · Data processed: Feb 4, 2026