Status:

COMPLETED

An Observational Study of the Safety of Herceptin Given Subcutaneously in Patients With Early HER2-positive Breast Cancer

Lead Sponsor:

Hoffmann-La Roche

Conditions:

Breast Cancer

Eligibility:

FEMALE

18+ years

Brief Summary

This non-interventional prospective study will assess the safety of Herceptin SC (subcutaneous administration) as used in routine clinical practice. Patients with HER2-positive early breast cancer, na...

Eligibility Criteria

Inclusion

  • Aged \>/= 18 years
  • Patients with HER2-positive early breast cancer who according to national guidelines are eligible for neoadjuvant or adjuvant HER2+ treatment
  • Patients for whom the investigator has decided to start a treatment with Herceptin SC
  • Trastuzumab treatment naive or non-naive (previously intravenous treatment)
  • Informed consent

Exclusion

  • Patients previously treated with Herceptin SC treatment

Key Trial Info

Start Date :

January 14 2015

Trial Type :

OBSERVATIONAL

Allocation :

ACTUAL

End Date :

November 10 2016

Estimated Enrollment :

510 Patients enrolled

Trial Details

Trial ID

NCT02286362

Start Date

January 14 2015

End Date

November 10 2016

Last Update

September 27 2017

Active Locations (97)

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Page 1 of 25 (97 locations)

1

Clinique Du Docteur Calabet; Cromg

Agen, France, 47000

2

C H Du Pays D'Aix En Provence; Hopital De Jour

Aix-en-Provence, France, 13616

3

Ch Du Pays D Aix; Maternite Gynecologie

Aix-en-Provence, France, 13616

4

Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire

Aix-en-Provence, France, 13617