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A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization

NCT07527741

RecruitingN/A

Sponsor: Hoffmann-La Roche

Conditions: Early-stage HER2+ Breast Cancer

Countries: Serbia

The main purpose of this study is to evaluate the impact of a decentralized treatment model on treatment adherence in participants with early-stage human epidermal growth factor receptor 2- positive (HER2+) breast cancer (BC). This study has 2 groups: Group 1: Consistent Travel Burden (Cohorts A, C, and D), will include participants whose adjuvant therapy location does not increase their travel requirements, and Group 2: Increased Travel Burden (Cohort B), will include participants who must travel from a secondary center to a tertiary center to receive their adjuvant therapy.

Eligibility overview

Sex: FEMALE

Age: 18 Years to —

Healthy volunteers: No

Study type: OBSERVATIONAL

Eligibility criteria

Inclusion Criteria:

* Diagnosis of stage II and III HER2+ eBC according to European Society For Medical Oncology (ESMO) guidelines
* Underwent curative-intent surgical resection for BC
* Histologically documented HER2-positive BC (determined per American Society of Clinical Oncology \[ASCO\]/College of American Pathologists \[CAP\] guidelines) before or after surgery

Exclusion Criteria:

* Any medical or psychiatric condition that, in the investigator's opinion, would compromise the participant's ability to provide informed consent or to complete study-related questionnaires
* Receipt of prior neoadjuvant or adjuvant therapy for HER2+ BC at a center other than the 10 participating study sites (Bor, Kladovo, Institute for oncology and Radiology of Serbia (IORS), Loznica, Pančevo, Požarevac, Smederevo, Smederevska Palanka, Šabac, Valjevo)
* Participants administratively belonging to the following secondary centers: Bor, Kladovo, Loznica, Pančevo, Požarevac, Smederevo, Smederevska Palanka, Šabac, or Valjevo, who initiated neoadjuvant therapy at IORS instead of their local secondary center

Locations (10)

Loznica, Bolnička 65, Serbia
Požarevac, Bratstva Jedinstva 135, Serbia
Bor, Dragiše Mišovića 1, Serbia
Kladovo, Dunavska 1-3, Serbia
Smederevo, Knez Mihailova 51, Serbia
Pančevo, Miloša Trebinjca 11, Serbia
Belgrade, Pasterova 14, Serbia
Šabac, Popa Karana 2-4, Serbia
Valjevo, Sinđelićeva 62, Serbia
Smederevska Palanka, Vuka Karadžića 147, Serbia