Breast Cancer
Conditions
Brief summary
This disease registry is a prospective, multicenter non-interventional study designed to observe the different anticancer treatment regimens and their sequencing throughout the course of the disease in participants with unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (mBC) and to describe the clinical outcome for each treatment regimen measured as progression-free survival.
Interventions
OTHERNo intervention
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Initially diagnosed with HER2-positive unresectable LABC or mBC no more than 6 months prior to enrollment, although they can have received anti-cancer treatment during that time * Able and willing to provide written informed consent and to comply with the study protocol
Exclusion criteria
\- There are no
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants Receiving Each Unique Treatment Regimen Overall | Baseline up to approximately 8 years | — |
| Percentage of Participants Receiving Each Unique Treatment Regimen as First-Line Versus Subsequent-Line Therapy | Baseline up to approximately 8 years | — |
| Percentage of Participants Receiving Each Unique Treatment Regimen Sequence | Baseline up to approximately 8 years | — |
| Progression-Free Survival | From start date of anti-cancer treatment regimen to the date of either disease progression or death (up to approximately 8 years) | Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Percentage of Participants With Objective Response of Complete Response (CR) or Partial Response (PR) | From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) | Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment. |
| Duration of Response (DoR) | From date of first response (CR or PR) to the date of disease progression (up to approximately 8 years) | Tumor response will be evaluated by the Investigator according to site-specific medical practice. Study protocol does not specify any particular method of assessment. |
| Time to Treatment Failure | From the date of initiation of treatment to the date of treatment stopped or switched or death from any cause (up to approximately 8 years) | — |
| Percentage of Participants With Central Nervous System (CNS) as First Site of Progression | From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) | — |
| Percentage of Participants With Adverse Events (AEs) and Serious AEs (SAEs) | Baseline up to approximately 8 years | — |
| Percentage of Participants by Reasons for Treatment Modification | Baseline up to approximately 8 years | — |
| Euro Quality of Life 5-Dimension Questionnaire (EQ-5D) Score | Baseline up to approximately 8 years (assessed every 3 months) | — |
| Number of Treatment Regimens Received | Baseline up to approximately 8 years | — |
| Percentage of Participants with Different Anti-Cancer Treatment Regimens by Country | Baseline up to approximately 8 years | — |
| Percentage of Participants with History of Breast Cancer by Different Anti-Cancer Treatment Regimens | Baseline up to approximately 8 years | — |
| Percentage of Participants with CNS-only Disease Progression | From the date of initiation of treatment to the date of disease progression or death from any cause (up to approximately 8 years) | — |
| Percentage of Participants with Oligometastatic Disease Categorized by Different Anti-Cancer Treatment Regimens | Baseline up to approximately 8 years | — |
| Percentage of Participants Receiving Each Treatment Regimen Categorized by Participant Characteristics | Baseline up to approximately 8 years | — |
| Functional Assessment of Cancer Therapy-Breast (FACT-B) Questionnaire Score | Baseline up to approximately 8 years (assessed every 3 months) | — |
| Work Productivity and Activity Impairment (WPAI) Questionnaire Score | Baseline up to approximately 8 years (assessed every 3 months) | — |
| Overall Survival (OS) | From the date of initiation of treatment to the date of death from any cause (up to approximately 8 years) | — |
Countries
United Kingdom
Outcome results
None listed