Breast Cancer
Conditions
Brief summary
This observational study, conducted by the Kenya Society for Hematology and Oncology, will develop a Breast Cancer and Care Registry (BRECC) for Kenya. Data on demographic, clinical and pathological characteristics, treatment and clinical outcome will be collected from newly diagnosed breast cancer patients. Breast cancer patients will be recruited into this registry cohort and followed up for a period of not less than five years.
Interventions
None listed
Sponsors
Hoffmann-La Roche
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Histologically or cytologically confirmed breast cancer * No previous interventional therapy for breast cancer * Ability to provide written informed consent as per GCP and local regulations
Exclusion criteria
* Participation in other clinical study where the diagnosis and treatment protocol is stated prior to enrolment * Inability to assess and follow up patient outcomes, for example quality of life due to psychiatric illness or WHO/ECOG performance status IV or worse
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence of breast cancer in Kenya | 5 years |
| Breast cancer treatment patterns (drugs/dosage/schedule) in clinical practice in Kenya | 5 years |
Secondary
| Measure | Time frame |
|---|---|
| Patient demographics of breast cancer patients in Kenya | 5 years |
| Pathology: Prevalence of tumour types | 5 years |
| Progression-free survival | 5 years |
| Therapy duration/compliance | 5 years |
| Safety: Incidence of adverse events | 5 years |
| Correlation between risk factors and clinical outcome | 5 years |
| Overall survival | 5 years |
Countries
Kenya
Outcome results
None listed