Breast Cancer
Conditions
Brief summary
This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT)
Detailed description
This study compared long term outcome of stage IIIB/C and IV breast cancer patients treated with neoadjuvant hormonal therapy (NAHT) and those treated with neoadjuvant chemotherapy (NACT) between 2011 and 2016. The primary end points are overall survival (OS) and progression free survival (PFS) with Kaplan Meier. This study was approved by Ethical Committee in Dharmais National Cancer Hospital.
Interventions
DRUGAromatase Inhibitors (Aromasin)
Comparison of efficacy with chemotherapy
DRUGAromatase Inhibitors (Arimidex)
Comparison of efficacy with chemotherapy
DRUGTamoxifen
Comparison of efficacy with chemotherapy
PROCEDURESOB
Comparison of efficacy with chemotherapy
DRUGFAC
Comparison of efficacy with hormonal therapy
DRUGAromatase Inhibitors (Femara)
Comparison of efficacy with chemotherapy
Sponsors
Dharmais National Cancer Center Hospital
Study design
Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Healthy volunteers
Yes
Inclusion criteria
* IIIB/C and IV stage of breast cancer * received neoadjuvant hormonal therapy or neoadjuvant chemotherapy * had first and second biopsy (surgery) within 6 months
Exclusion criteria
* had mastectomy before treatment * pregnant * disagree to enter the study * had been given hormonal therapy or chemotherapy before study * had contra-indication of SOB for pre-menopausal patients
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Overall survival | time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years | length of time from the date of pathological diagnosis until death from any cause |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Progressive free survival | time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years | length of time from after treatment until tumor progression or death from any cause |
Countries
Indonesia
Outcome results
None listed