A Phase 3 interventional study of Aromatase Inhibitors (Arimidex) and Tamoxifen in Breast Cancer, sponsored by Dharmais National Cancer Center Hospital. Completed at 1 site in Indonesia. Open to female participants, including healthy volunteers. Per ClinicalTrials.gov, last updated 2019-06-19.
Sponsored by Dharmais National Cancer Center Hospital · Phase 3, Interventional, and Treatment
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)
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.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 122 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Dharmais National Cancer Center Hospital is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Exclusion Criteria:
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Drug: Aromatase Inhibitors (Arimidex) · Drug: Tamoxifen · Procedure: SOB · Drug: Aromatase Inhibitors (Femara) · Drug: Aromatase Inhibitors (Aromasin)
Neoadjuvant chemotherapy: FAC 6 cycles
Drug: FAC
Comparison of efficacy with chemotherapy
Also known as: Anastrozole
Comparison of efficacy with chemotherapy
Also known as: Nolvadex, Soltamox
Comparison of efficacy with chemotherapy
Also known as: Salpingo-oophorectomy Bilateral
Comparison of efficacy with hormonal therapy
Also known as: Fluorouracil, Adriamycin, Cytoxan
Comparison of efficacy with chemotherapy
Also known as: Letrozole
Comparison of efficacy with chemotherapy
Also known as: Exemestane
Overall survival
length of time from the date of pathological diagnosis until death from any cause
Time frame: time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years
Progressive free survival
length of time from after treatment until tumor progression or death from any cause
Time frame: time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years
Plan to share: Undecided — We have not decided on this yet
This study is completed, as verified in Jun 2019. You cannot join it, but the record below documents what was studied.
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Dharmais National Cancer Center Hospital