Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia
Overview
- Phase
- Phase 3
- Intervention
- Aromatase Inhibitors (Arimidex)
- Conditions
- Breast Cancer
- Sponsor
- Dharmais National Cancer Center Hospital
- Enrollment
- 122
- Locations
- 1
- Primary Endpoint
- Overall survival
- Status
- Completed
- Last Updated
- 6 years ago
Overview
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.
Investigators
Eligibility Criteria
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
- •disagree to enter the study
- •had been given hormonal therapy or chemotherapy before study
- •had contra-indication of SOB for pre-menopausal patients
Arms & Interventions
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Intervention: Aromatase Inhibitors (Arimidex)
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Intervention: Tamoxifen
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Intervention: SOB
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Intervention: Aromatase Inhibitors (Femara)
Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Intervention: Aromatase Inhibitors (Aromasin)
Neoadjuvant chemotherapy
Neoadjuvant chemotherapy: FAC 6 cycles
Intervention: FAC
Outcomes
Primary Outcomes
Overall survival
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
length of time from the date of pathological diagnosis until death from any cause
Secondary Outcomes
- 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)