Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients

Study Overview
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Brief Summary
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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
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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.

Official Title
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Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia

Conditions
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Breast Cancer

Intervention / Treatment
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* Drug: Aromatase Inhibitors (Arimidex)
* Drug: Tamoxifen
* Procedure: SOB
* Drug: FAC
* Drug: Aromatase Inhibitors (Femara)
* Drug: Aromatase Inhibitors (Aromasin)


Participation Criteria
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Eligibility Criteria
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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
Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Neoadjuvant hormonal therapy<br>Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen | Drug: Aromatase Inhibitors (Arimidex)<br>* Comparison of efficacy with chemotherapy<br>* Other names: Anastrozole;Drug: Tamoxifen<br>* Comparison of efficacy with chemotherapy<br>* Other names: Soltamox;Procedure: SOB<br>* Comparison of efficacy with chemotherapy<br>* Other names: Salpingo-oophorectomy Bilateral;Drug: Aromatase Inhibitors (Femara)<br>* Comparison of efficacy with chemotherapy<br>* Other names: Letrozole;Drug: Aromatase Inhibitors (Aromasin)<br>* Comparison of efficacy with chemotherapy<br>* Other names: Exemestane;|
| Active Comparator: Neoadjuvant chemotherapy<br>Neoadjuvant chemotherapy: FAC 6 cycles | Drug: FAC<br>* Comparison of efficacy with hormonal therapy<br>* Other names: Fluorouracil, Adriamycin, Cytoxan;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Overall survival | length of time from the date of pathological diagnosis until death from any cause | time from the date of pathological diagnosis until death from any cause and until minimum sample sizes are met and an average 3 years | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Progressive free survival | length of time from after treatment until tumor progression or death from any cause | time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years |