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

Phase 3

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Aromatase Inhibitors (Arimidex); Drug: FAC; Drug: Tamoxifen; Procedure: SOB; Drug: Aromatase Inhibitors (Femara); Drug: Aromatase Inhibitors (Aromasin)

• Registration Number: NCT02995772
• Lead Sponsor: Dharmais National Cancer Center Hospital

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.

Study Timeline

• Study Start: 2011-11
• Study First Submitted: 2016-12-14
• Study First Submitted QC: 2016-12-14
• Study First Posted: 2016-12-16
• Primary Completion: 2018-11
• Study Completion: 2018-11
• Status Verified: 2019-06
• Last Update Submitted: 2019-06-16
• Last Update Posted: 2019-06-19

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 122

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Neoadjuvant hormonal therapy	Aromatase Inhibitors (Arimidex)	Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Neoadjuvant hormonal therapy	Tamoxifen	Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Neoadjuvant hormonal therapy	SOB	Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Neoadjuvant hormonal therapy	Aromatase Inhibitors (Femara)	Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Neoadjuvant hormonal therapy	Aromatase Inhibitors (Aromasin)	Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Neoadjuvant chemotherapy	FAC	Neoadjuvant chemotherapy: FAC 6 cycles

Primary Outcome Measures

Name	Time	Method
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 Outcome Measures

Name	Time	Method
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

Trial Locations

Locations (1)

Dharmais National Cancer Center Hospital; 🇮🇩 Jakarta, Indonesia