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

Dharmais National Cancer Center Hospital

Status and phase: Completed; Phase 3

Conditions: Breast Cancer

Treatments: Drug: Aromatase Inhibitors (Arimidex); Drug: Aromatase Inhibitors (Femara); Procedure: SOB; Drug: FAC; Drug: Aromatase Inhibitors (Aromasin); Drug: Tamoxifen

Study type: Interventional

Funder types: Other

Identifiers

NCT02995772

049/PEP/08/2011

Details and patient eligibility

About

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)

Full 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.

Enrollment: 122 patients

Sex: Female

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Non-Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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122 participants in 2 patient groups

Neoadjuvant hormonal therapy

Active Comparator group

Description:

Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen

Treatment:

Drug: Tamoxifen

Drug: Aromatase Inhibitors (Aromasin)

Procedure: SOB

Drug: Aromatase Inhibitors (Femara)

Drug: Aromatase Inhibitors (Arimidex)

Neoadjuvant chemotherapy

Active Comparator group

Description:

Neoadjuvant chemotherapy: FAC 6 cycles

Treatment:

Drug: FAC