Trial | NCT02995772  Report issue

Title

Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients
Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia

  • Phase

    Phase 3

  • Study Type

    Interventional

  • Status

    Completed No Results Posted

  • Study Participants

    122
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.
Study Started
Nov 30
2011
Primary Completion
Nov 30
2018
Study Completion
Nov 30
2018
Last Update
Jun 19
2019

Drug Aromatase Inhibitors (Arimidex)

Comparison of efficacy with chemotherapy

  • Other names: Anastrozole

Drug Tamoxifen

Comparison of efficacy with chemotherapy

  • Other names: Nolvadex, Soltamox

Procedure SOB

Comparison of efficacy with chemotherapy

  • Other names: Salpingo-oophorectomy Bilateral

Drug FAC

Comparison of efficacy with hormonal therapy

  • Other names: Fluorouracil, Adriamycin, Cytoxan

Drug Aromatase Inhibitors (Femara)

Comparison of efficacy with chemotherapy

  • Other names: Letrozole

Drug Aromatase Inhibitors (Aromasin)

Comparison of efficacy with chemotherapy

  • Other names: Exemestane

Neoadjuvant hormonal therapy Active Comparator

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

Neoadjuvant chemotherapy Active Comparator

Neoadjuvant chemotherapy: FAC 6 cycles

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
pregnant
disagree to enter the study
had been given hormonal therapy or chemotherapy before study
had contra-indication of SOB for pre-menopausal patients
No Results Posted