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Completed

NCT Number: NCT02995772

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

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)

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Key information

Conditions

Breast Cancer Breast Diseases Breast Neoplasms Neoplasms Neoplasms by Site Skin Diseases Skin and Connective Tissue Diseases

Sex eligibility

Female

Study type

Interventional

Phase

Phase 3

Primary location

Dharmais National Cancer Center Hospital

Jakarta, 11420, Indonesia

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Aromatase Inhibitors (Arimidex)

Drug

Comparison of efficacy with chemotherapy

Other names: Anastrozole

Tamoxifen

Drug

Comparison of efficacy with chemotherapy

Other names: Nolvadex, Soltamox

SOB

Procedure

Comparison of efficacy with chemotherapy

Other names: Salpingo-oophorectomy Bilateral

FAC

Drug

Comparison of efficacy with hormonal therapy

Other names: Fluorouracil, Adriamycin, Cytoxan

Aromatase Inhibitors (Femara)

Drug

Comparison of efficacy with chemotherapy

Other names: Letrozole

Aromatase Inhibitors (Aromasin)

Drug

Comparison of efficacy with chemotherapy

Other names: Exemestane

Primary outcomes

  1. 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

  1. Progressive free survival

    Time frame: 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

Sponsors and collaborators

Lead sponsor

Dharmais National Cancer Center Hospital

Other Gov

Registry information

Official study title

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

Important dates

Study start
2011
Primary completion
2018
Study completion
2018
First posted
Dec 16, 2016
Registry last updated
Jun 19, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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