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

June 16, 2019 updated by: Dharmais National Cancer Center Hospital

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

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)

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

122

Phase

  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Indonesia
      • Jakarta, Indonesia, 11420
        • Dharmais National Cancer Center Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

Female

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

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

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
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: Aromatase Inhibitors (Femara)
Comparison of efficacy with chemotherapy
Other Names:
  • Letrozole
Drug: Aromatase Inhibitors (Aromasin)
Comparison of efficacy with chemotherapy
Other Names:
  • Exemestane
Active Comparator: Neoadjuvant chemotherapy
Neoadjuvant chemotherapy: FAC 6 cycles
Drug: FAC
Comparison of efficacy with hormonal therapy
Other Names:
  • Fluorouracil, Adriamycin, Cytoxan

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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
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
time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Dharmais National Cancer Center Hospital

Investigators

  • Study Chair: Ramadhan Karsono, Doctoral, Dharmais National Cancer Center Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2011

Primary Completion (Actual)

November 1, 2018

Study Completion (Actual)

November 1, 2018

Study Registration Dates

First Submitted

December 14, 2016

First Submitted That Met QC Criteria

December 14, 2016

First Posted (Estimate)

December 16, 2016

Study Record Updates

Last Update Posted (Actual)

June 19, 2019

Last Update Submitted That Met QC Criteria

June 16, 2019

Last Verified

June 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 049/PEP/08/2011

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

IPD Plan Description

We have not decided on this yet

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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