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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02995772
Recruitment Status : Completed
First Posted : December 16, 2016
Last Update Posted : June 19, 2019
Sponsor:
Information provided by (Responsible Party):
Dharmais National Cancer Center Hospital

Study Description
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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)

Condition or disease Intervention/treatment Phase
Breast Cancer Drug: Aromatase Inhibitors (Arimidex) Drug: Tamoxifen Procedure: SOB Drug: FAC Drug: Aromatase Inhibitors (Femara) Drug: Aromatase Inhibitors (Aromasin) Phase 3

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 Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 122 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia
Actual Study Start Date : November 2011
Actual Primary Completion Date : November 2018
Actual Study Completion Date : November 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arms and Interventions
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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 Name: Anastrozole

Drug: Tamoxifen
Comparison of efficacy with chemotherapy
Other Names:
  • Nolvadex
  • Soltamox

Procedure: SOB
Comparison of efficacy with chemotherapy
Other Name: Salpingo-oophorectomy Bilateral

Drug: Aromatase Inhibitors (Femara)
Comparison of efficacy with chemotherapy
Other Name: Letrozole

Drug: Aromatase Inhibitors (Aromasin)
Comparison of efficacy with chemotherapy
Other Name: Exemestane
Active Comparator: Neoadjuvant chemotherapy
Neoadjuvant chemotherapy: FAC 6 cycles
 Drug: FAC
Comparison of efficacy with hormonal therapy
Other Name: Fluorouracil, Adriamycin, Cytoxan


Outcome Measures
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Primary Outcome Measures :
  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 Outcome Measures :
  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


Eligibility Criteria
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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02995772


Locations
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Indonesia
Dharmais National Cancer Center Hospital
Jakarta, Indonesia, 11420
Sponsors and Collaborators
Dharmais National Cancer Center Hospital
Investigators
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Study Chair: Ramadhan Karsono, Doctoral Dharmais National Cancer Center Hospital
More Information
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Publications of Results:

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Responsible Party: Dharmais National Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT02995772    
Other Study ID Numbers: 049/PEP/08/2011
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: June 19, 2019
Last Verified: June 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: We have not decided on this yet
Additional relevant MeSH terms:
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Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Tamoxifen
Fluorouracil
Letrozole
Anastrozole
Exemestane
Aromatase Inhibitors
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
 Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Enzyme Inhibitors
Steroid Synthesis Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Antineoplastic Agents, Hormonal
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents