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

NCT02995772 | Completed Phase 3

• 1 other identifier: 049/PEP/08/2011
• Study Type: interventional
• Target: 122
• Locations: 1 country
• Sites: 1

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)

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Overall survival

  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 Outcomes (1)

• Progressive free survival

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

Study Arms (2)

Neoadjuvant hormonal therapy

ACTIVE COMPARATOR

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

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

Neoadjuvant chemotherapy

ACTIVE COMPARATOR

Neoadjuvant chemotherapy: FAC 6 cycles

Drug: FAC

Interventions

Aromatase Inhibitors (Arimidex) DRUG

Comparison of efficacy with chemotherapy

Also known as: Anastrozole

Neoadjuvant hormonal therapy

Tamoxifen DRUG

Comparison of efficacy with chemotherapy

Also known as: Nolvadex, Soltamox

Neoadjuvant hormonal therapy

SOB PROCEDURE

Comparison of efficacy with chemotherapy

Also known as: Salpingo-oophorectomy Bilateral

Neoadjuvant hormonal therapy

FAC DRUG

Comparison of efficacy with hormonal therapy

Also known as: Fluorouracil, Adriamycin, Cytoxan

Neoadjuvant chemotherapy

Aromatase Inhibitors (Femara) DRUG

Comparison of efficacy with chemotherapy

Also known as: Letrozole

Neoadjuvant hormonal therapy

Aromatase Inhibitors (Aromasin) DRUG

Comparison of efficacy with chemotherapy

Also known as: Exemestane

Neoadjuvant hormonal therapy

Eligibility Criteria

• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• IIIB/C and IV stage of breast cancer
• received neoadjuvant hormonal therapy or neoadjuvant chemotherapy
• had first and second biopsy (surgery) within 6 months

You may not qualify if:

• 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

Sponsors & Collaborators

• Dharmais National Cancer Center Hospital: lead

Study Sites (1)

Dharmais National Cancer Center Hospital

Jakarta, 11420, Indonesia

Location

Related Publications (24)

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MeSH Terms

Conditions

Breast Neoplasms

Interventions

Aromatase Inhibitors; Anastrozole; Tamoxifen; Fluorouracil; Doxorubicin; Cyclophosphamide; Letrozole; exemestane

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Steroid Synthesis Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action; Pharmacologic Actions; Chemical Actions and Uses; Estrogen Antagonists; Hormone Antagonists; Hormones, Hormone Substitutes, and Hormone Antagonists; Physiological Effects of Drugs; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Uracil; Pyrimidinones; Pyrimidines; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Polycyclic Compounds; Aminoglycosides; Glycosides; Carbohydrates; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Phosphoramides; Organophosphorus Compounds

Study Officials

• Ramadhan Karsono, Doctoral

  Dharmais National Cancer Center Hospital

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 14, 2016
• First Posted: December 16, 2016
• Study Start: November 1, 2011
• Primary Completion: November 1, 2018
• Study Completion: November 1, 2018
• Last Updated: June 19, 2019

Record last verified: 2019-06

Locations

ID (1)