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

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ClinicalTrials.gov Identifier: NCT02995772
Recruitment Status : Recruiting
First Posted : December 16, 2016
Last Update Posted : November 22, 2018
Sponsor:
Information provided by (Responsible Party):
Dharmais National Cancer Center Hospital

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 107 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
Study Start Date : August 2011
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : January 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

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




Primary Outcome Measures :
  1. Overall survival [ Time Frame: until minimum sample sizes are met ]

Secondary Outcome Measures :
  1. Progressive free survival [ Time Frame: until minimum sample sizes are met ]


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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

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


Contacts
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Contact: Ramadhan Ramli, PhD +62-812-1045-970 ramadhan@dharmais-surgonc.com

Locations
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Indonesia
Dharmais National Cancer Center Hospital Recruiting
Jakarta, Indonesia, 11420
Contact: Ramadhan Ramli, PhD    +62-812-1045-970    ramadhan@dharmais-surgonc.com   
Sponsors and Collaborators
Dharmais National Cancer Center Hospital
Investigators
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Study Chair: Ramadhan Karsono, Doctoral Dharmais National Cancer Center Hospital

Publications of Results:
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Responsible Party: Dharmais National Cancer Center Hospital
ClinicalTrials.gov Identifier: NCT02995772     History of Changes
Other Study ID Numbers: 049/PEP/08/2011
First Posted: December 16, 2016    Key Record Dates
Last Update Posted: November 22, 2018
Last Verified: November 2018
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
Anastrozole
Letrozole
Exemestane
Aromatase Inhibitors
Estrogen Antagonists
Hormone Antagonists
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents
Steroid Synthesis Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action