Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients
NCT ID: NCT02995772
Last Updated: 2019-06-19
Study Results
Results pending
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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Recruitment Status
COMPLETED
Clinical Phase
PHASE3
Total Enrollment
122 participants
Study Classification
INTERVENTIONAL
Study Start Date
2011-11-30
Study Completion Date
2018-11-30
Brief Summary
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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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Detailed Description
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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.
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.
Conditions
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Breast Cancer
Study Design
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Allocation Method
NON_RANDOMIZED
Intervention Model
PARALLEL
Primary Study Purpose
TREATMENT
Blinding Strategy
NONE
Study Groups
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Neoadjuvant hormonal therapy
Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
Group Type
ACTIVE_COMPARATOR
Aromatase Inhibitors (Arimidex)
Intervention Type
DRUG
Comparison of efficacy with chemotherapy
Tamoxifen
Intervention Type
DRUG
Comparison of efficacy with chemotherapy
SOB
Intervention Type
PROCEDURE
Comparison of efficacy with chemotherapy
Aromatase Inhibitors (Femara)
Intervention Type
DRUG
Comparison of efficacy with chemotherapy
Aromatase Inhibitors (Aromasin)
Intervention Type
DRUG
Comparison of efficacy with chemotherapy
Neoadjuvant chemotherapy
Neoadjuvant chemotherapy: FAC 6 cycles
Group Type
ACTIVE_COMPARATOR
FAC
Intervention Type
DRUG
Comparison of efficacy with hormonal therapy
Interventions
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Aromatase Inhibitors (Arimidex)
Comparison of efficacy with chemotherapy
Intervention Type
DRUG
Tamoxifen
Comparison of efficacy with chemotherapy
Intervention Type
DRUG
SOB
Comparison of efficacy with chemotherapy
Intervention Type
PROCEDURE
FAC
Comparison of efficacy with hormonal therapy
Intervention Type
DRUG
Aromatase Inhibitors (Femara)
Comparison of efficacy with chemotherapy
Intervention Type
DRUG
Aromatase Inhibitors (Aromasin)
Comparison of efficacy with chemotherapy
Intervention Type
DRUG
Other Intervention Names
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Anastrozole
Nolvadex
Soltamox
Salpingo-oophorectomy Bilateral
Fluorouracil, Adriamycin, Cytoxan
Letrozole
Exemestane
Eligibility Criteria
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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
* 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
* pregnant
* disagree to enter the study
* had been given hormonal therapy or chemotherapy before study
* had contra-indication of SOB for pre-menopausal patients
Eligible Sex
FEMALE
Accepts Healthy Volunteers
Yes
Sponsors
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Dharmais National Cancer Center Hospital
OTHER_GOV
Sponsor Role
lead
Responsible Party
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Responsibility Role
SPONSOR
Principal Investigators
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Ramadhan Karsono, Doctoral
Role: STUDY_CHAIR
Dharmais National Cancer Center Hospital
Locations
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Dharmais National Cancer Center Hospital
Jakarta, , Indonesia
Site Status
Countries
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Indonesia
References
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Beatson GT. On the Treatment of Inoperable Cases of Carcinoma of the Mamma: Suggestions for a New Method of Treatment, with Illustrative Cases. Trans Med Chir Soc Edinb. 1896;15:153-179. No abstract available.
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Chuang E, Paul C, Flam A, McCarville K, Forst M, Shin S, Vahdat L, Swistel A, Simmons R, Osborne M. Breast cancer subtypes in Asian-Americans differ according to Asian ethnic group. J Immigr Minor Health. 2012 Oct;14(5):754-8. doi: 10.1007/s10903-012-9577-7.
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Hammond ME, Hayes DF, Dowsett M, Allred DC, Hagerty KL, Badve S, Fitzgibbons PL, Francis G, Goldstein NS, Hayes M, Hicks DG, Lester S, Love R, Mangu PB, McShane L, Miller K, Osborne CK, Paik S, Perlmutter J, Rhodes A, Sasano H, Schwartz JN, Sweep FC, Taube S, Torlakovic EE, Valenstein P, Viale G, Visscher D, Wheeler T, Williams RB, Wittliff JL, Wolff AC; American Society of Clinical Oncology; College of American Pathologists. American Society of Clinical Oncology/College of American Pathologists guideline recommendations for immunohistochemical testing of estrogen and progesterone receptors in breast cancer (unabridged version). Arch Pathol Lab Med. 2010 Jul;134(7):e48-72. doi: 10.5858/134.7.e48.
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von Minckwitz G, Blohmer JU, Costa SD, Denkert C, Eidtmann H, Eiermann W, Gerber B, Hanusch C, Hilfrich J, Huober J, Jackisch C, Kaufmann M, Kummel S, Paepke S, Schneeweiss A, Untch M, Zahm DM, Mehta K, Loibl S. Response-guided neoadjuvant chemotherapy for breast cancer. J Clin Oncol. 2013 Oct 10;31(29):3623-30. doi: 10.1200/JCO.2012.45.0940. Epub 2013 Sep 3.
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Reference Type
RESULT
Other Identifiers
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049/PEP/08/2011
Identifier Type: -
Identifier Source: org_study_id
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