Clinical trial · Interventional
Neoadjuvant Hormonal Therapy Compared to Neoadjuvant Chemotherapy in Stage IIIB/C and IV Breast Cancer Patients
Preoperative Neoadjuvant Hormonal Therapy and Neoadjuvant Chemotherapy for Stage IIIB and IV Breast Cancer Patients in Dharmais National Cancer Center Hospital, Indonesia
NCT02995772CI-TRIAL-00039126completedPhase 3ClinicalTrials.gov clinicaltrialsProvenance
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Breast Cancer | Malignant Breast Neoplasm | CURATED_EXACT | 0.92 |
Interventions
Interventions (6)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Aromatase Inhibitors (Arimidex) | Drug | — | UNRESOLVED |
| Aromatase Inhibitors (Aromasin) | Drug | — | UNRESOLVED |
| Aromatase Inhibitors (Femara) | Drug | — | UNRESOLVED |
| FAC | Drug | FAC Regimen | ALIAS |
| SOB | Procedure | — | UNRESOLVED |
| Tamoxifen | Drug | Tamoxifen | ALIAS |
Design
Arms and outcomes
Arms (2)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant hormonal therapy
- description
- Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen
- interventionNames
- Drug: Aromatase Inhibitors (Arimidex)
- Drug: Tamoxifen
- Procedure: SOB
- Drug: Aromatase Inhibitors (Femara)
- Drug: Aromatase Inhibitors (Aromasin)
- type
- ACTIVE_COMPARATOR
- label
- Neoadjuvant chemotherapy
- description
- Neoadjuvant chemotherapy: FAC 6 cycles
- interventionNames
- Drug: FAC
Primary outcomes (1)
- measure
Eligibility
Eligibility (as posted)
- Sex
- Female
Show eligibility criteria text
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
References
Publications (24)
- RESULTBeatson 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. PMID 29584099
- RESULTvan de Vijver MJ, He YD, van't Veer LJ, Dai H, Hart AA, Voskuil DW, Schreiber GJ, Peterse JL, Roberts C, Marton MJ, Parrish M, Atsma D, Witteveen A, Glas A, Delahaye L, van der Velde T, Bartelink H, Rodenhuis S, Rutgers ET, Friend SH, Bernards R. A gene-expression signature as a predictor of survival in breast cancer. N Engl J Med. 2002 Dec 19;347(25):1999-2009. doi: 10.1056/NEJMoa021967. PMID 12490681
- RESULTEarly Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of chemotherapy and hormonal therapy for early breast cancer on recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 May 14-20;365(9472):1687-717. doi: 10.1016/S0140-6736(05)66544-0. PMID 15894097
- RESULTCardoso F, van't Veer LJ, Bogaerts J, Slaets L, Viale G, Delaloge S, Pierga JY, Brain E, Causeret S, DeLorenzi M, Glas AM, Golfinopoulos V, Goulioti T, Knox S, Matos E, Meulemans B, Neijenhuis PA, Nitz U, Passalacqua R, Ravdin P, Rubio IT, Saghatchian M, Smilde TJ, Sotiriou C, Stork L, Straehle C, Thomas G, Thompson AM, van der Hoeven JM, Vuylsteke P, Bernards R, Tryfonidis K, Rutgers E, Piccart M; MINDACT Investigators. 70-Gene Signature as an Aid to Treatment Decisions in Early-Stage Breast Cancer. N Engl J Med. 2016 Aug 25;375(8):717-29. doi: 10.1056/NEJMoa1602253. PMID 27557300
- RESULTAsad J, Jacobson AF, Estabrook A, Smith SR, Boolbol SK, Feldman SM, Osborne MP, Boachie-Adjei K, Twardzik W, Tartter PI. Does oncotype DX recurrence score affect the management of patients with early-stage breast cancer? Am J Surg. 2008 Oct;196(4):527-9. doi: 10.1016/j.amjsurg.2008.06.021. PMID 18809056
- RESULTTeshome M, Hunt KK. Neoadjuvant therapy in the treatment of breast cancer. Surg Oncol Clin N Am. 2014 Jul;23(3):505-23. doi: 10.1016/j.soc.2014.03.006. Epub 2014 Apr 24.