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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)
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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Neoadjuvant hormonal therapy | Active Comparator | Neoadjuvant hormonal therapy: Aromatase inhibitors (Arimidex, Femara, Aromasin), Tamoxifen, SOB and AI, SOB and Tamoxifen |
|
| Neoadjuvant chemotherapy | Active Comparator | Neoadjuvant chemotherapy: FAC 6 cycles |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Aromatase Inhibitors (Arimidex) | Drug | Comparison of efficacy with chemotherapy |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Progressive free survival | length of time from after treatment until tumor progression or death from any cause | time from after treatment until tumor progression or death from any cause and until minimum sample sizes are met and an average 3 years |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ramadhan Karsono, Doctoral | Dharmais National Cancer Center Hospital | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dharmais National Cancer Center Hospital | Jakarta | 11420 | Indonesia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 29584099 | Result | 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. | |
| 12490681 | Result | van 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. |
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We have not decided on this yet
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| Tamoxifen | Drug | Comparison of efficacy with chemotherapy |
|
|
| SOB | Procedure | Comparison of efficacy with chemotherapy |
|
|
| FAC | Drug | Comparison of efficacy with hormonal therapy |
|
|
| Aromatase Inhibitors (Femara) | Drug | Comparison of efficacy with chemotherapy |
|
|
| Aromatase Inhibitors (Aromasin) | Drug | Comparison of efficacy with chemotherapy |
|
|
| 15894097 | Result | Early 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. |
| 27557300 | Result | Cardoso 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. |
| 18809056 | Result | Asad 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. |
| 24882348 | Result | Teshome 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. |
| 10076721 | Result | Mauriac L, MacGrogan G, Avril A, Durand M, Floquet A, Debled M, Dilhuydy JM, Bonichon F. Neoadjuvant chemotherapy for operable breast carcinoma larger than 3 cm: a unicentre randomized trial with a 124-month median follow-up. Institut Bergonie Bordeaux Groupe Sein (IBBGS). Ann Oncol. 1999 Jan;10(1):47-52. doi: 10.1023/a:1008337009350. |
| 20700118 | Result | Chia YH, Ellis MJ, Ma CX. Neoadjuvant endocrine therapy in primary breast cancer: indications and use as a research tool. Br J Cancer. 2010 Sep 7;103(6):759-64. doi: 10.1038/sj.bjc.6605845. Epub 2010 Aug 10. |
| 26019189 | Result | Bossuyt V, Provenzano E, Symmans WF, Boughey JC, Coles C, Curigliano G, Dixon JM, Esserman LJ, Fastner G, Kuehn T, Peintinger F, von Minckwitz G, White J, Yang W, Badve S, Denkert C, MacGrogan G, Penault-Llorca F, Viale G, Cameron D; Breast International Group-North American Breast Cancer Group (BIG-NABCG) collaboration. Recommendations for standardized pathological characterization of residual disease for neoadjuvant clinical trials of breast cancer by the BIG-NABCG collaboration. Ann Oncol. 2015 Jul;26(7):1280-91. doi: 10.1093/annonc/mdv161. Epub 2015 May 27. |
| 22286607 | Result | 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. |
| 20586616 | Result | 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. |
| 24409418 | Result | Marcus DM, Switchenko JM, Prabhu R, O'Regan R, Zelnak A, Fasola C, Mister D, Torres MA. Neoadjuvant Hormonal Therapy is Associated with Comparable Outcomes to Neoadjuvant Chemotherapy in Post-Menopausal Women with Estrogen Receptor-Positive Breast Cancer. Front Oncol. 2013 Dec 27;3:317. doi: 10.3389/fonc.2013.00317. eCollection 2013. |
| 17538978 | Result | Semiglazov VF, Semiglazov VV, Dashyan GA, Ziltsova EK, Ivanov VG, Bozhok AA, Melnikova OA, Paltuev RM, Kletzel A, Berstein LM. Phase 2 randomized trial of primary endocrine therapy versus chemotherapy in postmenopausal patients with estrogen receptor-positive breast cancer. Cancer. 2007 Jul 15;110(2):244-54. doi: 10.1002/cncr.22789. |
| 6802332 | Result | Preece PE, Wood RA, Mackie CR, Cuschieri A. Tamoxifen as initial sole treatment of localised breast cancer in elderly women: a pilot study. Br Med J (Clin Res Ed). 1982 Mar 20;284(6319):869-70. doi: 10.1136/bmj.284.6319.869-a. No abstract available. |
| 18258986 | Result | Rastogi P, Anderson SJ, Bear HD, Geyer CE, Kahlenberg MS, Robidoux A, Margolese RG, Hoehn JL, Vogel VG, Dakhil SR, Tamkus D, King KM, Pajon ER, Wright MJ, Robert J, Paik S, Mamounas EP, Wolmark N. Preoperative chemotherapy: updates of National Surgical Adjuvant Breast and Bowel Project Protocols B-18 and B-27. J Clin Oncol. 2008 Feb 10;26(5):778-85. doi: 10.1200/JCO.2007.15.0235. |
| 23704196 | Result | Schneeweiss A, Chia S, Hickish T, Harvey V, Eniu A, Hegg R, Tausch C, Seo JH, Tsai YF, Ratnayake J, McNally V, Ross G, Cortes J. Pertuzumab plus trastuzumab in combination with standard neoadjuvant anthracycline-containing and anthracycline-free chemotherapy regimens in patients with HER2-positive early breast cancer: a randomized phase II cardiac safety study (TRYPHAENA). Ann Oncol. 2013 Sep;24(9):2278-84. doi: 10.1093/annonc/mdt182. Epub 2013 May 22. |
| 26657653 | Result | Hamy AS, Belin L, Bonsang-Kitzis H, Paquet C, Pierga JY, Lerebours F, Cottu P, Rouzier R, Savignoni A, Lae M, Reyal F. Pathological complete response and prognosis after neoadjuvant chemotherapy for HER2-positive breast cancers before and after trastuzumab era: results from a real-life cohort. Br J Cancer. 2016 Jan 12;114(1):44-52. doi: 10.1038/bjc.2015.426. Epub 2015 Dec 10. |
| 2260873 | Result | Tashiro H, Nomura Y, Hisamatsu K. [A randomized trial of endocrine therapy, chemotherapy, and chemo-endocrine therapy in advanced breast cancer]. Gan To Kagaku Ryoho. 1990 Dec;17(12):2369-73. Japanese. |
| 24002511 | Result | 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. |
| 8520164 | Result | Abe O, Asaishi K, Izuo M, Enomoto K, Koyama H, Tominaga T, Nomura Y, Ohshima A, Aoki N, Tsukada T. Effects of medroxyprogesterone acetate therapy on advanced or recurrent breast cancer and its influences on blood coagulation and the fibrinolytic system. Surg Today. 1995;25(8):701-10. doi: 10.1007/BF00311486. |
| 20194852 | Result | Saad ED, Katz A, Buyse M. Overall survival and post-progression survival in advanced breast cancer: a review of recent randomized clinical trials. J Clin Oncol. 2010 Apr 10;28(11):1958-62. doi: 10.1200/JCO.2009.25.5414. Epub 2010 Mar 1. |
| 12804433 | Result | Wilcken N, Hornbuckle J, Ghersi D. Chemotherapy alone versus endocrine therapy alone for metastatic breast cancer. Cochrane Database Syst Rev. 2003;2003(2):CD002747. doi: 10.1002/14651858.CD002747. |
| 3139179 | Result | Robertson JF, Todd JH, Ellis IO, Elston CW, Blamey RW. Comparison of mastectomy with tamoxifen for treating elderly patients with operable breast cancer. BMJ. 1988 Aug 20-27;297(6647):511-4. doi: 10.1136/bmj.297.6647.511. |
| 26363985 | Result | Badwe R, Hawaldar R, Nair N, Kaushik R, Parmar V, Siddique S, Budrukkar A, Mittra I, Gupta S. Locoregional treatment versus no treatment of the primary tumour in metastatic breast cancer: an open-label randomised controlled trial. Lancet Oncol. 2015 Oct;16(13):1380-8. doi: 10.1016/S1470-2045(15)00135-7. Epub 2015 Sep 9. |
| ID | Term |
|---|---|
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009371 | Neoplasms by Site |
| D009369 | Neoplasms |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
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| ID | Term |
|---|---|
| D047072 | Aromatase Inhibitors |
| D000077384 | Anastrozole |
| D013629 | Tamoxifen |
| D005472 | Fluorouracil |
| D004317 | Doxorubicin |
| D003520 | Cyclophosphamide |
| D000077289 | Letrozole |
| C056516 | exemestane |
| ID | Term |
|---|---|
| D065088 | Steroid Synthesis Inhibitors |
| D004791 | Enzyme Inhibitors |
| D045504 | Molecular Mechanisms of Pharmacological Action |
| D020228 | Pharmacologic Actions |
| D020164 | Chemical Actions and Uses |
| D004965 | Estrogen Antagonists |
| D006727 | Hormone Antagonists |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D045505 | Physiological Effects of Drugs |
| D009570 | Nitriles |
| D009930 | Organic Chemicals |
| D014230 | Triazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D013267 | Stilbenes |
| D001597 | Benzylidene Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D014498 | Uracil |
| D011744 | Pyrimidinones |
| D011743 | Pyrimidines |
| D003630 | Daunorubicin |
| D018943 | Anthracyclines |
| D009279 | Naphthacenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
| D011083 | Polycyclic Compounds |
| D000617 | Aminoglycosides |
| D006027 | Glycosides |
| D002241 | Carbohydrates |
| D010752 | Phosphoramide Mustards |
| D009588 | Nitrogen Mustard Compounds |
| D009150 | Mustard Compounds |
| D006846 | Hydrocarbons, Halogenated |
| D063088 | Phosphoramides |
| D009943 | Organophosphorus Compounds |
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