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| ID | Type | Description | Link |
|---|---|---|---|
| ABCSG 28 | Other Identifier | ABCSG |
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| Name | Class |
|---|---|
| Bayer | INDUSTRY |
| Amgen | INDUSTRY |
| Hoffmann-La Roche | INDUSTRY |
| AstraZeneca |
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Primary Operation in synchronous metastasized invasive breast cancer to evaluate the use of local therapy
This study is a prospective, randomized, multicentre, study concerning the influence of local treatment on the patients with synchronous metastasized breast cancer. Patients will be stratified at inclusion according to the centre, the menopausal status (pre-menopausal, post-menopausal), the hormone-receptor status (ER-/PR-/not determinable; any PR and/or Er+), the HER-2 status (positive vs. negative/not determinable), the grading (G1/G2/not determinable vs. G3), location of metastases (visceral ± vs bone only), organs with metastases (single organ vs multiple organs) and use of first line chemotherapy (anthracycline ± vs. taxane vs others). Thereafter patients will be randomly assigned to receive either local therapy of the breast (lumpectomy or mastectomy + axillary surgery /± radiotherapy) versus no local therapy. Systemic therapy will be administered at the centers policy.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| A: Surgical Therapy | Other | Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory). |
|
| B: Surgery on Demand | Other | In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Surgery | Procedure | lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II) |
|
| Measure | Description | Time Frame |
|---|---|---|
| Overall Survival (OS) | Overall Survival with vs without local therapy (surgery) | Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months |
| Measure | Description | Time Frame |
|---|---|---|
| Time to Distant Progression | Time to distant progression with vs without local therapy (surgery) | Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months |
| Time to Local Progression (TTPl) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Florian Fitzal, MD | Austrian Breast & Colorectal Cancer Study Group | Study Director |
| Michael Gnant, MD | Austrian Breast & Colorectal Cancer Study Group | Study Director |
| Guenther Steger, MD | Austrian Breast & Colorectal Cancer Study Group | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Guessing | Guessing | Burgenland | 7540 | Austria | ||
| Hospital Oberpullendorf |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 16614878 | Background | Babiera GV, Rao R, Feng L, Meric-Bernstam F, Kuerer HM, Singletary SE, Hunt KK, Ross MI, Gwyn KM, Feig BW, Ames FC, Hortobagyi GN. Effect of primary tumor extirpation in breast cancer patients who present with stage IV disease and an intact primary tumor. Ann Surg Oncol. 2006 Jun;13(6):776-82. doi: 10.1245/ASO.2006.03.033. Epub 2006 Apr 17. | |
| Background | Blanchard DK, Bhatia P, Hilsenbeck SG, Elledge RM. Does surgical management of stage IV breast cancer effect outcome? SABCC 2006, San Antonio | ||
| 12559070 |
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The first patient was randomized November 24, 2010, the last patient was randomized October 30, 2015. Randomization took place in 14 Austrian clinical sites. In total, 90 patients were enrolled.
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| ID | Title | Description |
|---|---|---|
| FG000 | A: Surgical Therapy | Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory). Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II) |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
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| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | Feb 10, 2012 | Aug 16, 2023 |
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| Sanofi | INDUSTRY |
| Wyeth-Lederle Pharma GmbH | INDUSTRY |
| GlaxoSmithKline | INDUSTRY |
| Merck Sharp & Dohme LLC | INDUSTRY |
| Fond of the Viennese Mayor | OTHER |
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| Surgery on Demand | Procedure | if necessary local therapy on demand |
|
Time to local progression with vs without local therapy (surgery)
| Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months |
| Oberpullendorf |
| Burgenland |
| 7350 |
| Austria |
| Ordination Dr. Wette | Saint Veit A. D. Glan | Carinthia | 9300 | Austria |
| Gynaegological Medical University Graz | Graz | Styria | 8036 | Austria |
| Medical University Graz, Oncology | Graz | Styria | 8036 | Austria |
| Medical University of Innsbruck | Innsbruck | Tyrol | 6020 | Austria |
| Ordensklinikum Linz GmbH - BHS Linz, Coop. Study Group | Linz | Upper Austria | 4010 | Austria |
| Ordensklinikum Linz GmbH - Elisabethinen Linz | Linz | Upper Austria | 4010 | Austria |
| General Hospital Linz | Linz | Upper Austria | 4020 | Austria |
| Klinikum Wels-Grieskirchen GmbH | Wels | Upper Austria | 4600 | Austria |
| State Hospital Feldkirch | Feldkirch | Vorarlberg | 6807 | Austria |
| Paracelsus Medical University Salzburg-Oncology, Coop. Group | Salzburg | 5020 | Austria |
| Medical University of Vienna-General Hospital Vienna | Vienna | 1090 | Austria |
| Medical University of Vienna | Vienna | 1090 | Austria |
| Background |
| Carmichael AR, Anderson ED, Chetty U, Dixon JM. Does local surgery have a role in the management of stage IV breast cancer? Eur J Surg Oncol. 2003 Feb;29(1):17-9. doi: 10.1053/ejso.2002.1339. |
| 12407345 | Background | Khan SA, Stewart AK, Morrow M. Does aggressive local therapy improve survival in metastatic breast cancer? Surgery. 2002 Oct;132(4):620-6; discussion 626-7. doi: 10.1067/msy.2002.127544. |
| 16702580 | Background | Rapiti E, Verkooijen HM, Vlastos G, Fioretta G, Neyroud-Caspar I, Sappino AP, Chappuis PO, Bouchardy C. Complete excision of primary breast tumor improves survival of patients with metastatic breast cancer at diagnosis. J Clin Oncol. 2006 Jun 20;24(18):2743-9. doi: 10.1200/JCO.2005.04.2226. Epub 2006 May 15. |
| 17522944 | Background | Gnerlich J, Jeffe DB, Deshpande AD, Beers C, Zander C, Margenthaler JA. Surgical removal of the primary tumor increases overall survival in patients with metastatic breast cancer: analysis of the 1988-2003 SEER data. Ann Surg Oncol. 2007 Aug;14(8):2187-94. doi: 10.1245/s10434-007-9438-0. Epub 2007 May 24. |
| 12393820 | Background | Fisher B, Anderson S, Bryant J, Margolese RG, Deutsch M, Fisher ER, Jeong JH, Wolmark N. Twenty-year follow-up of a randomized trial comparing total mastectomy, lumpectomy, and lumpectomy plus irradiation for the treatment of invasive breast cancer. N Engl J Med. 2002 Oct 17;347(16):1233-41. doi: 10.1056/NEJMoa022152. |
| 12393819 | Background | Veronesi U, Cascinelli N, Mariani L, Greco M, Saccozzi R, Luini A, Aguilar M, Marubini E. Twenty-year follow-up of a randomized study comparing breast-conserving surgery with radical mastectomy for early breast cancer. N Engl J Med. 2002 Oct 17;347(16):1227-32. doi: 10.1056/NEJMoa020989. |
| 16360786 | Background | Clarke M, Collins R, Darby S, Davies C, Elphinstone P, Evans V, Godwin J, Gray R, Hicks C, James S, MacKinnon E, McGale P, McHugh T, Peto R, Taylor C, Wang Y; Early Breast Cancer Trialists' Collaborative Group (EBCTCG). Effects of radiotherapy and of differences in the extent of surgery for early breast cancer on local recurrence and 15-year survival: an overview of the randomised trials. Lancet. 2005 Dec 17;366(9503):2087-106. doi: 10.1016/S0140-6736(05)67887-7. |
| 11759643 | Background | Flanigan RC, Salmon SE, Blumenstein BA, Bearman SI, Roy V, McGrath PC, Caton JR Jr, Munshi N, Crawford ED. Nephrectomy followed by interferon alfa-2b compared with interferon alfa-2b alone for metastatic renal-cell cancer. N Engl J Med. 2001 Dec 6;345(23):1655-9. doi: 10.1056/NEJMoa003013. |
| 11583750 | Background | Mickisch GH, Garin A, van Poppel H, de Prijck L, Sylvester R; European Organisation for Research and Treatment of Cancer (EORTC) Genitourinary Group. Radical nephrectomy plus interferon-alfa-based immunotherapy compared with interferon alfa alone in metastatic renal-cell carcinoma: a randomised trial. Lancet. 2001 Sep 22;358(9286):966-70. doi: 10.1016/s0140-6736(01)06103-7. |
| 16892025 | Background | Norton L, Massague J. Is cancer a disease of self-seeding? Nat Med. 2006 Aug;12(8):875-8. doi: 10.1038/nm0806-875. No abstract available. |
| 15378087 | Background | Al-Hajj M, Clarke MF. Self-renewal and solid tumor stem cells. Oncogene. 2004 Sep 20;23(43):7274-82. doi: 10.1038/sj.onc.1207947. |
| 17051156 | Background | Bao S, Wu Q, McLendon RE, Hao Y, Shi Q, Hjelmeland AB, Dewhirst MW, Bigner DD, Rich JN. Glioma stem cells promote radioresistance by preferential activation of the DNA damage response. Nature. 2006 Dec 7;444(7120):756-60. doi: 10.1038/nature05236. Epub 2006 Oct 18. |
| 12629218 | Background | Al-Hajj M, Wicha MS, Benito-Hernandez A, Morrison SJ, Clarke MF. Prospective identification of tumorigenic breast cancer cells. Proc Natl Acad Sci U S A. 2003 Apr 1;100(7):3983-8. doi: 10.1073/pnas.0530291100. Epub 2003 Mar 10. |
| 7543740 | Background | Kong FM, Anscher MS, Murase T, Abbott BD, Iglehart JD, Jirtle RL. Elevated plasma transforming growth factor-beta 1 levels in breast cancer patients decrease after surgical removal of the tumor. Ann Surg. 1995 Aug;222(2):155-62. doi: 10.1097/00000658-199508000-00007. |
| 14523048 | Background | Tang B, Vu M, Booker T, Santner SJ, Miller FR, Anver MR, Wakefield LM. TGF-beta switches from tumor suppressor to prometastatic factor in a model of breast cancer progression. J Clin Invest. 2003 Oct;112(7):1116-24. doi: 10.1172/JCI18899. |
| 12070308 | Background | Yang YA, Dukhanina O, Tang B, Mamura M, Letterio JJ, MacGregor J, Patel SC, Khozin S, Liu ZY, Green J, Anver MR, Merlino G, Wakefield LM. Lifetime exposure to a soluble TGF-beta antagonist protects mice against metastasis without adverse side effects. J Clin Invest. 2002 Jun;109(12):1607-15. doi: 10.1172/JCI15333. |
| 7683111 | Background | Kim KJ, Li B, Winer J, Armanini M, Gillett N, Phillips HS, Ferrara N. Inhibition of vascular endothelial growth factor-induced angiogenesis suppresses tumour growth in vivo. Nature. 1993 Apr 29;362(6423):841-4. doi: 10.1038/362841a0. |
| 10735889 | Background | Linderholm B, Grankvist K, Wilking N, Johansson M, Tavelin B, Henriksson R. Correlation of vascular endothelial growth factor content with recurrences, survival, and first relapse site in primary node-positive breast carcinoma after adjuvant treatment. J Clin Oncol. 2000 Apr;18(7):1423-31. doi: 10.1200/JCO.2000.18.7.1423. |
| 14715109 | Background | Linderholm BK, Lindh B, Beckman L, Erlanson M, Edin K, Travelin B, Bergh J, Grankvist K, Henriksson R. Prognostic correlation of basic fibroblast growth factor and vascular endothelial growth factor in 1307 primary breast cancers. Clin Breast Cancer. 2003 Dec;4(5):340-7. doi: 10.3816/cbc.2003.n.039. |
| 12736564 | Background | Nishimura R, Nagao K, Miyayama H, Matsuda M, Baba K, Yamashita H, Fukuda M. Higher plasma vascular endothelial growth factor levels correlate with menopause, overexpression of p53, and recurrence of breast cancer. Breast Cancer. 2003;10(2):120-8. doi: 10.1007/BF02967636. |
| 11836562 | Background | Wu Y, Saldana L, Chillar R, Vadgama JV. Plasma vascular endothelial growth factor is useful in assessing progression of breast cancer post surgery and during adjuvant treatment. Int J Oncol. 2002 Mar;20(3):509-16. |
| 16617567 | Background | Kummel S, Eggemann H, Luftner D, Thomas A, Jeschke S, Zerfel N, Heilmann V, Emons G, Zeiser T, Ulm K, Kobl M, Korlach S, Schmid P, Sehouli J, Elling D, Blohmer JU. Changes in the circulating plasma levels of VEGF and VEGF-D after adjuvant chemotherapy in patients with breast cancer and 1 to 3 positive lymph nodes. Anticancer Res. 2006 Mar-Apr;26(2C):1719-26. |
| 16891056 | Background | Caine GJ, Stonelake PS, Lip GY, Blann AD. Changes in plasma vascular endothelial growth factor, angiopoietins, and their receptors following surgery for breast cancer. Cancer Lett. 2007 Apr 8;248(1):131-6. doi: 10.1016/j.canlet.2006.06.011. Epub 2006 Aug 7. |
| 16184456 | Background | Curigliano G, Petit JY, Bertolini F, Colleoni M, Peruzzotti G, de Braud F, Gandini S, Giraldo A, Martella S, Orlando L, Munzone E, Pietri E, Luini A, Goldhirsch A. Systemic effects of surgery: quantitative analysis of circulating basic fibroblast growth factor (bFGF), Vascular endothelial growth factor (VEGF) and transforming growth factor beta (TGF-beta) in patients with breast cancer who underwent limited or extended surgery. Breast Cancer Res Treat. 2005 Sep;93(1):35-40. doi: 10.1007/s10549-005-3381-1. |
| 8689103 | Background | Joffe JK, Banks RE, Forbes MA, Hallam S, Jenkins A, Patel PM, Hall GD, Velikova G, Adams J, Crossley A, Johnson PW, Whicher JT, Selby PJ. A phase II study of interferon-alpha, interleukin-2 and 5-fluorouracil in advanced renal carcinoma: clinical data and laboratory evidence of protease activation. Br J Urol. 1996 May;77(5):638-49. doi: 10.1046/j.1464-410x.1996.09573.x. |
| 10379736 | Background | Wagner JR, Walther MM, Linehan WM, White DE, Rosenberg SA, Yang JC. Interleukin-2 based immunotherapy for metastatic renal cell carcinoma with the kidney in place. J Urol. 1999 Jul;162(1):43-5. doi: 10.1097/00005392-199907000-00011. |
| 16502019 | Background | Fitzal F, Sporn EP, Draxler W, Mittlbock M, Taucher S, Rudas M, Riedl O, Helbich TH, Jakesz R, Gnant M. Preoperative core needle biopsy does not increase local recurrence rate in breast cancer patients. Breast Cancer Res Treat. 2006 May;97(1):9-15. doi: 10.1007/s10549-005-6935-3. |
| 17457156 | Background | El-Tamer MB, Ward BM, Schifftner T, Neumayer L, Khuri S, Henderson W. Morbidity and mortality following breast cancer surgery in women: national benchmarks for standards of care. Ann Surg. 2007 May;245(5):665-71. doi: 10.1097/01.sla.0000245833.48399.9a. |
| 32375735 | Derived | Bjelic-Radisic V, Fitzal F, Knauer M, Steger G, Egle D, Greil R, Schrenk P, Balic M, Singer C, Exner R, Soelkner L, Gnant M; ABCSG. Primary surgery versus no surgery in synchronous metastatic breast cancer: patient-reported quality-of-life outcomes of the prospective randomized multicenter ABCSG-28 Posytive Trial. BMC Cancer. 2020 May 6;20(1):392. doi: 10.1186/s12885-020-06894-2. |
| FG001 | B: Surgery on Demand | In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat. Surgery on Demand: if necessary local therapy on demand |
| COMPLETED |
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| NOT COMPLETED |
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Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | A: Surgical Therapy | Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory). Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II) |
| BG001 | B: Surgery on Demand | In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat. Surgery on Demand: if necessary local therapy on demand |
| BG002 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | ||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Median | Full Range | years |
| |||||||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| ||||||||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| |||||||||||||||
| T-stage | The clincial T-stage (cT) describes the categories of tumor size: cT1: <2 cm, cT2: 2 to 5 cm, cT3: > 5 cm, cT4: tumor has invaded other organs, like chest wall or skin. | Count of Participants | Participants |
| |||||||||||||||
| N-stage | The clinical N-stage describes the categories of affected lymph nodes: cN0: no lymph node affected, cN1: 1-3 lymph nodes affected, cN2: 4 to 9 lymph nodes affected, cN3: 10 or more lymph nodes affected. | Count of Participants | Participants |
| |||||||||||||||
| Histologic grade | The histologic grade describes to which extent the cancer cells and their arrangement look look like normal cells. Grade 1 (G1): well-differentiated, cells look more like normal breast tissue; Grade (G2): moderately differentiated; Grade (G3): poorly differentiated; GX: grade cannot be assessed. | Count of Participants | Participants |
| |||||||||||||||
| Hormone receptor group | Count of Participants | Participants |
| ||||||||||||||||
| HER2 group | Count of Participants | Participants |
| ||||||||||||||||
| Surgery type | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Overall Survival (OS) | Overall Survival with vs without local therapy (surgery) | Intent-to-treat population: All participants assigned to one of the two treatment arms were included in the analysis | Posted | Median | 95% Confidence Interval | months | Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months |
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| Secondary | Time to Distant Progression | Time to distant progression with vs without local therapy (surgery) | Intent-to-treat population: All participants assigned to one of the two treatment arms were included in the analysis | Posted | Median | 95% Confidence Interval | months | Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months |
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| Secondary | Time to Local Progression (TTPl) | Time to local progression with vs without local therapy (surgery) | Intent-to-treat population: All participants assigned to one of the two treatment arms were included in the analysis | Posted | Median | 95% Confidence Interval | months | Time from randomization until the last visit of the last participant; maximum time on study was 63.9 months |
|
Maximum observation period per patient for all-cause mortality was 10 years starting with randomization.
All-cause mortality data presented for intention-to-treat analysis set and for the entire study. Serious adverse events and other (non-serious) adverse events were not assessed for the study.
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | A: Surgical Therapy | Local therapy consists of lumpectomy or mastectomy with or without radiotherapy (according to center tumor board decision) with a resection free margin of at least 1 mm or more demonstrated on paraffin embedded histological sections. Intraoperative frozen sections are allowed but not definitive for margin assessment. Sentinel node biopsy may be performed and has always to be followed by axillary dissection of level I and II (axillary surgery level I and II is mandatory). Surgery: lumpectomy or mastectomy with or without radiotherapy. Sentinel biopsy followed by axillary dissection (level I-II) | 30 | 45 | 0 | 0 | 0 | 0 |
| EG001 | B: Surgery on Demand | In Arm B (no local therapy) it may be necessary to perform local therapy on demand (surgery, radiotherapy). Reasons may be uncontrolled bleeding or infected exulcerations with a septic component and no treatment benefit from conservative therapy. This will be considered as protocol deviation. However, the patient's follow up is recorded and data are available for analyses as intention to treat. Surgery on Demand: if necessary local therapy on demand | 22 | 45 | 0 | 0 | 0 | 0 |
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Trial Office Director | ABCSG (Austrian Breast & Colorectal Cancer Study Group) | +43 1 4089230 | info@abcsg.at |
| Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | Jan 11, 2017 | Aug 16, 2023 | SAP_001.pdf |
| ID | Term |
|---|---|
| D009360 | Neoplastic Cells, Circulating |
| D001943 | Breast Neoplasms |
| ID | Term |
|---|---|
| D009362 | Neoplasm Metastasis |
| D009385 | Neoplastic Processes |
| D009369 | Neoplasms |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |
Not provided
Not provided
| ID | Term |
|---|---|
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
Not provided
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| Superiority |
A two-sided significance level of 5% was used. |
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