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The NAPOLI Study is a retrospective multicenter observational study designed to characterize negative hormone receptor and apocrine lobular invasive breast cancer. The study will collect real-world clinicopathological, molecular, therapeutic and outcome data from patients diagnosed and treated at participating centers. The aim is to describe the clinical behavior, pathological features, receptor profile, treatments received and oncologic outcomes of this rare breast cancer subtype.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Upfront Breast Surgery | Procedure | Upfront Conservative or Demolitive Breast Surgery | ||
| Adjuvant Radiotherapy | Radiation | Adjuvant Breast or Chest Wall Radiotherapy after Breast Surgery | ||
| Endocrine Therapy | Drug | Adjuvant or Neoadjuvant Endocrine Therapy | ||
| Chemotherapy | Drug | Adjuvant or Neoadjuvant Chemotherapy |
| Measure | Description | Time Frame |
|---|---|---|
| Clinicopathological characterization of apocrine invasive lobular breast carcinoma | Measured by descriptive analysis of tumor size, grade, nodal status, ER, PgR, HER2, Ki-67, androgen receptor, stage, histological features and treatment received. | Through study completion, an average of 5 years |
| Measure | Description | Time Frame |
|---|---|---|
| Disease-Free Survival | Through study completion, an average of 5 years | |
| Overall Survival | Through study completion, an average of 5 years | |
| Recurrence Rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients diagnosed between January 1, 2010 and December 31, 2025 will be included. Follow-up will be collected until the most recent available clinical update.
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Massimo Ferrucci, MD PhD | Contact | 049 821 5500 | massimoferrucci@gmail.com | |
| Daniele Passeri, MD | Contact | +39 333 383 9397 | daniele.passeri.1995@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Francesco Milardi, MD | Veneto Institute of Oncology IRCCS | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Veneto Institute of Oncology | Recruiting | Padova | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39748709 | Background | Cserni G. Invasive lobular carcinoma of the breast: we diagnose it, but do we know what it is? Pathologica. 2024 Oct;116(5):273-284. doi: 10.32074/1591-951X-1043. | |
| 32795829 | Background | Montagna E, Cancello G, Pagan E, Bagnardi V, Munzone E, Dellapasqua S, Viale G, Mazzarol G, Veronesi P, Galimberti V, Santomauro G, Colleoni M. Prognosis of selected triple negative apocrine breast cancer patients who did not receive adjuvant chemotherapy. Breast. 2020 Oct;53:138-142. doi: 10.1016/j.breast.2020.07.003. Epub 2020 Jul 24. |
| Label | URL |
|---|---|
| Related Info | View source |
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| ID | Term |
|---|---|
| D018275 | Carcinoma, Lobular |
| D009369 | Neoplasms |
| ID | Term |
|---|---|
| D000230 | Adenocarcinoma |
| D002277 | Carcinoma |
| D009375 | Neoplasms, Glandular and Epithelial |
| D009370 | Neoplasms by Histologic Type |
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| ID | Term |
|---|---|
| D018714 | Radiotherapy, Adjuvant |
| D004358 | Drug Therapy |
| ID | Term |
|---|---|
| D003131 | Combined Modality Therapy |
| D013812 | Therapeutics |
| D011878 | Radiotherapy |
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Measured as local, regional or distant recurrence. |
| Through study completion, an average of 5 years |
| 27259012 | Background | Mills AM, E Gottlieb C, M Wendroth S, M Brenin C, Atkins KA. Pure Apocrine Carcinomas Represent a Clinicopathologically Distinct Androgen Receptor-Positive Subset of Triple-Negative Breast Cancers. Am J Surg Pathol. 2016 Aug;40(8):1109-16. doi: 10.1097/PAS.0000000000000671. |
| 36972361 | Background | Dai C, Ellisen LW. Revisiting Androgen Receptor Signaling in Breast Cancer. Oncologist. 2023 May 8;28(5):383-391. doi: 10.1093/oncolo/oyad049. |
| 19898421 | Background | Niemeier LA, Dabbs DJ, Beriwal S, Striebel JM, Bhargava R. Androgen receptor in breast cancer: expression in estrogen receptor-positive tumors and in estrogen receptor-negative tumors with apocrine differentiation. Mod Pathol. 2010 Feb;23(2):205-12. doi: 10.1038/modpathol.2009.159. Epub 2009 Nov 6. |
| 21552212 | Background | Collins LC, Cole KS, Marotti JD, Hu R, Schnitt SJ, Tamimi RM. Androgen receptor expression in breast cancer in relation to molecular phenotype: results from the Nurses' Health Study. Mod Pathol. 2011 Jul;24(7):924-31. doi: 10.1038/modpathol.2011.54. Epub 2011 May 6. |
| 30811750 | Background | Ishii A, Oishi T, Kakuda Y, Yasui H, Kawata T, Muramatsu K, Takahashi K, Sugino T. Mixed pleomorphic lobular and apocrine carcinoma of the breast: A case report suggesting pathogenesis. Pathol Int. 2019 May;69(5):288-293. doi: 10.1111/pin.12781. Epub 2019 Feb 27. |
| 12172583 | Background | Kaya H, Aribal E, Yegen C. Apocrine differentiation in invasive pleomorphic lobular carcinoma with in situ ductal and lobular apocrine carcinoma: case report. Pathol Oncol Res. 2002;8(2):151-2. doi: 10.1007/BF03033728. |
| Background | Eusebi V, Millis RR, Cattani MG, et al. Apocrine differentiation in lobular carcinoma of the breast. Virchows Arch A Pathol Anat Histopathol. 1984. |
| Background | Yang C, Wang I, Yen Y. Apocrine carcinoma of the breast: Review. Forum Clin Oncol. 2023. |
| 23663520 | Background | Lehmann-Che J, Hamy AS, Porcher R, Barritault M, Bouhidel F, Habuellelah H, Leman-Detours S, de Roquancourt A, Cahen-Doidy L, Bourstyn E, de Cremoux P, de Bazelaire C, Albiter M, Giacchetti S, Cuvier C, Janin A, Espie M, de The H, Bertheau P. Molecular apocrine breast cancers are aggressive estrogen receptor negative tumors overexpressing either HER2 or GCDFP15. Breast Cancer Res. 2013 May 11;15(3):R37. doi: 10.1186/bcr3421. |
| 28027454 | Background | Vranic S, Feldman R, Gatalica Z. Apocrine carcinoma of the breast: A brief update on the molecular features and targetable biomarkers. Bosn J Basic Med Sci. 2017 Feb 21;17(1):9-11. doi: 10.17305/bjbms.2016.1811. |
| D018299 | Neoplasms, Ductal, Lobular, and Medullary |
| D001943 | Breast Neoplasms |
| D009371 | Neoplasms by Site |
| D001941 | Breast Diseases |
| D012871 | Skin Diseases |
| D017437 | Skin and Connective Tissue Diseases |