Negative Hormone Receptor and APOcrine Lobular Invasive Breast Cancer

NCT07613151 | Recruiting

• 1 other identifier: CESC IOV 2023-61
• Study Type: observational
• Target: 250
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Lobular Breast Carcinoma

Keywords

Breast; Cancer; Lobular Neoplasia

Outcome Measures

Primary Outcomes (1)

• 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

Secondary Outcomes (3)

• Disease-Free Survival

  Through study completion, an average of 5 years

• Overall Survival

  Through study completion, an average of 5 years

• Recurrence Rate

  Through study completion, an average of 5 years

Interventions

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

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

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.

You may qualify if:

• Female or male patients aged ≥18 years.
• Histologically confirmed invasive lobular carcinoma of the breast.
• Presence of apocrine differentiation/features documented in pathology report or confirmed by local pathology review.
• Negative hormone receptors.
• Diagnosis and/or treatment at one of the participating centers.
• Availability of essential clinicopathological data.
• Availability of follow-up data, when applicable.

You may not qualify if:

• Pure ductal carcinoma without lobular invasive component.
• Metastatic tumor to the breast from non-breast primary cancer.
• Insufficient pathological documentation to confirm eligibility.
• Missing essential clinical data.
• Patients who denied consent for retrospective data use, where applicable by local regulations.

Sponsors & Collaborators

• Istituto Oncologico Veneto IRCCS: lead

Study Sites (1)

Veneto Institute of Oncology

Padova, Italy

RECRUITING

Related Publications (12)

• 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.

  PMID: 39748709 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.

  PMID: 32795829 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.

  PMID: 27259012 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.

  PMID: 36972361 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.

  PMID: 19898421 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.

  PMID: 21552212 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.

  PMID: 30811750 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.

  PMID: 12172583 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.

  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.

  PMID: 23663520 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.

  PMID: 28027454 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Carcinoma, Lobular; Neoplasms

Interventions

Radiotherapy, Adjuvant; Drug Therapy

Condition Hierarchy (Ancestors)

Adenocarcinoma; Carcinoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms, Ductal, Lobular, and Medullary; Breast Neoplasms; Neoplasms by Site; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Combined Modality Therapy; Therapeutics; Radiotherapy

Study Officials

• Francesco Milardi, MD

  Veneto Institute of Oncology IRCCS

  STUDY CHAIR

Central Study Contacts

Massimo Ferrucci, MD PhD

CONTACT

049 821 5500; massimoferrucci@gmail.com

Daniele Passeri, MD

CONTACT

+39 333 383 9397; daniele.passeri.1995@gmail.com

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD PhD

Study Record Dates

• First Submitted: May 19, 2026
• First Posted: May 29, 2026
• Study Start: May 1, 2026
• Primary Completion (Estimated): May 1, 2027
• Study Completion (Estimated): December 31, 2027
• Last Updated: May 29, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will share

Locations

IT (1)