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Negative Hormone Receptor and APOcrine Lobular Invasive Breast Cancer

ConditionLobular Breast Carcinoma
Trial statusRecruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age18+
SponsorIstituto Oncologico Veneto IRCCS

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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.

Trial 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.

Trial design

Design model

Cohort

Time perspective

Retrospective

Treatments tested in this trial

  • Upfront Breast Surgery

    Procedure/Surgery

    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

Treatment groups

No treatment groups listed

Trial outcomes

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.

Time frame
Through study completion, an average of 5 years

Secondary outcomes

1

Disease-Free Survival

Time frame
Through study completion, an average of 5 years
2

Overall Survival

Time frame
Through study completion, an average of 5 years
3

Recurrence Rate

Measured as local, regional or distant recurrence.

Time frame
Through study completion, an average of 5 years

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Istituto Oncologico Veneto IRCCS

Lead sponsor

Source ClinicalTrials.gov
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