Prospective Analysis and outcome of Breast tuberculosis in endemic area

INTRODUCTION

Breast tuberculosis (BTB) is an uncommon but clinically important manifestation of extrapulmonary tuberculosis. Globally, it accounts for fewer than 1% of breast lesions, though its incidence rises to 3–4% in regions with high tuberculosis prevalence such as India, sub-Saharan Africa, and Southeast Asia.^1,2 The condition is seen most frequently in women of reproductive age and is often mistaken for other breast disorders, particularly carcinoma or pyogenic abscesses, which complicates timely diagnosis. Patients may present with diverse symptoms including painful nodules, ulceration, sinus tract formation, or features resembling mastitis. Because of its nonspecific clinical profile and the limited awareness among clinicians, BTB is frequently misdiagnosed, resulting in delays in appropriate treatment.^2,3

The pathogenesis of Breast tuberculosis may involve direct inoculation, lymphatic spread from axillary or mediastinal nodes, or hematogenous dissemination from a primary focus from other sites in the body. Diagnosis relies heavily on histopathological confirmation, as microbiological tests such as smear and culture often yield low sensitivity in breast tissue samples.^4,5 Imaging modalities like ultrasonography and mammography may aid in evaluation but are not definitive.^6,7

In endemic areas, the burden of tuberculosis remains high, and the incidence of atypical presentations like Breast tuberculosis is increasingly recognized. Despite its rarity, Breast tuberculosis poses diagnostic and therapeutic dilemmas, particularly in resource-limited setup where advanced diagnostic modalities are limited. Treatment typically involves standard anti-tubercular therapy (ATT), with surgical intervention reserved for diagnostic or therapeutic purposes. Early diagnosis and prompt initiation of anti-tubercular therapy (ATT) are crucial for favorable outcomes. However, literature on the clinical spectrum, diagnostic strategies, and treatment outcomes of Breast tuberculosis remains limited, particularly from prospective studies in high-burden regions.

This prospective study was undertaken to analyze the clinical presentation, diagnostic approach, outcome of management, and follow-up of diagnosed cases of breast tuberculosis at a tertiary care hospital in an endemic region. By systematically evaluating these parameters, the study aims to enhance clinical awareness and contribute to evidence-based insights into management strategies for this uncommon but important disease.

METHODS

Study Design and Ethical Approval

This was a prospective observational study conducted at a tertiary care hospital between January 2021 and November 2025. Approval was obtained from the Institutional Ethics Committee prior to commencement. Written informed consent was secured from all participants at the time of enrolment.

Participants

Women presenting with clinical features suggestive of breast tuberculosis in the outpatient department or during hospital admission were recruited. Inclusion required willingness to attend follow-up visits.

Patients were excluded if they had Abnormal liver function tests, Cardiac disease, Pregnancy or lactation. These exclusions were applied to safeguard patient health and reduce potential confounders.

Data Collection

Baseline demographic information (age, past or contact history of tuberculosis, and comorbidities) was recorded. Clinical presentation, diagnostic approach, and treatment details were documented. Radiological evaluation included breast ultrasonography (USG) and/or mammography. Screening for pulmonary tuberculosis was performed using chest radiography and culture of respiratory secretions.

Diagnostic Criteria

Diagnosis was confirmed by histopathological examination of tissue obtained through:

• Core needle biopsy

• Incisional or excisional biopsy of ulcers

• Abscess wall biopsy during drainage procedures

The presence of epithelioid granulomas, Langhans’ giant cells, and lymphohistiocytic aggregates was considered diagnostic of breast tuberculosis.

Treatment Protocol

All patients received a standard anti-tubercular regimen consisting of:

Isoniazid: 5 mg/kg/day (maximum 300 mg/day)

Rifampicin: 10 mg/kg/day (maximum 600 mg/day)

Duration: 6 months

For the initial 2 months, therapy was supplemented with:

Pyrazinamide: 20–30 mg/kg/day (maximum 2 g/day)

Streptomycin: 15 mg/kg/day (maximum 1 g/day) or

Ethambutol: 15–20 mg/kg/day (maximum 1.5 g/day)

If symptoms persisted and Mycobacterium tuberculosis was isolated, treatment was extended by an additional 3 months.

Follow-up

Patients were reviewed monthly for one year. Complications and treatment outcomes were systematically recorded at each visit.

Statistical Analysis

Data analysis was performed using IBM SPSS Statistics version 24.0 (IBM Corp., Armonk, NY, USA). Continuous variables were expressed as Mean ± SD (range). Categorical variables were summarized as percentages.

RESULTS

A total of 28 patients were confirmed to have breast tuberculosis during the study period. All were non-lactating women. The age distribution ranged from 20 to 50 years, with the 30–40 year group being most affected (53.6%, n=15), followed by the 20–30 year group (28.6%, n=8). The mean age was 35.2 years. The average duration of symptoms prior to diagnosis was 36.5 days (range: 0–130 days). All cases were unilateral, with 19 (67.9%) involving the right breast and 9 (32.1%) the left breast.

The predominant presentation was mastitis (painful lump with fever) in 35.7% (n=10), followed by breast ulcers in 25% (n=7) (Table 1). None of the patients reported a prior history of tuberculosis, and all were sputum-negative for pulmonary TB.

Ultrasonography was performed in all patients and revealed abnormal findings in every case. Mammography was feasible in only 5 patients (17.9%), mainly due to age restrictions.

Among patients with breast lumps (n=15, 53.6%), fine-needle aspiration cytology (FNAC) was performed. Although all FNAC samples were stained for acid-fast bacilli, none were positive. Definitive diagnosis was achieved through histopathology in all cases.

Core needle biopsy was the most common method (n=15, 53.6%) with an accuracy of 93.5%.

Excisional biopsy was required in 3 patients (10.7%) when core biopsy was inconclusive.

Edge biopsy was performed in 7 patients (25%) with breast ulcers.

Incisional biopsy from abscess walls was carried out in 5 patients (17.9%).

Smear examination of nipple discharge was done in 2 patients, both showing positive Ziehl–Neelsen staining.

Histopathological findings included epithelioid granulomas, multinucleated giant cells, and in some cases, caseous necrosis.

Treatment and follow-up

All patients received a 6-month antitubercular regimen:

Intensive phase (2 months): isoniazid, rifampicin, pyrazinamide, and ethambutol (HRZE)

Continuation phase (4 months): isoniazid and rifampicin (HR)

Patients were followed monthly for at least 1 year with clinical and ultrasonographic evaluation.

All participants completed therapy successfully. No adverse drug reactions were reported, and none discontinued treatment. Clinical improvement was observed in all cases, with resolution of pain, discharge, and breast lumps. Follow-up ultrasonography confirmed absence of residual abscesses or collections, and all patients resumed a normal lifestyle without persistent symptoms.

DISCUSSION

Breast tuberculosis remains a uncommon manifestation of extrapulmonary tuberculosis, particularly in non-lactating women.⁸ This prospective study conducted over nearly five years at a tertiary care center highlights the clinical spectrum, diagnostic challenges, and treatment outcomes of breast tuberculosis in a cohort of 28 patients. The demographic profile in our study aligns with previous literature,^1,2,9,10 showing a predominance in women aged 30 - 40 years that identify reproductive age women as the most vulnerable group. The unilateral presentation, especially on the right side (67.86%), is consistent with earlier reports, though the reason for lateral predilection remains unclear.^2,9,10

The most common clinical presentation was mastitis-like symptoms (painful lump with fever), followed by breast ulcers. These findings align with other studies that describe breast tuberculosis as presenting with nodular, ulcerative, or abscess-forming lesions.¹⁰ Clinically, mastitis-like symptoms and breast ulcers often mimicking pyogenic infections or malignancy. This underscores the diagnostic dilemma posed by breast tuberculosis, especially in endemic regions where awareness may be limited.^4,5 Notably, no case had a prior history of tuberculosis or evidence of pulmonary tuberculosis, reinforcing the importance of considering breast tuberculosis even in the absence of systemic tuberculosis (TB) symptoms.

In our study, imaging investigations, particularly breast ultrasonography, proved valuable in identifying abnormal findings, although mammography was limited due to age constraints. FNAC, while commonly used, failed to yield definitive results in our cohort, highlighting its limited sensitivity in breast tuberculosis, echoing literature that questions its sensitivity in breast tuberculosis. Histopathological examination remained the cornerstone of diagnosis, with core needle biopsy proved most reliable. The presence of epithelioid granulomas, multinucleated giant cells, and caseous necrosis were hallmark features confirming tuberculosis etiology.^1,2,4,5

All patients responded to standard antitubercular treatment (ATT), with a 6-month regimen proving effective. This supports existing treatment protocols that recommend HRZE for 2 months followed by HR for 4 months, with extensions in cases of persistent symptoms. Monthly follow-up ensured early detection of complications and assessment of treatment efficacy.^9–11

Breast tuberculosis, though rare, presents a diagnostic challenge due to its nonspecific clinical and radiological features. This study reinforces the importance of maintaining a high index of suspicion in endemic areas, especially in non-lactating women presenting with chronic breast lesions. Histopathological confirmation remains the cornerstone of diagnosis, with core needle biopsy offering high diagnostic yield. Standard anti-tubercular therapy is effective, and timely treatment leads to excellent outcomes.

The absence of recurrence or residual disease at one-year follow-up further supports the adequacy of the six-month regimen.

Our findings emphasize several key points:

• Breast tuberculosis should be suspected in women presenting with chronic mastitis, breast ulcers, or non-resolving lumps, particularly in endemic regions.

• Histopathological confirmation remains the cornerstone of diagnosis, as cytology and imaging are often inconclusive.

• Standard antitubercular therapy is highly effective, with excellent clinical outcomes and minimal complications.

The study’s strengths include its prospective design, comprehensive diagnostic approach.

Limitations

This study has several limitations that should be acknowledged. First, it was conducted at a single tertiary care center, which may limit the generalizability of the findings to broader populations. Second, the sample size was relatively small (n=28), Third, although histopathology was used as the gold standard for diagnosis, molecular techniques such as PCR or GeneXpert were not employed. Fourth, radiological evaluation was limited, as mammography could not be performed in younger patients, potentially reducing comparative imaging data. Fifth, the follow-up period was restricted to one year, which may not capture late recurrences or long-term complications.

CONCLUSION

Breast tuberculosis should be considered in the differential diagnosis of chronic breast lesions, especially in tuberculosis endemic regions. Early histopathological confirmation and prompt initiation of antitubercular treatment are critical for favorable outcomes. Greater awareness among clinicians and integration of advanced diagnostics may further improve case detection and management.

Conflict of Interest

None

Financial Support

None