Breast cancer is the most frequently diagnosed malignancy and the leading cause of cancer-related mortality among women worldwide and in India [1]. It is a highly heterogeneous disease comprising distinct molecular and histological subtypes that dictate clinical behavior, treatment strategies, and survival outcomes. Among these, triple-negative breast cancer (TNBC)—defined by the lack of expression of estrogen receptor (ER), progesterone receptor (PR), and human epidermal growth factor receptor 2 (HER2/neu)—represents approximately 10% to 20% of all breast carcinomas globally [2].

However, epidemiological data from India consistently suggest a higher prevalence of TNBC, ranging from 20% to 31% of all breast cancer cases [3]. This elevated proportion is coupled with distinct clinical challenges. Compared to non-TNBC subtypes, TNBC is characterized by an aggressive clinical course, high recurrence rates, a propensity for early visceral metastasis (particularly to the brain and lungs), and the absence of targeted endocrine or anti-HER2 therapeutic options [4]. Consequently, systemic chemotherapy remains the backbone of medical management.

Regional variations in breast cancer demographics, socioeconomic factors, and access to healthcare infrastructure in India significantly impact clinical presentation and outcomes. The Acharya Harihar Postgraduate Cancer Centre (AHPGCC) in Cuttack, Odisha, serves as the premier regional tertiary care oncology hub for Eastern India. The patient population in this region is predominantly rural, facing socioeconomic challenges, limited local healthcare infrastructure, and low awareness of cancer screening programs [5].

Although studies from metropolitan centers in India have explored the profiles of TNBC, descriptive epidemiological data from the semi-urban and rural demographics of Eastern India remain sparse. Understanding the localized clinical presentation, tumor biology, and treatment compliance of TNBC is critical for designing customized public health strategies and optimizing clinical protocols. Therefore, this study was designed to retrospectively evaluate the clinico-pathological profile, demographic variations, and treatment patterns of TNBC patients presenting to our tertiary oncology center.

Study Design and Setting This was a retrospective, single-center, descriptive observational study conducted in the Department of Medical Oncology and Pathological Sciences at the Acharya Harihar Postgraduate Cancer Centre (AHPGCC), Cuttack, Odisha. AHPGCC is a government-run, dedicated regional tertiary oncology center serving Eastern Indian states, particularly Odisha, West Bengal, and Jharkhand. Study Population and Eligibility The study population comprised patients diagnosed with primary breast cancer between January 2022 and December 2024. Patients were selected based on the following criteria: • Inclusion Criteria: 1. Histologically confirmed invasive breast carcinoma. 2. Immunohistochemically (IHC) confirmed triple-negative status, defined according to the American Society of Clinical Oncology/College of American Pathologists (ASCO/CAP) guidelines:  ER negative (nuclear staining in < 1% of tumor cells).  PR negative (nuclear staining in < 1% of tumor cells).  HER2 negative (IHC score of 0 or 1+, or IHC score of 2+ with negative fluorescence in situ hybridization [FISH] or chromogenic in situ hybridization [CISH]). 3. Non-metastatic disease (Stage I to III) at the time of initial clinical evaluation. 4. Availability of complete electronic or paper medical charts, pathology reports, and treatment details. • Exclusion Criteria: 1. Bilateral or synchronous primary breast malignancies. 2. Recurrent breast cancer at presentation. 3. Prior history of pelvic radiation or systemic chemotherapy for other malignancies. 4. Incomplete or inaccessible medical records, or patients who defaulted prior to initiating any cancer-directed therapy. Applying these criteria resulted in a final cohort of N = 86 patients. Data Collection Data were extracted from the medical records archive of AHPGCC. Collected variables included: • Demographic Data: Age at presentation, menopausal status, and geographic origin (rural vs. urban, defined based on administrative zoning). • Clinical Features: Laterality of the tumor, clinical tumor size, and presence of palpable axillary lymphadenopathy. • Pathological Features: Histological subtype (Invasive Ductal Carcinoma [IDC] vs. other subtypes), histological grade according to the Scarff-Bloom-Richardson (SBR) grading system, pathological tumor stage (pT), and pathological node stage (pN) as per the American Joint Committee on Cancer (AJCC) 8th Edition staging manual. • Treatment Patterns: Administration of neoadjuvant chemotherapy (NACT) versus adjuvant chemotherapy, type of surgical intervention (Modified Radical Mastectomy [MRM] vs. Breast Conservation Surgery [BCS]), chemotherapy regimens received, and use of adjuvant radiotherapy. Immunohistochemical Analysis All tissue specimens (core needle biopsies or surgical resections) had undergone standard formalin fixation and paraffin embedding. IHC staining was performed using standardized primary antibodies against ER, PR, and HER2/neu. Positive and negative controls were included in each run to ensure staining quality. Statistical Analysis Statistical analysis was performed using SPSS software (Version 26.0, IBM Corp, Armonk, NY, USA). Descriptive statistics were used to summarize the data. Continuous variables (such as age) were reported as mean +/- standard deviation (SD). Categorical variables (such as stage, grade, menopausal status, treatment type) were presented as absolute frequencies and percentages. Associations between clinical parameters (e.g., age groups, menopausal status, and clinical stage) were analyzed using the Pearson Chi-Square test or Fisher’s exact test where appropriate. A p-value < 0.05 was considered statistically significant.

The clinical and demographic parameters of the N = 86 patients are summarized in Table 1. The mean age of the cohort at diagnosis was 46.8 +/- 10.2 years (range: 28 to 71 years). The highest incidence of TNBC was observed in the 41 to 50 age group (41.9%, n = 36), followed by those aged le 40 years (27.9%, n = 24). Over half of the cohort was pre-menopausal (55.8%, n = 48) at presentation.

A major portion of the study population belonged to rural regions of Odisha and neighboring states (72.1%, n = 62). Left-sided breast cancer was slightly more common (52.3%, n = 45) than right-sided disease (47.7%, n = 41).

Table 1: Demographic and Clinical Characteristics of TNBC Cohort (N = 86)

Pathological Characteristics

Pathological findings demonstrated an aggressive tumor biology across the cohort (Table 2). Invasive Ductal Carcinoma, Not Otherwise Specified (IDC-NOS), was diagnosed in 95.3% (n = 82) of the patients. Rare histological variants, including metaplastic and medullary-like carcinomas, comprised the remaining 4.7% (n = 4).

High histological grade (Scarff-Bloom-Richardson Grade III) was dominant, accounting for 72.1% (n = 62) of all tumors, while Grade II made up 25.6% (n = 22) and Grade I was observed in only 2.3% (n = 2).

Pathological tumor size staging revealed that most patients had advanced local disease: 53.5% (n = 46) had T2 tumors (2 cm} < T le 5 cm}) and 25.6% (n = 22) had T3 tumors (> 5 cm}). Skin or chest wall involvement (T4) was identified in 11.6% (n = 10) of patients. Lymph node involvement was highly prevalent; 65.1% (n = 56) of the patients were pathologically node-positive (pN1, pN2, or pN3). Correspondingly, AJCC Stage II (52.3%, n = 45) and Stage III (41.9%, n = 36) accounted for the vast majority of cases at presentation, reflecting a substantial burden of locally advanced disease.

Table 2: Pathological Features and Treatment Patterns (N = 86)

Treatment Patterns

Therapeutic approaches utilized for the management of the cohort are outlined in Table 2. In terms of clinical sequencing, 37.2% (n = 32) of patients received neoadjuvant chemotherapy (NACT) to downstage locally advanced disease, whereas 62.8% (n = 54) underwent upfront surgical resection followed by adjuvant chemotherapy.

Modified Radical Mastectomy (MRM) was the predominant surgical procedure, performed in 79.1% (n = 68) of cases. Breast Conservation Surgery (BCS) was performed in only 20.9% (n = 18) of the patients.

Systemic chemotherapy regimens were heavily dominated by sequential anthracycline-taxane regimens (such as four cycles of Adriamycin/Cyclophosphamide followed by four cycles of Paclitaxel or Docetaxel), which were administered to 86.0% (n = 74) of patients. Anthracycline-only regimens (e.g., 5-Fluorouracil, Adriamycin, Cyclophosphamide [FAC]) were used in 9.3% (n = 8) of the patients, mostly due to cardiac comorbidities or age-related frailty.

Following surgery, adjuvant radiotherapy (RT) was administered to 74.4% (n = 64) of patients. This included all patients who underwent BCS and those post-MRM who had T3/T4 disease or ge 4 positive lymph nodes. However, 25.6% (n = 22) of the patients did not receive RT, which was largely attributed to treatment default, financial constraints, or logistical challenges associated with traveling from remote rural areas to the tertiary radiotherapy center.

This retrospective descriptive study highlights the demographic characteristics, pathological parameters, and treatment patterns of triple-negative breast cancer (TNBC) patients managed at a tertiary government cancer institute in Odisha. Our findings reveal several critical trends that differentiate Indian TNBC patients from Western populations, emphasizing the severe impact of socioeconomic and geographic factors on cancer presentation and care in Eastern India.

A major finding of this study is the remarkably young age at diagnosis in our cohort. The mean age of 46.8 +/- 10.2 years is substantially lower than the typical age reported in Western countries, where the median age of breast cancer diagnosis ranges between 60 and 62 years [6]. Furthermore, 27.9% of our patients presented at le 40 years of age. This younger age distribution is consistent with other Indian literature. A multi-center study by Sandhu et al. and retrospective reviews from Tata Memorial Hospital reported mean ages of breast cancer presentation between 45 and 49 years [7,8].

The high percentage of pre-menopausal TNBC patients (55.8%) in our study also mirrors this trend. TNBC has long been associated with younger age and a pre-menopausal status, a clinical phenotype that exhibits aggressive disease characteristics and poorer long-term prognoses.

A distinctive feature of our study is that 72.1% of the patients were from rural backgrounds. Acharya Harihar Postgraduate Cancer Centre is a major public referral hospital, which makes it the primary therapeutic resource for low-income and rural populations across Odisha.

Rural residence is heavily correlated with a lack of awareness of breast self-examination, absence of organized screening programs, local diagnostic delays, and prevailing social taboos regarding breast disease [9]. This rural-urban divide directly drives the advanced stage at presentation observed in our cohort, where a staggering 94.2% of patients presented with Stage II (52.3%) or Stage III (41.9%) disease. Similar delays in clinical presentation in low-income demographics have been widely reported in other developing countries, demonstrating a critical need for community-level intervention [10].

The pathological profile of our cohort confirms the aggressive biology inherent to TNBC. Consistent with global literature, IDC-NOS was the predominant histological subtype (95.3%), and the majority of patients exhibited high-grade tumors (SBR Grade III: 72.1%). High histological grade is a hallmark of TNBC, representing rapid cellular proliferation and a high mitotic index [11].

Additionally, 65.1% of our patients had pathologically confirmed lymph node metastases at the time of surgery. Axillary node positivity is an adverse prognostic indicator, and its high rate in this descriptive cohort underscores the systemic threat posed by TNBC, which frequently bypasses localized steps to disseminate hematogenously [12].

Our study demonstrated that Modified Radical Mastectomy (MRM) remains the primary surgical strategy, utilized in 79.1% of cases, while Breast Conservation Surgery (BCS) was performed in only 20.9%. In high-income countries, BCS followed by adjuvant radiotherapy is the standard of care for a majority of early and downstaged breast cancers, offering survival outcomes equivalent to MRM with improved quality of life [13].

However, in our setting, several barriers prevent the adoption of BCS. First, the advanced stage and larger tumor size at presentation often make BCS oncologically unsafe without significant response to NACT. Second, and perhaps more importantly, BCS mandates adjuvant radiotherapy to minimize local recurrence. Because patients from remote rural areas face severe logistical and financial challenges in finding long-term lodging near a tertiary center to complete a multi-week course of daily radiotherapy, clinicians and patients frequently opt for MRM as a definitive, one-time treatment [14].

Because TNBC lacks hormone receptors and HER2 amplification, systemic chemotherapy is the primary medical intervention. In our study, sequential anthracycline and taxane-based regimens were administered to 86.0% of patients. This is the global standard of care, offering the best pathological complete response (pCR) and disease-free survival rates in TNBC [15].

Despite clinical protocols being highly standardized, real-world treatment delivery face compliance hurdles. In our cohort, 25.6% of patients failed to complete or receive recommended adjuvant radiotherapy. This rate of default highlights a crucial systemic gap in tertiary cancer care in Eastern India. The centralization of oncology services in state capitals (such as Cuttack) places an unsustainable financial and physical burden on rural patients, leading to high default rates during the adjuvant phase of treatment [16].

This study has certain limitations. It was a retrospective, single-center study, which may introduce selection bias and limit the generalizability of the findings to the entirety of Eastern India. The sample size (N = 86), while representative of a continuous oncology registry, is modest.

Furthermore, because the study was descriptive in design, we did not report survival outcomes (such as Disease-Free Survival or Overall Survival) or analyze pathological complete response (pCR) rates in patients who underwent NACT. Long-term follow-up studies are ongoing to evaluate survival metrics and identify independent prognostic markers in this cohort.

This study provides valuable real-world insight into the clinico-pathological profile of triple-negative breast cancer in Eastern India. TNBC patients presenting to AHPGCC, Cuttack, are characterized by a young age at presentation, pre-menopausal status, rural background, high-grade histologies, and advanced clinical stage. Modified Radical Mastectomy and sequential anthracycline-taxane chemotherapy remain the mainstays of treatment. Our findings emphasize that reducing TNBC-related mortality in Eastern India will require more than importing advanced therapeutic agents. It demands a systematic expansion of decentralized diagnostic facilities, the implementation of localized awareness campaigns to detect tumors early, and robust support systems to reduce treatment default rates among rural populations. Acknowledgments The authors would like to acknowledge the administrative support of the Acharya Harihar Postgraduate Cancer Centre, Cuttack, and the clinical registries team for maintaining the patient database. Conflicts of Interest The authors declare no conflicts of interest regarding this manuscript.

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