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To evaluate the response of Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor-Positive Breast Cancer Patients not a candidate for Chemotherapy: A pilot study.

To evaluate the response of Neoadjuvant Endocrine Therapy in Locally Advanced Hormone Receptor-Positive Breast Cancer Patients not a candidate for Chemotherapy: A pilot study.

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2026/07/113851
Enrollment
45
Registered
2026-07-13
Start date
Unknown
Completion date
Unknown
Last updated
2026-08-03

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: C509- Malignant neoplasm of breast of unspecified site

Interventions

Intervention1: neo adjuvant chemotherapy agent- Tab letrozole: Patient will receive neo adjuvant chemotherapy( aromatase inhibitor) in the the form of oral tablets of letrozole 2.5 mg daily for 6 mont

Sponsors

DR JAGRATI YADAV
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Women with histologically confirmed locally advanced, hormone receptor-positive (ER+ and/or PR+), HER2-negative breast cancer. 2. Women not suitable for chemotherapy due to age, comorbidities, or personal preference. 3. Women with adequate organ function. 4. Women with ECOG performance status of 0-2

Exclusion criteria

Exclusion criteria: 1. Women with prior treatment for the current breast cancer diagnosis. 2. Women with bilateral breast cancer 3. Women with inflammatory breast cancer 4. Women with metastatic breast cancer 5. Women with contraindications to endocrine therapy, and 6. Women not willing to sign informed consent form.

Design outcomes

Primary

MeasureTime frame
To assess the clinical response rate to neoadjuvant endocrine therapy in patients with locally advanced HR+ breast cancer who are not candidates for chemotherapy. Timepoint: 3 and 6 months

Secondary

MeasureTime frame
To assess safety & tolerability of NET in elderly patients. To evaluate its impact on surgical outcomes. To identify biomarker predictives of response to NET in population.Timepoint: at 3 & 6 months

Countries

India

Contacts

Public ContactDR JAGRATI YADAV

DMIMS

amolpgi@yahoo.co.in9823311569

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Aug 10, 2026