Neo-Adjuvant Endocrine Therapy in Post-Menopausal Hormone Receptor Positive HER 2 Neu Negative Node Positive Early-Stage Breast Cancer Patients With One Year of Letrozole. (NELOPHER)

NCT07394946 Phase 2 NOT_YET_RECRUITING

The goal of this clinical trial is to learn whether letrozole, a hormone therapy drug, is effective in treating early-stage, hormone receptor-positive, HER2-negative breast cancer that has spread to nearby lymph nodes in postmenopausal women. The study will also evaluate the safety of taking letrozole for one year before surgery. The main questions this study aims to answer are: Can one year of letrozole eliminate cancer from the underarm (axillary) lymph nodes? Can treatment with letrozole reduce the need for extensive lymph node surgery? How safe and tolerable is long-term letrozole treatment? This is a single-arm study, meaning all participants will receive letrozole. There is no placebo or comparison group. Participants will: Take letrozole 2.5 mg by mouth once daily for one year Attend regular clinic visits for physical exams, blood tests, and imaging studies Undergo surgery after completing treatment Be followed for up to two years to monitor cancer recurrence and survival

Details

Lead sponsor	Cancer Care Hospital & Research Centre Foundation, Lahore
Phase	Phase 2
Status	NOT_YET_RECRUITING
Enrolment	126
Start date	2026-06
Completion	2029-07

Conditions

• Hormone Receptor-Positive, HER2-Negative, Node Positive Breast Cancer

Interventions

• Letrozole

Primary outcomes

• Extent of Axillary Nodal Pathologic Complete Response (pCR) — From baseline (pre-treatment) to the end of one-year letrozole treatment
  Proportion of postmenopausal, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer patients achieving pathological complete response (pCR) in axillary lymph nodes after one year of neoadjuvant letrozole therapy, assessed by sentinel lymph node biopsy (SLNBx).

Countries

Pakistan