NELOPHER
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.
Sponsor study identifier
interventional
126
1 country
1
Study Start
June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
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
Registry-reported information. Elapsed time and enrollment totals alone do not measure study progress or recruitment pace.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Click on a node to explore related trials.
Dates and qualifiers reported by the registry. Estimated dates do not confirm that a milestone has occurred.
January 31, 2026
Actual (reported)February 6, 2026
Actual (reported)June 2026
Estimated (date passed)This estimate has passed. The registry has not confirmed an actual date for this milestone.
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Extent of Axillary Nodal Pathologic Complete Response (pCR)
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).
From baseline (pre-treatment) to the end of one-year letrozole treatment
Loco-Regional Relapse Rate
Assessed at 6, 12, and 24 months post-treatment initiation
Distant Relapse Rate
Assessed at 6, 12, and 24 months post-treatment initiation
Safety and Tolerability
Monitored continuously during the 1-year treatment period, reported at 3-month intervals.
Letrozole, Oral, 2.5mg daily, for 1 year
Letrozole is an oral aromatase inhibitor administered at a dose of 2.5 mg once daily for one year. It is used as neoadjuvant therapy in postmenopausal women with early-stage, hormone receptor-positive (ER+/PR+), HER2-negative, node-positive breast cancer to reduce tumor size and axillary lymph node involvement before surgery.
Cancer Care Hospital and Research Centre Foundation
Lahore, Punjab Province, 54000, Pakistan
First Submitted
January 31, 2026
First Posted
February 6, 2026
Study Start
June 2026
Estimated (date passed)Contact the study team to confirm eligibility.
This estimate has passed. The registry has not confirmed an actual date for this milestone.
Primary Completion
July 2027
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Study Completion
July 2029
EstimatedPlanned date reported by the registry; this milestone is not confirmed as achieved.
Last Updated
February 20, 2026
Record last verified: 2026-01
IPD will not be shared due to patient privacy and institutional data protection policies. Aggregate study results will be made publicly available through ClinicalTrials.gov and peer-reviewed publications.
Download the complete ClinicalTrials.gov record imported by Syfrah, including fields not shown in this page. The registry may contain a newer revision.
Source: ClinicalTrials.gov.
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