Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node… (NCT07394946) | Clinical Trial Compass
Not Yet RecruitingPhase 2
Neoadjuvant Letrozole in Postmenopausal Women With Hormone Receptor-Positive, HER2-Negative, Node Positive, Early-Stage Breast Cancer.
Pakistan126 participantsStarted 2026-06
Plain-language summary
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
Who can participate
Age range18 Years – 69 Years
SexFEMALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
✓. Age: Patients aged 18 to 69 years.
✓. Menopausal Status: All patients must be postmenopausal, confirmed by serum estradiol levels or other clinical criteria.
✓. Diagnosis: Histologically confirmed infiltrating ductal carcinoma of any grade.
✓. Tumor Size: Primary tumor (T) category of T1 or T2 according to AJCC 8th edition, as measured by ultrasonography (USG) and mammography.
✓. Node Involvement: N1 disease documented by clinical examination and USG, with histopathology confirmed by fine-needle aspiration cytology (FNAC) or core needle biopsy.
✓. Hormone Receptor Status: Patients must be estrogen receptor (ER) positive and progesterone receptor (PR) positive/negative, with HER2 status negative.
Exclusion criteria
✕. Age: Patients aged under 18 or over 69 years.
✕. Tumor Size: Patients with a primary tumor larger than T2 \>5cm or with N2 disease.
✕
What they're measuring
1
Extent of Axillary Nodal Pathologic Complete Response (pCR)
Timeframe: From baseline (pre-treatment) to the end of one-year letrozole treatment
Trial details
NCT IDNCT07394946
SponsorCancer Care Hospital & Research Centre Foundation, Lahore