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 range
18 Years – 69 Years
Sex
FEMALE
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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