Could a year of hormone pills before surgery spare lymph nodes in breast cancer?
NCT ID NCT07394946
First seen Jun 25, 2026 · Last updated Jun 27, 2026 · Updated 1 time
Summary
This study tests whether taking letrozole, a hormone therapy pill, for one year before surgery can shrink tumors and clear cancer from lymph nodes in postmenopausal women with early-stage, hormone-sensitive breast cancer. All 126 participants will take letrozole daily and then have surgery. The goal is to see if this approach reduces the need for extensive lymph node removal and is safe.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- letrozole
- What this could lead to
- If it works, this could show that taking letrozole for a year before surgery can eliminate cancer in lymph nodes and reduce the need for extensive lymph node removal.
- What could go wrong
- This is a small, early-phase study with no comparison group, so results may not be conclusive. Long-term hormone therapy can cause side effects like joint pain and bone thinning.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
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About 126 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jun 2026
An estimate. Start dates often move.
- Expected to finish
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Jul 2029
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 69 years
- Sex
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Female participants only
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Age: Patients aged 18 to 69 years. 2. Menopausal Status: All patients must be postmenopausal, confirmed by serum estradiol levels or other clinical criteria. 3. Diagnosis: Histologically confirmed infiltrating ductal carcinoma of any grade. 4. Tumor Size: Primary tumor (T) category of T1 or T2 according to AJCC 8th edition, as measured by ultrasonography (USG) and mammography. 5. Node Involvement: N1 disease documented by clinical examination and USG, with histopathology confirmed by fine-needle aspiration cytology (FNAC) or core needle biopsy. 6. Hormone Receptor Status: Patients must be estrogen receptor (ER) positive and progesterone receptor (PR) positive/negative, with HER2 status negative. Exclusion Criteria: 1. Age: Patients aged under 18 or over 69 years. 2. Tumor Size: Patients with a primary tumor larger than T2 \>5cm or with N2 disease. 3. Histological Type: Infiltrating lobular carcinoma or other non-invasive breast cancer types. 4. Prior Treatments: Previous treatment with neoadjuvant endocrine therapy (NET) or neoadjuvant chemotherapy (NACT). 5. Comorbidities: Significant comorbidities that preclude administration of anesthesia or compromise patient safety. 6. Disease Characteristics: Patients with multicentric or multifocal disease, as defined by imaging or histopathological findings.
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The places running it
1 site. The list below names each one and where it is.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
Contacts and locations
Locations
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Cancer Care Hospital and Research Centre Foundation
Lahore, Punjab Province, 54000, Pakistan