Short course of letrozole before surgery may reveal breast Cancer's hormone dependence
NCT ID NCT03747042
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This completed Phase 2 trial enrolled 61 postmenopausal women with operable, hormone-sensitive breast cancer. Participants took letrozole for 7 to 30 days before their scheduled surgery. The goal was to measure changes in a tumor marker called Ki67 to see which cancers are highly hormone-dependent. The study did not aim to treat the cancer directly but to gather information that could guide future treatment decisions.
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 successful, this could help doctors identify which breast cancers are highly hormone-dependent and may respond best to letrozole treatment.
- What could go wrong
- This is a small, early-phase study with only 61 participants, and it measures a biomarker (Ki67) rather than long-term outcomes like survival or recurrence.
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
-
Phase 2
Tests whether the treatment actually works, and watches for side effects, in a larger group.
- Participants
-
61 people
The number who actually took part.
- Started
-
Nov 2018
- Finished
-
Feb 2025
- Lead sponsor
-
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
-
18 years and older
- Sex
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Female participants only
- Healthy volunteers
-
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. Eligibility waivers are not permitted. Subjects must meet all of the inclusion and exclusion criteria to be registered to the study. Study treatment may not begin until a subject is registered. 2. Patients must provide informed written consent 3. ECOG performance status 0-2. 4. Clinical stage operable I, II or III invasive mammary carcinoma, which is ER-positive by IHC and HER2-negative by Herceptest (0 or 1+) or not amplified by in situ hybridization as per routine clinical testing. * Patients who have measurable residual tumor at the primary site * Patients who will undergo surgical treatment with either segmental resection or total mastectomy 5. Measurable tumor. Measurable disease: a mass that can be reproducibly measured by physical exam, mammogram or ultrasound and is at least 1 cm in size 6. Post-menopausal female subjects ≥18 years of age, as defined by any of the following: * Subjects at least 55 years of age; * Subjects under 55 years of age and amenorrhoeic for at least 12 months or follicle-stimulating hormone (FSH) values ≥40 IU/L and estradiol levels ≤40 pg/mL (140 pmol/L) or in postmenopausal ranges per local or institutional reference ranges; * Prior bilateral oophorectomy or prior radiation castration with amenorrhea for at least 6 months. * (There is no upper age limit for enrollment to this study) 7. No prior chemotherapy for this primary breast cancer. 8. Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer. 9. Women may have been taking tamoxifen or raloxifene as a preventive agent prior to study entry but must have discontinued the drug for at least 14 days prior to study enrollment. 10. Subjects must have ended hormone replacement therapy (HRT) (e.g., conjugated estrogens tablets, USP, \[Premarin\]), at least 7 days prior to receiving the first dose of randomized therapy. 11. Patients must have adequate hepatic and renal function. All tests must be obtained less than 4 weeks from study entry. This includes: 1. Creatinine \<2X upper limits of normal 2. Bilirubin, SGOT, SGPT \<1.5X upper limits of normal 12. Able to swallow and retain oral medication Exclusion Criteria: 1. Patients with locally advanced disease who are candidates for other preoperative chemotherapy at the time of initial evaluation. This may include patients with locally advanced disease such as: * Inflammatory breast cancer (T4d) * Fixed axillary lymph node metastases (N2) * Metastasis to ipsilateral internal mammary node (N3) 2. Locally recurrent breast cancer 3. Evidence of distant metastatic disease (i.e. lung, liver, bone, brain, etc.) 4. Serious medical illness that in the judgment of the treating physician places the patient at high risk of operative mortality. 5. Severe uncontrolled malabsorption condition or disease (i.e. grade II/III diarrhea, severe malnutrition, short gut syndrome) 6. Dementia, altered mental status, or any psychiatric condition that would prohibit the understanding or rendering of informed consent. 7. Use of an investigational drug within 30 days or 5 half-lives, whichever is longer, preceding the first dose of letrozole.
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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.
Contacts and locations
Locations
-
Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas
Dallas, Texas, 75390, United States
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