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Short course of letrozole before surgery may reveal breast Cancer's hormone dependence

NCT ID NCT03747042

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

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

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

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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Other studies related to the condition(s) this trial covers.