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Triple drug attack shrinks breast tumors before surgery

NCT ID NCT02520063

Disease control Sponsor: University of Alabama at Birmingham Source: ClinicalTrials.gov ↗

What the study statuses mean

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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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 study tested a combination of three drugs (letrozole, everolimus, and TRC105) given before surgery to postmenopausal women with hormone-receptor-positive, HER2-negative breast cancer. The goal was to see if the combo was safe and could shrink tumors. Fifteen women with stage 2 or 3 breast cancer took part. The results help guide future treatment approaches but do not offer a cure.

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 1/2

Runs two stages together: safety and dose first, then whether the treatment works.

Participants

15 people

The number who actually took part.

Started

Feb 2015

Finished

Dec 2022

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

19 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: * Recent diagnosis of hormone receptor positive and HER2 negative breast cancer. * Stage 2 and 3 hormone receptor positive and HER2 negative breast cancer (stage T2-4 but not inflammatory, N0-2, M0). * Histological grade I, II or III according to the modified Bloom Richardson scale. * No prior treatment specific for breast cancer. * Postmenopausal status as defined by the National Comprehensive Cancer Network. * ECOG performance status \< 2 (Karnofsky \> 60%). * Must have signed study-specific informed consent. * Liver Function Tests \< 2.5 times the upper normal limit (UNL). * ANC ≥ 1,500/mm3, platelets ≥ 100,000/mm3, Hemoglobin ≥ 10g%. * Renal function: serum creatinine \< 1.5 institutional UNL or creatinine clearance \> 40 cc/min. Exclusion Criteria: * Inflammatory breast cancer. * Pre- and peri-menopausal state. * Pregnancy. * Metastatic disease. * HER2 positive breast cancer by immunohistochemistry or FISH. * Triple negative breast cancer (hormone receptor and Her2 negative). * Disease that cannot be followed by imaging studies.

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Conditions

The condition(s) this trial relates to.

breast cancer breast neoplasm hormone receptor-positive breast cancer

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Breast cancer

Contacts and locations

Locations

  • University of Alabama at Birmingham

    Birmingham, Alabama, 35294, United States

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