Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer

NCT03747042 | Completed Phase 2 Results DMC FDA Drug

• 1 other identifier: SCCC-11118; STU-2018-0015
• Study Type: interventional
• Target: 61
• Locations: 1 country
• Sites: 1

Brief Summary

A short pre-surgical non-therapeutic trial involving postmenopausal women with newly diagnosed eR+, HeR2-negative operable breast cancers. After undergoing a core needle biopsy for tissue acquisition, study participants will take a 7- to 30-day (1-4 weeks) course of letrozole in accordance with standard of care. They will then undergo definitive surgical resection of their primary tumor (mastectomy vs lumpectomy) as per standard of care guidelines.

Conditions

Breast Cancer Female

Keywords

ER-positive; HER2-negative; invasive mammary carcinoma

Outcome Measures

Primary Outcomes (1)

• Measure Ki67 Index in Highly Hormone-dependent Breast Cancers vs. Those That Are Not

  Ki67 index measured 1-4 weeks after therapy with letrozole to segregate hormone receptor-positive breast cancers that are highly hormone-dependent vs. those that are not

  Within 8 to 30 days

Study Arms (1)

Treatment

EXPERIMENTAL

Drug: letrozole Take by mouth at a dose of 2.5 mg on days 7-30 Other: Blood Collection Blood used for gene expression analysis and reverse transcriptase-polymerase chain reaction Procedure: biopsy/lumpectomy/mastectomy Tissue collection,Surgery to remove tumor, Tumor tissues used for laboratory biomarker analysis

Drug: Letrozole

Interventions

Letrozole DRUG

Patients will receive a prescription for letrozole to be taken orally for 7-30 days to allow for variations in surgical scheduling. Patients are to undergo surgical resection of their tumor the day after the last dose of letrozole. Post-treatment tumor biopsies (a goal of 4-6 cores) will be obtained following 7-56 days of letrozole treatment on the day of surgery.

Treatment

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• Patients must provide informed written consent
• ECOG performance status 0-2.
• 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
• 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
• 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)
• No prior chemotherapy for this primary breast cancer.
• Patients with a prior history of contralateral breast cancer are eligible if they have no evidence of recurrence of their initial primary breast cancer.
• 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.
• 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.

Sponsors & Collaborators

• University of Texas Southwestern Medical Center: lead
• Cancer Prevention Research Institute of Texas: collaborator

Study Sites (1)

Simmons Comprehensive Cancer Center at University of Texas Southwestern Medical Center - Dallas

Dallas, Texas, 75390, United States

Location

MeSH Terms

Interventions

Letrozole

Intervention Hierarchy (Ancestors)

Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds

Results Point of Contact

• Title: Dr. Nisha Unni
• Organization: University of Texas Southwestern Medical Center

nisha.unni@utsouthwestern.edu

214-648-4180

Study Officials

• Nisha Unni, MD

  University of Texas Southwestern Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Study Record Dates

• First Submitted: November 15, 2018
• First Posted: November 20, 2018
• Study Start: November 27, 2018
• Primary Completion: February 24, 2025
• Study Completion: February 24, 2025
• Last Updated: March 16, 2026
• Results First Posted: March 16, 2026

Record last verified: 2025-02

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)