Trial Outcomes & Findings for Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer (NCT NCT03747042)
NCT ID: NCT03747042
Last Updated: 2026-03-16
Results Overview
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
Recruitment status
COMPLETED
Study phase
PHASE2
Target enrollment
61 participants
Primary outcome timeframe
Within 8 to 30 days
Results posted on
2026-03-16
Participant Flow
Participant milestones
| Measure |
Treatment
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
Letrozole: 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.
|
|---|---|
|
Overall Study
STARTED
|
61
|
|
Overall Study
COMPLETED
|
53
|
|
Overall Study
NOT COMPLETED
|
8
|
Reasons for withdrawal
| Measure |
Treatment
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
Letrozole: 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.
|
|---|---|
|
Overall Study
Adverse Event
|
1
|
|
Overall Study
Physician Decision
|
2
|
|
Overall Study
Withdrawal by Subject
|
1
|
|
Overall Study
Unable to complete surgery
|
2
|
|
Overall Study
Surgery delayed out of window
|
2
|
Baseline Characteristics
Letrozole in Post-Menopausal Patients With Operable Hormone-Sensitive Breast Cancer
Baseline characteristics by cohort
| Measure |
Treatment
n=61 Participants
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
Letrozole: 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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=10 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
29 Participants
n=10 Participants
|
|
Age, Categorical
>=65 years
|
32 Participants
n=10 Participants
|
|
Age, Continuous
|
66 years
n=10 Participants
|
|
Sex: Female, Male
Female
|
61 Participants
n=10 Participants
|
|
Sex: Female, Male
Male
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Asian
|
4 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Black or African American
|
12 Participants
n=10 Participants
|
|
Race (NIH/OMB)
White
|
45 Participants
n=10 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=10 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=10 Participants
|
|
Region of Enrollment
United States
|
61 participants
n=10 Participants
|
PRIMARY outcome
Timeframe: Within 8 to 30 daysKi67 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
Outcome measures
| Measure |
Treatment
n=53 Participants
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
Letrozole: 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.
|
|---|---|
|
Measure Ki67 Index in Highly Hormone-dependent Breast Cancers vs. Those That Are Not
High Ki67
|
40 Participants
|
|
Measure Ki67 Index in Highly Hormone-dependent Breast Cancers vs. Those That Are Not
Low Ki67
|
7 Participants
|
|
Measure Ki67 Index in Highly Hormone-dependent Breast Cancers vs. Those That Are Not
Intermediate Ki67
|
6 Participants
|
Adverse Events
Treatment
Serious events: 0 serious events
Other events: 3 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Treatment
n=61 participants at risk
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
Letrozole: 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.
|
|---|---|
|
Infections and infestations
Conjunctivitis
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Reproductive system and breast disorders
Vaginal Discharge
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Respiratory, thoracic and mediastinal disorders
Epistaxis
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Pain - Right shoulder
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Endocrine disorders
Hyperthyroidism
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Investigations
Alkaline phosphatase increased
|
4.9%
3/61 • Number of events 3 • 2 years and 11 months
|
|
Metabolism and nutrition disorders
Diarrhea
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Metabolism and nutrition disorders
Hypercalcemia
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Investigations
Creatinine Increased
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Vascular disorders
Hot flashes
|
3.3%
2/61 • Number of events 2 • 2 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Rash maculopapular
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Gastrointestinal disorders
Nausea
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Nervous system disorders
Dizziness
|
3.3%
2/61 • Number of events 2 • 2 years and 11 months
|
|
General disorders
Pain
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Skin and subcutaneous tissue disorders
Night sweats
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
General disorders
Fatigue
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
|
Musculoskeletal and connective tissue disorders
Arthralgia
|
1.6%
1/61 • Number of events 1 • 2 years and 11 months
|
Additional Information
Dr. Nisha Unni
University of Texas Southwestern Medical Center
Phone: 214-648-4180
Email: [email protected]
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place