Phase 2 N=44 Diagnostic

18F-FLT-PET in Breast Cancer (MK-0000-139)

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT01015131 ↗

Enrolled (actual)

Serious AEs

18.2%

Results posted

Dec 2012

Primary outcome: Primary: Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy. — 2.79; 1.78; 1.00 SUV

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: 18F-FLT-PET/CT Imaging (Radiation)
Age: Adult, Older Adult · 35+ yrs
Sex: Female
Sponsor: Merck Sharp & Dohme LLC
Primary completion: May 2011

Outcome Measures

Outcome	Result	p-value
PRIMARY Change From Baseline in 18F-FLT-PET Mean Standardized Uptake Value (SUVmean) After the First Cycle of Standard of Care (SOC) Neo-adjuvant Chemotherapy.	2.79; 1.78; 1.00	—
PRIMARY Change From Baseline in 18F-FLT-PET Maximum Standardized Uptake Value (SUVmax) After the First Cycle of SOC Neo-adjuvant Chemotherapy.	5.76; 3.52; 2.24	—
PRIMARY Change From Baseline in Ki-67 Labeling Index After the First Cycle of SOC Neo-adjuvant Chemotherapy.	57.89; 43.81; 10.53	—
PRIMARY Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy.	0.53	—
PRIMARY Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 Labeling Index and Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy.	0.46	—
SECONDARY Change From Baseline in Proliferation Signature Score (PSS) After the First Cycle of SOC Neo-adjuvant Chemotherapy.	2.34; 2.20; 0.15	<0.01 sig
SECONDARY Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.	22.74; 6.14; 16.59	—
SECONDARY Spearman's Rank Correlation Coefficient Between Change From Baseline in PSS After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.	0.20	—
SECONDARY Spearman's Rank Correlation Coefficient Between Change From Baseline in Ki-67 LI After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.	0.13	—
SECONDARY Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmax After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.	0.22	—
SECONDARY Spearman's Rank Correlation Coefficient Between Change From Baseline in SUVmean After the First Cycle of SOC Neo-adjuvant Chemotherapy, and Change From Baseline in Tumor Volume at the End of SOC Neo-adjuvant Chemotherapy.	0.20	—

Summary

This study correlated changes from baseline in Ki-67, an immunohistochemical marker of cell proliferation, with changes from baseline in tumor uptake of 3'-deoxy-3'[18F]-fluorothymidine (18F-FLT) following the first cycle of treatment with standard of care neo-adjuvant therapy in participants with breast cancer.

Eligibility Criteria

Inclusion Criteria

Has newly-diagnosed stage IIB/IIIA/IIIB locally advanced breast cancer
Is eligible for pre-operative (neo-adjuvant) chemotherapy

Exclusion Criteria

Has a contraindication to magnetic resonance imaging (MRI)
Any condition that would limit ability to undergo MRI or PET scans
Is a nursing mother
Has moderate to end-stage renal disease and is not on dialysis or has renal failure on chronic dialysis

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT01015131). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.