Phase 2
Completed N=90
Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer
Stage IIB Breast Cancer · Stage IIIA Breast Cancer · Stage IIIB Breast Cancer · Stage IIIC Breast Cancer
Source: ClinicalTrials.gov NCT00572728 ↗
Enrolled (actual)
90
Serious AEs
0.0%
Results posted
Jan 2016
Primary outcomePrimary: %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response — 38.78 percentage change of SUVmax — p=0.046
Summary
This phase II trial studies how well 3'-deoxy-3'-18F fluorothymidine (18F-FLT) positron emission tomography (PET)/computed tomography (CT) works in predicting response in patients receiving chemotherapy and undergoing surgery for breast cancer that has spread from where it started to nearby tissue or lymph nodes. Diagnostic procedures, such as 18F-FLT PET/CT, may help in learning how well chemotherapy works to kill breast cancer cells before surgery and help doctors plan the best treatment.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response |
38.78 | 0.046 sig |
| SECONDARY Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET) |
5.71 | 0.002 sig |
| SECONDARY Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC) |
1.88 | <0.0001 sig |
| SECONDARY SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III |
5.9; 6.2; 5.8 | 0.66 |
| SECONDARY SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III |
3.3; 3.5; 3.2 | 0.86 |
| SECONDARY SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III |
1.8; 0.7; 2.4 | 0.010 sig |
| SECONDARY Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor |
38.8; 52.7; 35.8 | <0.001 sig |
| SECONDARY %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery |
44.9; 47.7; 43.8; 42.6 | 0.86 |
| SECONDARY %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery |
71.4; 65.2; 77.6; 69.5 | 0.67 |
Eligibility Criteria
Inclusion Criteria
- Pathologically confirmed breast cancer, determined to be a candidate for primary systemic (neoadjuvant) therapy and for surgical resection of residual primary tumor following completion of neoadjuvant therapy
- Locally advanced breast cancer, not stage IV, and with a tumor size >= 2 cm (as measured on imaging or estimated by physical exam)
- No obvious contraindications for primary chemotherapy
- Residual tumor planned to be removed surgically following completion of neoadjuvant therapy
- Able to lie still for 1.5 hours for PET scanning
- Eastern Cooperative Oncology Group (ECOG) performance status = = 60%)
- Leukocytes >= 3,000/ul
- Absolute neutrophil count >= 1,500/ul
- Platelets >= 100,000/ul
- Total bilirubin within normal institutional limits
- Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase [SGOT])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase [SGPT]) = = 30 mL/min/1.73 m^2 for patients with creatinine levels above institutional normal
- If female, postmenopausal for a minimum of one year, OR surgically sterile, OR not pregnant, confirmed by institutional standard of care (SOC) pregnancy test, and willing to use adequate contraception (hormonal or barrier method of birth control; abstinence) for the duration of study participation
- Able to understand and willing to sign a written informed consent document and a Health Insurance Portability and Accountability Act (HIPAA) authorization in accordance with institutional guidelines
Exclusion Criteria
- Previous treatment (chemotherapy, radiation, or surgery) to involved breast; including hormone therapy
- Uncontrolled intercurrent illness including, but not limited to, ongoing or active infection, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, or psychiatric illness/social situations that would limit compliance with study requirements
- Medically unstable
- Condition requiring anesthesia for PET scanning and/or unable to lie still for 1.5 hours
- History of allergic reactions attributed to compounds of similar chemical or biologic composition to F-18 fluorothymidine
- Pregnant or nursing
- Previous malignancy, other than basal cell or squamous cell carcinoma of the skin or in situ carcinoma of the cervix, from which the patient has been disease free for less than 5 years
- Currently on hormone therapy as the primary systemic neoadjuvant therapy
Data sourced from ClinicalTrials.gov (NCT00572728). 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. Informational only — not medical advice.