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Stage IIB Breast CancerPhase 2NCT00572728

Phase II Study of Fluorine-18 3'-Deoxy-3'-Fluorothymidine (F-18-FLT) in Invasive Breast Cancer

A Phase 2 study testing CT, 18F-FLT and PET in people with Stage IIB Breast Cancer and Stage IIIA Breast Cancer, run by National Cancer Institute (NCI) at 27 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 18 years and older
What is being tested?
CT, 18F-FLT and PET
Type of treatment
Surgery or procedure
Could I receive a placebo?
No, everyone receives an active treatment
How many people
90 participants
Where
27 sitesUnited States
Study dates
Dec 2008to Oct 2014
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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 =< 2 (Karnofsky >= 60%)
Show all 14Show fewer
  • 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]) =< 2.5 times the institutional upper limit of normal
  • Creatinine within normal institutional limits OR creatinine clearance >= 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

Who cannot join

  • 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

Trial locations and contacts

27 sites in 1 country.

27 sites in 1 country

United States27 sites

  • University of North Carolina

    Chapel Hill, North Carolina, 27599

  • Medical University of South Carolina

    Charleston, South Carolina, 29425

  • Morton Plant Hospital

    Clearwater, Florida, 33756

  • Barbara Ann Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Wayne State University/Karmanos Cancer Institute

    Detroit, Michigan, 48201

  • Morton Plant Mease

    Dunedin, Florida, 34695

  • Penn State Milton S Hershey Medical Center

    Hershey, Pennsylvania, 17033-0850

  • Excel Diagnostics

    Houston, Texas, 77042

  • Westchase Oncology Center

    Houston, Texas, 77042

  • University of Arkansas for Medical Sciences

    Little Rock, Arkansas, 72205

  • USC / Norris Comprehensive Cancer Center

    Los Angeles, California, 90033

  • University of Wisconsin Hospital and Clinics

    Madison, Wisconsin, 53792

  • Ochsner Medical Center Jefferson

    New Orleans, Louisiana, 70121

  • Mount Sinai Medical Center

    New York, New York, 10029

  • Mount Sinai School of Medicine

    New York, New York, 10029

  • American College of Radiology Imaging Network

    Philadelphia, Pennsylvania, 19103

  • Hospital of The University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • University of Pennsylvania School of Medicine

    Philadelphia, Pennsylvania, 19104

  • Thomas Jefferson University Hospital

    Philadelphia, Pennsylvania, 19107

  • Fox Chase Cancer Center

    Philadelphia, Pennsylvania, 19111

  • Virginia Commonwealth University/Massey Cancer Center

    Richmond, Virginia, 23298

  • Scottsdale Medical Imaging Limited

    Scottsdale, Arizona, 85251

  • University of Washington Medical Center

    Seattle, Washington, 98195

  • Siteman Cancer Center at Washington University

    St Louis, Missouri, 63110

  • Washington University School of Medicine

    St Louis, Missouri, 63110

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157

  • Radiology Consultants Inc

    Youngstown, Ohio, 44512

Other trials in United States

About this study

Official title: 3'-Deoxy-3'-18F Fluorothymidine PET/CT in Predicting Response To Chemotherapy Before Surgery in Patients With Locally Advanced Breast Cancer

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.

Read the detailed description

PRIMARY OBJECTIVES:

  1. To correlate the percentage change in standardized uptake value at 60 minutes (SUV60) between baseline (FLT-1) and early-therapy (FLT-2) with pathologic complete response to neoadjuvant chemotherapy of the primary tumor in patients with locally advanced breast cancer.

SECONDARY OBJECTIVES:

  1. To demonstrate correlation between FLT-1 and post-therapy (FLT-3) uptake parameters and tumor proliferation markers in locally advanced breast cancer.

II. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response of the primary tumor and residual cancer burden (RCB).

III. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and non-response of the primary tumor (stable or progressive disease) to therapy.

IV. To evaluate the relationship between FLT-1, FLT-2 and FLT-3 uptake parameters and pathologic complete response to neoadjuvant chemotherapy in patients with regional disease in the lymph nodes in patients with locally advanced breast cancer.

  1. To compare the changes of FLT-2 and FLT-3 uptake parameters to changes in tumor sizes from other serial imaging modalities such as mammograms, magnetic resonance imaging (MRI), and ultrasound.

VI. To compare the changes of FLT-2 and FLT-3 uptake parameters to metabolic changes from [18F] fludeoxyglucose (FDG)-PET, as available.

VII. To continue to monitor for potential safety issues and define any physiologic effects associated with 18F FLT administration.

OUTLINE:

Patients undergo 18F-FLT PET/CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.

Being tested
CT, 18F-FLT, PET
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CTProcedure or surgery

    Also called CAT, CAT Scan, Computed Tomography, Computerized Axial Tomography

    Undergo 18F-FLT PET/CT

  • 18F-FLTDrug

    Also called Fluorothymidine F-18, 3'-deoxy-3'-(18F) fluorothymidine, 3'-deoxy-3'-[18F]fluorothymidine, fluorothymidine F 18

    Undergo 18F-FLT PET/CT

  • PETProcedure or surgery

    Also called Medical Imaging, Positron Emission Tomography, Positron Emission Tomography, PET SCAN, Positron Emission Tomography Scan

    Undergo 18F-FLT PET/CT

Study groups in NCT00572728
Study groupRoleWhat they receive
Diagnostic (18F-FLT)ExperimentalPatients undergo 18F-FLT PET /CT at baseline (prior to chemotherapy, FLT-1), early therapy (5-10 days after the initiation of the first course of chemotherapy, FLT-2), and post therapy (within 3 weeks prior to surgery, FLT-3). Patients undergo standard surgical resection of residual tumor following completion of neoadjuvant chemotherapy.
Receives: Procedure: CT; Drug: 18F-FLT; Procedure: PET

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. %Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response

    The primary statistical evaluation will be based on the percent change in FLT SUV60 between baseline (pre-therapy, FLT-1) and the early-therapy imaging (5-10 days after chemotherapy, FLT-2) studies

    Measured: Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)

Secondary outcomes (8)

  1. Correlation Between SUVmax and Ki-67 LI at FLT1(Baseline PET)

    For the purposes of reporting, SUVmax @ FLT1 will be considered the outcome. the correlation is measured between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT1 .

    Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells.

    Measured: Baseline (FLT-1)

  2. Correlation Between SUVmax and Ki-67 LI at FLT3 (Post-NAC)

    For the purposes of reporting, SUVmax @ FLT-3 will be considered the outcome. correlation between the fraction of Ki-67-positive tumor cells (the Ki-67 labeling index) and SUVmax at FLT-3 Ki-67 labeling index (LI) was calculated as the number of Ki-67 positive tumor cells per one thousand tumor cells.

    Measured: Post-NAC (FLT3)

  3. SUVmax at FLT-1 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III

    While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the Standardized Uptake Values the measurement of interest and report those values herein.

    Mean Standard Uptake Values (max) at Baseline (FLT-1) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III

    Measured: Baseline (FLT-1)

  4. SUVmax at FLT-2 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III

    While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the uptake values the measurement of interest and report those values herein.

    Mean Standard Uptake Values (max) after one cycle of NAC (FLT2) were compared for Participants with Residual Cancer Burden (RCB) 0/I vs RCB II/III

    Measured: early treatment (FLT2)

  5. SUVmax at FLT-3 Comparison Between Residual Cancer Burden (RCB) 0/I and RCB II/III

    The Standard Uptake Values (max) after completion of NAC (FLT-3) were compared for Participants with Residual Cancer Burden 0/I vs Residual Cancer Burden of II/III While normally RCB (or other final determination) would be considered the outcome, since this is a predictive question, we will consider the mean of the uptake values the measurement of interest and report those values herein.

    Measured: post-NAC (FLT-3)

  6. Change in Uptake Between FLT1 and FLT3 to Predict Pathologic Complete Response (pCR) of the Primary Tumor

    To evaluate the relationship between the change in uptake between FLT1 and FLT3 and pathologic complete response, an ROC curve will be estimated and the area under the curve (AUC), along with its 90% confidence interval, will be determined. For the purposes of reporting, we will consider the percent change in uptake between FLT1 and FLT3 to be the outcome.

    Reported values in the Outcome Measure table represent Change in uptake between FLT1 and FLT3, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT3 and pathological complete response was assessed by using ROC analysis. The Area Under the ROC Curve is reported in the Statistical Analysis section

    Measured: Baseline (FLT-1) and post-NAC (FLT-3)

  7. %Change SUVmax From FLT1-FLT2 to Predict Lymph Node Status at Surgery

    Reported values in the Outcome Measure table represent %Change in uptake between FLT1 and FLT2, i.e., percentage change of SUVmax. The relationship between the change in uptake between FLT1 and FLT2 and lymph node (LN) status. For the purposes of reporting, the % Change in SUV will be considered the outcome.

    Measured: Baseline (FLT-1) and Early Therapy (FLT-2)

  8. %Change SUVmax From FLT1-FLT3 to Predict Lymph Node Status at Surgery

    %change in SUVmax from FLT1-FLT3 will be compared by lymph node status at surgery For the purposes of reporting, %change in SUVmax from FLT1-FLT3 will be consider the outcome.

    Measured: Baseline (FLT-1) and post-NAC (FLT-3)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted13 Dec 2007 (estimated)
  2. Study startDec 2008
  3. Primary completionSep 2014
  4. Study completionOct 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Diagnosis
Allocation
Not applicable
Intervention model
Single group
Masking
None (open label)
Enrolment
90 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00572728
Sponsor's protocol ID
NCI-2009-00266
Other IDs
NCI-2009-00266, ACRIN 6688, 8029, N01CM27165
Status last verified
Dec 2016
First submitted
11 Dec 2007
Last updated
30 Dec 2016
Data monitoring committee
Yes

Publications

  • Kostakoglu L, Duan F, Idowu MO, Jolles PR, Bear HD, Muzi M, Cormack J, Muzi JP, Pryma DA, Specht JM, Hovanessian-Larsen L, Miliziano J, Mallett S, Shields AF, Mankoff DA; ACRIN 668 Investigative Team. A Phase II Study of 3'-Deoxy-3'-18F-Fluorothymidine PET in the Assessment of Early Response of Breast Cancer to Neoadjuvant Chemotherapy: Results from ACRIN 6688. J Nucl Med. 2015 Nov;56(11):1681-9. doi: 10.2967/jnumed.115.160663. Epub 2015 Sep 10.

    PubMed 26359256

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CT, 18F-FLT and PET in people with Stage IIB Breast Cancer and Stage IIIA Breast Cancer, run by National Cancer Institute (NCI) at 27 sites in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 14 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 30 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 27 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 20 Jan 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

%Change in FLT Uptake Between the Baseline (Pre-therapy) and the Early-therapy Imaging Studies to Predict Pathological Complete Response (time frame: Baseline (FLT-1) to early therapy (5-10 days after chemotherapy, FLT-2)). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00572728, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Dec 2016.

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