Breast CancerNCT00534274
Positron Emission Tomography Using 3'-Deoxy-3'-(18F) Fluorothymidine in Treating Women With Locally Advanced Cancer in One Breast Who Are Receiving Chemotherapy
A study testing 3'-deoxy-3'-[18F]fluorothymidine in people with Breast Cancer, run by UNICANCER at 24 sites in France.
Trial summary
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer. Read more about this study
- Who is it for?
- Ages 18 to 65 years, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- 3'-deoxy-3'-[18F]fluorothymidine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 97 participants
- Where
- 24 sitesFrance
- Study dates
- Nov 2006to Sep 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
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 to 65 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed unilateral breast cancer
- T2 or T3, any N, M0
- Unifocal by mammography and ultrasound
- Negative for c-erbB2 by immunohistochemistry (IHC)
- Planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined
- Measurable disease by ultrasound
Show all 14Show fewer
- Hormone receptor status not specified
- ECOG performance status 0-1
- Female
- Menopausal status not specified
- Hematologic, hepatic, and renal function normal
- Not pregnant or nursing
- Fertile patients must use effective contraception
- See Disease Characteristics
Who cannot join
- Bilateral disease
- Multifocal tumor
- Invasive grade I lobular cancer
- Metastatic disease
- Stage ≥ T4 disease
- Cutaneous invasion, major adherence, or inflammatory disease
Show all 14Show fewer
- Tumor overexpressing c-erbB2 by IHC (HER 2+++)
- Suspected clinical or radiological lesion (examined or not)
- PATIENT CHARACTERISTICS:
- Alcohol dependency or prior reaction to ethanol injection
- Impossible to receive study therapy due to geographical, social, or psychological reasons
- Prisoners or patients under supervision
- PRIOR CONCURRENT THERAPY:
- Participation in another concurrent therapeutic study with an experimental drug
Trial locations and contacts
24 sites in 1 country.
24 sites in 1 country
France24 sites
Centre Hospitalier Regional et Universitaire d'Angers
Angers, 49033
Centre Paul Papin
Angers, 49036
Centre Hospitalier de la Cote Basque
Bayonne, 64100
Hopital Saint Andre
Bordeaux, 33075
CHU de Bordeaux - Hopital Pellegrin
Bordeaux, 33076
Polyclinique Bordeaux Nord Aquitaine
Bordeaux, 33300
CHU Hopital A. Morvan
Brest, 29609
Centre Regional Francois Baclesse
Caen, 14076
Centre Jean Perrin
Clermont-Ferrand, 63011
Centre de Lutte Contre le Cancer Georges-Francois Leclerc
Dijon, 21079
Centre Oscar Lambret
Lille, 59020
Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
Marseille, 13273
CHU de la Timone
Marseille, 13385
Centre Regional de Lutte Contre le Cancer - Centre Val d'Aurelle
Montpellier, 34298
CHR Hotel Dieu
Nantes, 44093
Centre Regional Rene Gauducheau
Nantes-Saint Herblain, 44805
Centre Antoine Lacassagne
Nice, 06189
Hopital de l'Archet CHU de Nice
Nice, F-06202
Hopital Saint-Louis
Paris, 75475
Hopital Tenon
Paris, 75970
CHU Poitiers
Poitiers, 86021
Centre Henri Becquerel
Rouen, 76038
Centre Rene Huguenin
Saint-Cloud, 92211
Centre Hospitalier Universitaire Bretonneau de Tours
Tours, 37044
About this study
Official title: Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.
PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.
Read the detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of positron emission tomography (PET) utilizing 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) to correctly identify response to neoadjuvant chemotherapy in women with locally advanced unilateral breast cancer.
- Correlate PET-^18F-FLT results with histological response.
Secondary
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT after the first course of chemotherapy with complete response after treatment completion.
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT with histologic response in biopsies obtained after 1 course of chemotherapy.
- Determine if the initial intensity of tumor uptake is a predictive value of response to chemotherapy.
- Determine if initial intensity of tumor uptake of ^18F-FLT varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Determine if the tumor uptake of ^18F-FLT during therapy varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Evaluate the role of TK1 on the kinetics of ^18 F-FLT.
- Analyze serum.
- Research biomarkers of genomics, transcription, and proteomics.
- Evaluate the toxicity of ^18F-FLT.
OUTLINE: This is a multicenter study.
Patients receive 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) IV and undergo positron emission tomography (PET) before the first and second courses of neoadjuvant chemotherapy. Patients receiving bisequential chemotherapy undergo ^18F-FLT-PET before the change in drugs (usually the fourth or fifth course). All patients undergo a final ^18F-FLT-PET after the last chemotherapy course but before surgery.
After completion of study therapy, patients are followed for 1 month.
- Conditions
- Breast Cancer
- Being tested
- 3'-deoxy-3'-[18F]fluorothymidine
- Keywords
- stage II breast cancer, stage IIIA breast cancer
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
3'-deoxy-3'-[18F]fluorothymidineOther
| Study group | Role | What they receive |
|---|---|---|
| TEP FLT | Experimental | Not described Receives: Other: 3'-deoxy-3'-[18F]fluorothymidine |
What is being measured
The primary outcome is the main question the study is designed to answer.
Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria
Measured: Post surgery
Secondary outcomes (7)
Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV)
Measured: Post surgery
Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV
Measured: Post surgery
Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV
Measured: post surgery
Histologic parameters: type, grade, mitotic index, CCIS , and microbiopsy embols after first course of chemotherapy (and on microbiopsy before therapeutic change of sequence in patients receiving bisequential chemotherapy)
Measured: post surgery
Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin)
Measured: Post-surgery
Rate of thymidine kinase 1 (TK1)
Measured: Post surgery
Toxicity by CTC-AE v. 3.0
Measured: Post surgery
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2007 (estimated)
- Study startNov 2006
- Primary completionApr 2012
- Study completionSep 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by UNICANCERThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
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 N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 97 participants (actual)
Sponsor and investigators
- Lead sponsor
- UNICANCER
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Olivier Couturier, MD, Study chair, Centre Hospitalier Regional et Universitaire d'Angers
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00534274
- Sponsor's protocol ID
- FLT01 - UC-0140/0505
- Other IDs
- FRE-FNCLCC-FLT-01/0505, EU-20754, 2005-005166-37, 2005
- Status last verified
- Dec 2014
- First submitted
- 20 Sep 2007
- Last updated
- 16 Dec 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Dec 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Positron Emission Tomography With 3'-Deoxy-3'-[18F] Fluoro-thymidine ([18F]-FLT) for the Evaluation of Response to Neoadjuvant Chemotherapy for Cancers of the Breast
- ClinicalTrials.gov ID
- NCT00534274
- Acronym / sponsor ID
- FLT01 - UC-0140/0505
- Conditions
- Breast Cancer
- Keywords
- stage II breast cancer, stage IIIA breast cancer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 97 participants (actual)
- Lead sponsor
- UNICANCERUniversity, hospital or other
- Study start
- Nov 2006
- Primary completion
- Apr 2012 (actual)
- Study completion
- Sep 2013 (actual)
- First posted
- 24 Sep 2007 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
RATIONALE: Diagnostic procedures, such as positron emission tomography (PET) using 3'-deoxy-3'-(18F) fluorothymidine, may be effective in assessing the response to chemotherapy before surgery in treating locally advanced breast cancer.
PURPOSE: This clinical trial is studying how well positron emission tomography using 3'-deoxy-3'-(18F) fluorothymidine works in treating women with locally advanced cancer in one breast who are receiving chemotherapy.
Detailed description
OBJECTIVES:
Primary
- Evaluate the efficacy of positron emission tomography (PET) utilizing 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) to correctly identify response to neoadjuvant chemotherapy in women with locally advanced unilateral breast cancer.
- Correlate PET-^18F-FLT results with histological response.
Secondary
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT after the first course of chemotherapy with complete response after treatment completion.
- Evaluate the correlation of early changes in tumor uptake of ^18F-FLT with histologic response in biopsies obtained after 1 course of chemotherapy.
- Determine if the initial intensity of tumor uptake is a predictive value of response to chemotherapy.
- Determine if initial intensity of tumor uptake of ^18F-FLT varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Determine if the tumor uptake of ^18F-FLT during therapy varies according to histologic type of tumor, indices of proliferation, and tumor cellularity before therapy.
- Evaluate the role of TK1 on the kinetics of ^18 F-FLT.
- Analyze serum.
- Research biomarkers of genomics, transcription, and proteomics.
- Evaluate the toxicity of ^18F-FLT.
OUTLINE: This is a multicenter study.
Patients receive 3'-deoxy-3'-(18F) fluorothymidine (^18F-FLT) IV and undergo positron emission tomography (PET) before the first and second courses of neoadjuvant chemotherapy. Patients receiving bisequential chemotherapy undergo ^18F-FLT-PET before the change in drugs (usually the fourth or fifth course). All patients undergo a final ^18F-FLT-PET after the last chemotherapy course but before surgery.
After completion of study therapy, patients are followed for 1 month.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| TEP FLT | Experimental | Other: 3'-deoxy-3'-[18F]fluorothymidine |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (14 listed)
- Histologically confirmed unilateral breast cancer
- Negative for c-erbB2 by immunohistochemistry (IHC)
- Planning neoadjuvant chemotherapy comprising anthracyclines and/or taxanes, alone or combined
- Measurable disease by ultrasound
- Hormone receptor status not specified
Key exclusion criteria (14 listed)
- Bilateral disease
- Multifocal tumor
- Invasive grade I lobular cancer
- Metastatic disease
- Stage ≥ T4 disease
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 3'-deoxy-3'-[18F]fluorothymidine | Other | TEP FLT |
Primary outcome
Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria
Time frame: Post surgery
7 secondary outcomes
Intensity of tumor uptake of 18F-FLT by standardized uptake value (SUV)
Time frame: Post surgery
Variation of tumoral uptake as seen by positron emission tomography (PET) before, during, and after therapy as determined visually and by SUV
Time frame: Post surgery
Intensity of the tumoral uptake of 18F-FLT on initial exam visually and by SUV
Time frame: post surgery
Histologic parameters: type, grade, mitotic index, CCIS , and microbiopsy embols after first course of chemotherapy (and on microbiopsy before therapeutic change of sequence in patients receiving bisequential chemotherapy)
Time frame: post surgery
Immunohistochemical evaluation (estrogen and progesterone receptors, c-erbB2, Ki-67, e-cadherin)
Time frame: Post-surgery
Rate of thymidine kinase 1 (TK1)
Time frame: Post surgery
Toxicity by CTC-AE v. 3.0
Time frame: Post surgery
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Dec 2014.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Olivier Couturier, MD study chair
Centre Hospitalier Regional et Universitaire d'Angers
24 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 3'-deoxy-3'-[18F]fluorothymidine in people with Breast Cancer, run by UNICANCER at 24 sites in France.
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 14 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 16 Dec 2014. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 24 sites in France. 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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Intensity of tumor uptake of 3'-deoxy-3'-(18F) fluorothymidine (18F-FLT) determined visually and correlated with histological or surgical response according to Sataloff criteria (time frame: Post surgery). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Dec 2014.