Triple Negative Breast Cancer: Identification Pilot Study of Predictive Transcriptome Profiles of Early Tumor Drug Resistance Observed in 18F-Fluorodeoxyglucose (FDG) PET (TRANSTEP)
Primary Purpose
Breast Neoplasms
Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
PET with FDG
Tumor exome analysis
Sponsored by
About this trial
This is an interventional diagnostic trial for Breast Neoplasms
Eligibility Criteria
Inclusion Criteria:
- Women more than 18 years old
- breast cancer recently diagnosis (no prior treatment), histologically proven
- stade II or III in the "International union against cancer"(UICC) classification
- non metastatic patient
- Eastern Cooperative Oncology Group (ECOG) 0 or 1
- Negativity of estrogen and progesterone receptor of the tumor (<10%)
- Absence of overexpression of HER2 according to the classification Immunohistochemistry (IHC) - score 0 or 1+
- Patient having read the information note
- written, dated and signed Informed consent
Exclusion Criteria:
- Unresectable breast cancer, bilateral, inflammatory (T4d) or metastatic.
- Unbalanced diabetes during PET scans (glucose more or equal to 9 mmol)
- Small breast cancer indication with first-conserving surgery
- Treated breast cancer history
- Pregnancy or breastfeeding
- Refusal of the patient for trial participation
- Private Person of liberty under supervision or under curators
- Inability to submit to medical follow-up testing for social or psychological reasons
- No affiliation to a social security scheme or medical state aid or the universal medical coverage
- Known allergy or hypersensitivity to 18F-fluorodeoxyglucose
- Patients with known renal impairment (creatinine clearance <60 ml / min / 1.73m2) or a known hepatic failure
- Patients with a strict regime without salt (sodium levels may be higher than 1 mmol in a dose of 18 FDG).
Sites / Locations
- CGFL
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
FDG PET + exome analysis before treatment and after
Arm Description
Participants will performed one PET with FDG an tumor exome analysis before treatment is started.After 6 cycles of chemotherapy a second PET with FDG and a second tumor exome analysis will be performed
Outcomes
Primary Outcome Measures
Variation of mutational profile
Variation of the mutational profile of the tumor will be assess by exome analysis
Secondary Outcome Measures
Full Information
NCT ID
NCT02850302
First Posted
July 25, 2016
Last Updated
August 8, 2018
Sponsor
Centre Georges Francois Leclerc
1. Study Identification
Unique Protocol Identification Number
NCT02850302
Brief Title
Triple Negative Breast Cancer: Identification Pilot Study of Predictive Transcriptome Profiles of Early Tumor Drug Resistance Observed in 18F-Fluorodeoxyglucose (FDG) PET
Acronym
TRANSTEP
Study Type
Interventional
2. Study Status
Record Verification Date
August 2018
Overall Recruitment Status
Completed
Study Start Date
November 8, 2016 (Actual)
Primary Completion Date
November 8, 2016 (Actual)
Study Completion Date
October 31, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Georges Francois Leclerc
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Breast cancer is a major public health problem. In France, it is the leading cause of cancer death in women. According to the National Cancer Institute (INCA), approximately 49,000 new cases were diagnosed in 2012 in France.
It is an heterogeneous disease, comprising a plurality of entities whose clinical behavior, biological and prognosis differ. Amongst these entities, the breast cancer triple negative (TN) is defined by the absence of expression of estrogen receptor and progesterone and the absence of overexpression of HER2 oncoprotein. It represents about 15% of breast cancers and occurs more frequently in young women. This is a very proliferative tumor phenotype with metastatic potential. Because of its genomic heterogeneity and lack of recurrent identified molecular target, no targeted therapy has today shown benefit in terms of survival compared to conventional cytotoxic chemotherapy, which partly explains the very poor prognosis of this tumor phenotype. The positron emission tomography (PET) with 18Fluoro-deoxy-glucose (FDG) is a molecular imaging test that can identify from the first or second neoadjuvant chemotherapy treatment non-responder patients to treatment with low probability of pathologic complete response (pCR) after neoadjuvant chemotherapy. For this two FDG-PET examinations should be performed; a) a pretreatment PET b) a control PET after one or two treatments. The objective of this pilot, single-center, prospective study is a preliminary identification of recurrent genomic alterations among triple-negative tumors with early chemoresistance, identified by PET in the first cycle of neoadjuvant therapy.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Breast Neoplasms
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
23 (Actual)
8. Arms, Groups, and Interventions
Arm Title
FDG PET + exome analysis before treatment and after
Arm Type
Other
Arm Description
Participants will performed one PET with FDG an tumor exome analysis before treatment is started.After 6 cycles of chemotherapy a second PET with FDG and a second tumor exome analysis will be performed
Intervention Type
Other
Intervention Name(s)
PET with FDG
Intervention Description
A PET with FDG will be performed before the treatment is started and after 6 cycles of chemotherapy.
Intervention Type
Other
Intervention Name(s)
Tumor exome analysis
Intervention Description
A biopsy of the tumor will be performed before the treatment is started and after 6 cycles of chemotherapy. Tumor exome analysis will be performed before treatment is started and after 6 cycles of chemotherapy.
Primary Outcome Measure Information:
Title
Variation of mutational profile
Description
Variation of the mutational profile of the tumor will be assess by exome analysis
Time Frame
15 days
10. Eligibility
Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Women more than 18 years old
breast cancer recently diagnosis (no prior treatment), histologically proven
stade II or III in the "International union against cancer"(UICC) classification
non metastatic patient
Eastern Cooperative Oncology Group (ECOG) 0 or 1
Negativity of estrogen and progesterone receptor of the tumor (<10%)
Absence of overexpression of HER2 according to the classification Immunohistochemistry (IHC) - score 0 or 1+
Patient having read the information note
written, dated and signed Informed consent
Exclusion Criteria:
Unresectable breast cancer, bilateral, inflammatory (T4d) or metastatic.
Unbalanced diabetes during PET scans (glucose more or equal to 9 mmol)
Small breast cancer indication with first-conserving surgery
Treated breast cancer history
Pregnancy or breastfeeding
Refusal of the patient for trial participation
Private Person of liberty under supervision or under curators
Inability to submit to medical follow-up testing for social or psychological reasons
No affiliation to a social security scheme or medical state aid or the universal medical coverage
Known allergy or hypersensitivity to 18F-fluorodeoxyglucose
Patients with known renal impairment (creatinine clearance <60 ml / min / 1.73m2) or a known hepatic failure
Patients with a strict regime without salt (sodium levels may be higher than 1 mmol in a dose of 18 FDG).
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Pierre Fumoleau, Pr
Organizational Affiliation
Centre Georges François Leclerc
Official's Role
Study Director
Facility Information:
Facility Name
CGFL
City
Dijon
ZIP/Postal Code
21079
Country
France
12. IPD Sharing Statement
Learn more about this trial
Triple Negative Breast Cancer: Identification Pilot Study of Predictive Transcriptome Profiles of Early Tumor Drug Resistance Observed in 18F-Fluorodeoxyglucose (FDG) PET
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