Breast NeoplasmsNCT02600442
Assessment of Breast Cancer Response to Neoadjuvant Anthracycline-based Chemotherapy by FDG-PET and Molecular Markers
An observational study of Breast Neoplasms and Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site in France.
Trial summary
A correlation between early changes in the tumor maximum standardized uptake value (SUVmax) on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological response after 6 to 8 cycles has been demonstrated in several independent small series of patients. Read more about this study
- Who is it for?
- Any age
- Conditions the study is for
- Breast Neoplasms, Breast Cancer
- What is being tested?
- non interventional study
- How many people
- 168 participants
- Where
- 1 siteFrance
- Study dates
- Jul 2013to Dec 2020
- Phase
- Observational
- 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 Any age
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Study population: Stage II-III Breast cancer
Who may be able to join
- Women aged ≥ 18 years
- Newly diagnosed invasive breast cancer
- Stage-II or stage-III
- Neoadjuvant anthracycline-based chemotherapy
- Primary breast biopsy must be available
- Non metastatic, M0
- No prior systemic therapy for the presFrance: Direction Generale de la Sante ent tumor
- Willingness and ability to comply with scheduled visits, treatment plan, laboratory tests, and other trial procedures
Who cannot join
- Metastatic breast cancer
- Uncontrolled diabetes
- Limited breast cancer immediately accessible to conservative surgery and not candidate for neoadjuvant chemotherapy
- Previous homolateral breast cancer and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
- Any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 12 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
- Diagnosis of any previous malignancy within the last 5 years, except for adequately treated basal cell carcinoma, or squamous cell skin carcinoma, or in situ cervical carcinoma
Trial locations and contacts
1 site in 1 country.
France1 site, 1 recruiting
- Recruiting
Hopital siant-Louis
Paris, Paris, 75010
David Groheux, MD-PHD, 630603009 ext. +33, david.groheux@aphp.fr
matthieu resche-rigon, MD-PHD, 142499742 ext. +33, matthieu.resche-rigon@univ-paris-diderot.fr
About this study
Official title: Assessment of Breast Cancer Response to Neoadjuvant Anthracycline-based Chemotherapy by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) and Molecular Markers
A correlation between early changes in the tumor maximum standardized uptake value (SUVmax) on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological response after 6 to 8 cycles has been demonstrated in several independent small series of patients.
Breast tumor proliferation status has previously been demonstrated to be a good predictive factor of response to chemotherapy. The best method for assessing proliferation status is unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay for comparing the proliferation status between tumors. However major variations in analytical procedure and interpretation limited its clinical value. Taking into account the prognosis and predictive value of proliferation gene as a common "signature" in breast cancer transcriptome analysis, quantitative assessment of mRNA expression of genes involved in proliferation has been developed by the investigators team and others. The evaluation of these parameters is quantitative and reliable and can be standardized for a clinical use.
The main objective of the investigators study is to early predict pathological response to anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based on FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).
- Conditions
- Breast Neoplasms, Breast Cancer
- Being tested
- non interventional study
- Keywords
- Neoadjuvant Therapy, Chemotherapy, Positron-Emission Tomography, PET-CT, FDG, Fluorodeoxyglucose, Diagnosis, Prognosis, Pathological complete response, molecular biology, proliferation genes
- Medical subject headings
- Breast Neoplasms, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non interventional studyOther
| Study group | Role | What they receive |
|---|---|---|
| main and unique cohort | Not described Receives: Other: non interventional study |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pathological complete response to anthracycline-based neoadjuvant chemotherapy
- To analyze separately clinical, pathological and molecular biomarkers currently used to identify molecular breast cancer subgroups of the primary tumor that, coupled with the metabolic response, could improve early pathological prediction.
- To analyze separately the biological, molecular, and genetic biomarkers from the study that, coupled with the metabolic response, could improve early pathological prediction.
- To analyze separately high throughput analysis of molecular biomarkers of the primary tumor that, coupled with the metabolic response, could improve early pathological prediction.
Measured: Within the first 30 days after surgery
Secondary outcomes (8)
Overall Survival
Measured: 5 years
Overall Survival
Measured: 3 years
Event Free survival
To determine the 5 years Event free survival (EFS) rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis.
Measured: 5 years
Event Free survival
To determine the 3 years Event free survival (EFS) rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis.
Measured: 3 years
Breast Cancer specific survival
To determine the 5 years Breast Cancer Specific survival rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis.
Measured: 5 years
Breast Cancer specific survival
To determine the 3 years Breast Cancer Specific survival rates in breast cancer patients according to PET response, biological markers and biomarkers identified with molecular high throughput analysis.
Measured: 3 years
Pathological partial response to anthracycline-based neoadjuvant chemotherapy
- To analyze separately clinical, pathological and molecular biomarkers currently used to identify molecular breast cancer subgroups of the primary tumor that, coupled with the metabolic response, could improve early pathological prediction.
- To analyze separately the biological, molecular, and genetic biomarkers from the study that, coupled with the metabolic response, could improve early pathological prediction.
- To analyze separately high throughput analysis of molecular biomarkers of the primary tumor that, coupled with the metabolic response, could improve early pathological prediction.
Measured: Within the first 30 days after surgery
Delta SUV
To evaluate the correlation between baseline molecular status of proliferation and FDG uptake measured at baseline, after 2 cycles of NAC and the change (delta SUV).
Measured: Within the first 20 days after the second cycle of chemotherapy
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2015 (estimated)
- Study startJul 2013
- Primary completionDec 2016 (estimated)
- Study completionDec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast NeoplasmsStudies of the same condition, open and under way.
- More trials run by Assistance Publique - Hôpitaux de ParisThe 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
- Observational
- Observational model
- Cohort
- Enrolment
- 168 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assistance Publique - Hôpitaux de Paris
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ingrid Veron, Study chair, DRCDPatricia de Cremoux, MD-PhD, Principal investigator, APHP, IUH, University Paris Diderot, Paris 7, SPCDavid Groheux, MD-PhD, Principal investigator, APHP, IUH, University Paris Diderot, Paris 7, SPC
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02600442
- Sponsor's protocol ID
- 2013/27NICB
- Status last verified
- Sep 2016
- First submitted
- 5 Nov 2015
- Last updated
- 29 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Breast Cancer Response to Neoadjuvant Anthracycline-based Chemotherapy by Fluorodeoxyglucose Positron Emission Tomography (FDG-PET) and Molecular Markers
- ClinicalTrials.gov ID
- NCT02600442
- Acronym / sponsor ID
- 2013/27NICB
- Conditions
- Breast Neoplasms, Breast Cancer
- Keywords
- Neoadjuvant Therapy, Chemotherapy, Positron-Emission Tomography, PET-CT, FDG, Fluorodeoxyglucose, Diagnosis, Prognosis
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 168 participants (estimated)
- Lead sponsor
- Assistance Publique - Hôpitaux de ParisUniversity, hospital or other
- Study start
- Jul 2013
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2020 (estimated)
- First posted
- 9 Nov 2015 (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.
A correlation between early changes in the tumor maximum standardized uptake value (SUVmax) on FDG-PET after one or two cycles of neoadjuvant chemotherapy (NAC) and the pathological response after 6 to 8 cycles has been demonstrated in several independent small series of patients.
Breast tumor proliferation status has previously been demonstrated to be a good predictive factor of response to chemotherapy. The best method for assessing proliferation status is unclear. Proportion of cells staining for nuclear Ki67 antigen is the most widely used assay for comparing the proliferation status between tumors. However major variations in analytical procedure and interpretation limited its clinical value. Taking into account the prognosis and predictive value of proliferation gene as a common "signature" in breast cancer transcriptome analysis, quantitative assessment of mRNA expression of genes involved in proliferation has been developed by the investigators team and others. The evaluation of these parameters is quantitative and reliable and can be standardized for a clinical use.
The main objective of the investigators study is to early predict pathological response to anthracycline-based neoadjuvant chemotherapy (NAC) using a combination of parameters based on FDG-PET imaging performed at baseline and after 2 cycles, and molecular markers of proliferation measured on pre-treatment biopsy (Ki67 protein level by immunohistochemistry and Ki67 mRNA level and the mRNA (messenger RNA) expression of the most pertinent genes of the Genomic Grade Index (GGI) component by RT (reverse transcriptase) - qPCR).
Study design
- Observational model
- Cohort
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| main and unique cohort | – | Other: non interventional study |
Who may qualify
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- Stage II-III Breast cancer
Key inclusion criteria (8 listed)
- Women aged ≥ 18 years
- Newly diagnosed invasive breast cancer
- Stage-II or stage-III
- Neoadjuvant anthracycline-based chemotherapy
- Primary breast biopsy must be available
Key exclusion criteria (6 listed)
- Metastatic breast cancer
- Uncontrolled diabetes
- Limited breast cancer immediately accessible to conservative surgery and not candidate for neoadjuvant chemotherapy
- Previous homolateral breast cancer and/or contralateral breast cancer except if treated by surgery +/- radiation therapy alone without any systemic treatment
- Any surgery (not including minor procedures such as lymph node biopsy, primary tumor core biopsy, fine needle aspiration) within 12 weeks of start of study treatment; or not fully recovered from any side effects of previous procedures.
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 |
|---|---|---|
| non interventional study | Other | main and unique cohort |
Primary outcome
Pathological complete response to anthracycline-based neoadjuvant chemotherapy
Time frame: Within the first 30 days after surgery
* To analyze separately clinical, pathological and molecular biomarkers currently used to identify molecular breast cancer subgroups of the primary tumor that, coupled with the metabolic response, could improve early pathological prediction. * To analyze separately the biological, molecular, and genetic biomarkers from the study that, coupled with the metabolic response, could improve early pathological prediction. * To analyze separately high throughput analysis of molecular biomarkers of the primary tumor that, coupled with the metabolic response, could improve early pathological prediction.
8 secondary outcomes
Overall Survival
Time frame: 5 years
Overall Survival
Time frame: 3 years
Event Free survival
Time frame: 5 years
Event Free survival
Time frame: 3 years
Breast Cancer specific survival
Time frame: 5 years
Breast Cancer specific survival
Time frame: 3 years
Pathological partial response to anthracycline-based neoadjuvant chemotherapy
Time frame: Within the first 30 days after surgery
Delta SUV
Time frame: Within the first 20 days after the second cycle of chemotherapy
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Sep 2016.
Related trials for Breast Neoplasms
Active, not recruiting
Streamlined Geriatric and Oncological Evaluation Based On IC Technology
Breast Cancer, Comorbidities and Coexisting Conditions
RecruitingPhase 2
Gene Signatures to Guide HR+MBC Therapy in a Diverse Cohort
Invasive Mammary Carcinoma, Metastatic Breast Cancer
Not yet recruitingObservational study
Comparison of Reliability, Time Cost, and Participant Comfort of Lymphedema Assessments in Upper Extremity
Lymphedema, Upper Extremity Lymphedema
RecruitingPhase 3
A Study of Camrelizumab Plus Chemotherapy in Combination With or Without Famitinib as Neoadjuvant Therapy in Participants With Triple Negative Breast Cancer (BCTOP-T-N01)
TNBC - Triple-Negative Breast Cancer
RecruitingPhase 3
Testing Whether Hormone Therapy With Ribociclib is as Effective as Chemotherapy Followed by Hormone Therapy With Ribociclib for the Treatment of High Anatomic Stage Breast Cancer With Low Recurrence Risk, The RxFINE-Low Trial
Anatomic Stage II Breast Cancer AJCC v8, Anatomic Stage IIIA Breast Cancer AJCC v8
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.
Ingrid Veron study chair
DRCD
Patricia de Cremoux, MD-PhD principal investigator
APHP, IUH, University Paris Diderot, Paris 7, SPC
David Groheux, MD-PhD principal investigator
APHP, IUH, University Paris Diderot, Paris 7, SPC
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Neoplasms and Breast Cancer, run by Assistance Publique - Hôpitaux de Paris at 1 site 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 8 inclusion and 6 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: status not confirmed, as of the sponsor's last update on 29 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Patricia de Cremoux, MD-PhD (142499388 ext. +33, patricia.de-cremoux@aphp.fr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pathological complete response to anthracycline-based neoadjuvant chemotherapy (time frame: Within the first 30 days after 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 29 Sep 2016.