Assessment of Breast Cancer Response to Neoadjuvant Anthracycline-based Chemotherapy by FDG-PET and Molecular Markers

NCT02600442 | Unknown

• 1 other identifier: 2013/27NICB
• Study Type: observational
• Target: 168
• Locations: 1 country
• Sites: 1

Brief 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. 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

Keywords

Neoadjuvant Therapy; Chemotherapy; Positron-Emission Tomography; PET-CT; FDG; Fluorodeoxyglucose; Diagnosis; Prognosis; Pathological complete response; molecular biology; proliferation genes

Outcome Measures

Primary Outcomes (1)

• 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.

  Within the first 30 days after surgery

Secondary Outcomes (8)

• Overall Survival

  5 years

• Overall Survival

  3 years

• Event Free survival

  5 years

• Event Free survival

  3 years

• Breast Cancer specific survival

  5 years

Study Arms (1)

main and unique cohort

Other: non interventional study

Interventions

non interventional study OTHER

main and unique cohort

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Stage II-III Breast cancer

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Assistance Publique - Hôpitaux de Paris: lead

Study Sites (1)

Hopital siant-Louis

Paris, Paris, 75010, France

RECRUITING

Biospecimen

Retention: SAMPLES WITHOUT DNA

somatic molecular analyses

MeSH Terms

Conditions

Breast Neoplasms; Disease

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Ingrid Veron

  DRCD

  STUDY CHAIR

• Patricia de Cremoux, MD-PhD

  APHP, IUH, University Paris Diderot, Paris 7, SPC

  PRINCIPAL INVESTIGATOR

• David Groheux, MD-PhD

  APHP, IUH, University Paris Diderot, Paris 7, SPC

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Patricia de Cremoux, MD-PhD

CONTACT

142499388; patricia.de-cremoux@aphp.fr

David Groheux, MD-PhD

CONTACT

142499411; david.groheux@aphp.fr

Study Design

• Study Type: observational
• Observational Model: COHORT
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 5, 2015
• First Posted: November 9, 2015
• Study Start: July 1, 2013
• Primary Completion: December 1, 2016
• Study Completion: December 1, 2020
• Last Updated: September 29, 2016

Record last verified: 2016-09

Locations

FR (1)