Neoplasms

Skin and Connective Tissue Diseases

All Conditions

Breast Neoplasms

Breast Diseases

Skin Diseases

Antineoplastic Agents

All Drugs and Chemicals

Trastuzumab

Paclitaxel

Carboplatin

Pembrolizumab

Docetaxel

Albumin-Bound Paclitaxel

Standard drug: Neoadjuvant treatment : Weekly paclitaxel + carboplatin + pembrolizumab (TCP) followed by EC90 \*4 pembrolizumab

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite

Standard drug:

EC100 followed by docetaxel + trastuzumab or EC100 followed by paclitaxel + trastuzumab Docetaxel + carboplatin + trastuzumab \*6 folowed by trastuzumab alone

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite

Standard drug: EC100 paclitaxel or EC100 docetaxel

Procedure: supplementary biopsy at inclusion + centralized blood samples and questionnaires at evaluation visite

biopsy will be performed for multi-omicanalysis at inclusion before initiation of treatment

Biopsy

Centralized blood samples will be performed at inclusion + evaluation visits

Blood samples

Food inquiry + food-frequency questionnaire + physical activity questionnaire will be performed at inclusion

Questionnaires

Jean Sebastien FRENEL, MD

Marine TIGREAT

Anne PASTSOURIS, MD

Jean Sébastien FRENEL, MD

Breast cancer (BC) is the most common cancer in women in France with nearly 58,500 new cases and 12,150 deaths estimated in 2018 .

Two major achievements have been made in the last five years for breast cancer patients. The first is therapeutic with the approval of immune checkpoint inhibitors in advanced and early triple-negative BC (TNBC) and the impressive efficacy of new antibody-drug conjugated in all BC subtypes. The second is conceptual with the generalization of adaptive therapeutic strategies guided by pathological responses after neoadjuvant therapy in early TNBC, HER2+, HR+ and BRCA mutated breast cancer. This new paradigm in the treatment of cancer patients completely redefined prognostic factors that were previously established with conventional approaches Pathological response remains a major prognostic factor especially for TNBC and HER2 early breast cancer. However, this parameter is evaluated at the end of neoadjuvant treatment and for patients with residual disease, the prognosis remains poor despite some adaptative strategies.

Our project is to integrate massive and heterogeneous data concerning the disease (clinical and biological data, imaging and histological results (with multi-omics data)) and patient's environment, personal and familial history. These data are multiple and have dynamic interactions overtime. With the help of mathematical units with biological competences and scientific collaborations, our project is to improve the prediction of treatment response, based on clinical and molecular heterogeneous big data investigation.

The main objective of this project is to set up a clinicobiological database prospectively by collecting prospective clinical, biological, pathological and multi-omic data from 300 Patients with early BC treated at the ICO in order to define an algorithm of individual decision for the prediction of the response to this treatment.

Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients

The primary endpoint is the predictive yield of complete pathological response (pCR) after the neoaduvant treatment

The primary endpoint is the predictive yield of Event Free Survial up to 5 years

The primary endpoint is the predictive yield of overall Survival up to 5 years

Institut Cancerologie de l'Ouest

Respiratory Tract (Lung and Bronchial) Diseases

Lung Neoplasms

Respiratory Tract Neoplasms

Thoracic Neoplasms

Lung Diseases

Respiratory Tract Diseases

Vaccines

At each disease progression, patient will have specific interventions :

* Metastasis biopsy
* Biomarkers blood, urine and microbiota samples
* Patient Reported Outcome (PRO)

Metastasis biopsy will be performed for multi-omic analysis Biological/Vaccine: Biomarkers blood, urine and microbiota samples Biomarkers blood, urine and microbiota samples for multi-omic analysis Behavioral: Patient Reported Outcome (PRO) Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.

Metastasis biopsy

JUDITH RAIMBOURG, MD,PHD

RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and biopathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

This prospective study will be conducted on first line metastatic lung cancer patients. Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or lung tumor if local recurrence, usual treatment protocols are often guided by the following groups:

* For group 1: SCLC (small cell lung cancer)

  * Carbo or cisplatin + etoposide chemotherapy associated to atezolizumab or durvalumab
* For group 2: NSCLC (no small cell lung cancer) without oncogenic addiction:

  * Adenocarcinoma, NOS, sarcomatoïd carcinoma or large cell carcinoma with PDL1 expression level ≥ 50%: Carbo/cisplatin + pemetrexed + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab - Adenocarcinoma, NOS, sarcomatoïde carcinoma or large cell carcinoma with PDL1 expression level \< 50%: Carbo/cisplatin + pemetrexed + pembrolizumab.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt +/- bevacizumab

- Squamous cell carcinoma with PDL1 ≥ 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt - Squamous cell carcinoma with PDL1 \< 50%: Carboplatin + paclitaxel + pembrolizumab or pembrolizumab alone.

In case of contra indication of pembrolizumab, treatment will be based on doublet of chemotherapy with platinum salt

• For group 3: NSCLC NSCLC (no small cell lung cancerwith oncogenic addiction (KRAS G12c/BRAFV600E/NTRK/ROS1/ALK/EGFR/RET/NTRK/HER2):

* For which TKI is indicated: TKI as long as possible
* If TKI is not indicated: doublet of chemotherapy with platinum salt +/- pembrolizumab or pembrolizumab alone for PDL1 ≥ 50% or doublet of chemotherapy +/- bevacizumab

Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.

Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 3 months according to patient group. Clinical, biological, pathological, epidemiological, socio-economic and multiomic data will be collected throughout the study duration. These massive data will be used to create new algorithms in order to help clinicians to predict treatment response

Clinico-biological Data Collection Study of Metastatic Lung Cancer

Prediction in Silico of Therapeutic Response in a Prospective Cohort Study of Metastatic Lung Cancer Patients

Overall Survival is defined by the delay between the date of inclusion and the date of death or last follow-up assessment

The response to treatment will be assessed using local radiological review according to RECIST 1.1 criteria

Progression Free survival is defined by the delay between the first dose of a treatment sequence and the date of documented disease progression or death

Symptoms and General Pathology

Disease Progression

Metastasis biopsy will be performed for multi-omic analysis

Biomarkers blood, urine and microbiota samples for multi-omic analysis

Biomarkers blood, urine and microbiota samples

Patient Reported Outcome (PRO) will be collected throughout the study duration to assess quality of life, anxiety, depression distress, physical activity and food habits.

Patient Reported Outcome (PRO)

Mario CAMPONE, MD, PhD

Anne PATSOURIS, MD

Caroline FONSEGRIVE, MD

Elouen BOUGHALEM, MD

Frederic BIGOT, MD

Julie VANBOCKSTAEL, MD

Paule AUGEREAU, MD

Patrick SOULIE, MD

Sophie ABADIE LACOURTOISIE, MD

Dominique BERTON-RIGAUD, MD

Emmanuelle BOURBOULOUX, MD

Marie ROBERT, MD

Carole GOURMELON, MD

Pauline DU RUSQUEC, MD

RATIONALE : Currently, the mechanisms associated with the response or resistance to treatment are poorly understood and are multifactorial. These mechanisms involve clinical and biological factors associated with the host and the tumor and possibly the patient's psycho-social environment.

PURPOSE : This trial will assess the use of a prospective database dedicated to patients with breast cancers that contains clinical data as well as epidemiological, psychological, emotional, social, imaging, biological and bio-pathological data. These data will allow a creation of new modelling algorithms in order to predict response and resistance to treatment.

This prospective study will be conducted on first line metastatic breast cancer patients.

Three phenotypic groups are identified on immunohistochemistry done at inclusion: on metastatic sites or breast tumor if local recurrence, usual treatment protocols are often guided by the following groups:

* Group 1 : Patients HR (Hormon Receptor) + (E (Estrogen Receptor) + and/or PR (Progesterone Receptor) +) and HER2- (Human Epidermal Growth Factor Receptor-2)
* Group 2 : Patients HER2 + with or without HR+
* Group 3 : Patients triple negative (HR- and HER2-) Patients will receive treatments as per standard care according to the patient group.

Standard treatments recommended for treatment first line are:

1. For group 1 : For HR + and HER2- patients :

   * For patients requiring Chemotherapy (visceral crisis), the recommended treatment is : Taxanes based chemotherapy Anthracyclines based chemotherapy
   * For the patients without visceral crisis: the recommended treatment is : Hormonal therapy combined with CDK 4-6 inhibitors (Cyclin-dependent kinase) as recommended in standard care.
2. For group 2 : HER2 + (with or without HR+), the recommended treatment is :

   * Paclitaxel (Taxol) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.
   * Docetaxel (Taxotere) combined with Trastuzumab (Herceptin) and Pertuzumab (Perjeta) as per the institutional standard of care.
3. For group 3 : triple negative (HR- and HER2-) patients, the recommended treatment is :

   * Paclitaxel (Taxol) with or without Bevacizumab (Avastin) as per the institutional standard of care.

Further treatment lines are administered according to standard practice. Biological and histological assessments are performed on specific metastasis biopsy samples done at baseline and at each progression.

Physical exam, standard laboratory tests, imaging (CT (computerized tomography) scan, PET-CT (Positron emission tomography-computed tomography) and bone scan (for patients with bone metastasis) will be performed every 2 to 6 months according to patient group.

Clinical, biological, pathological, epidemiological, socio-economic and multi-omic data will be collected throughout the study duration.

These massive data will be used to create new algorithms in order to help clinicians to predict treatment response.

monocentric, open, prospective database with specific biopsy and blod collections done (biocollection)

Clinico-biological Data Collection Study of Metastatic Breast Cancer

Prediction in Silico of Overall Survival in a Pilot Prospective Cohort Study of Metastatic Breast Cancer Patients

search of algorithms combining multiple data (clinical, biological, imaging) in breast cancer management

Overall Survival is the delay between the date of inclusion and the date of death or last follow-up assessment if censored.

Progression Free survival is the delay between the first dose of a treatment sequence and the date of documented disease progression or death

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Prediction in Silico of Pathological Response in a Prospective Cohort Study of Early Breast Cancer Patients	NCT05981326	Breast Cancer	Biopsy Blood samples Questionnaires	18 Years -	Institut Cancerologie de l'Ouest
Clinico-biological Data Collection Study of Metastatic Lung Cancer	NCT04944030	Lung Cancer	Metastasis biop...	18 Years -	Institut Cancerologie de l'Ouest
Clinico-biological Data Collection Study of Metastatic Breast Cancer	NCT03958136	Breast Cancer	Metastasis biop... Biomarkers bloo... Patient Reporte...	18 Years -	Institut Cancerologie de l'Ouest
Clinico-biological Data Collection Study of Metastatic Lung Cancer	NCT04944030	Lung Cancer	Metastasis biop...	18 Years -	Institut Cancerologie de l'Ouest
Clinico-biological Data Collection Study of Metastatic Breast Cancer	NCT03958136	Breast Cancer	Metastasis biop... Biomarkers bloo... Patient Reporte...	18 Years -	Institut Cancerologie de l'Ouest

Spots Global Cancer Trial Database for multi omic analysis