Clinical trials: sponsored by UNICANCER
Early Breast Cancer, Premenopausal Breast Cancer
Optimising Adjuvant Chemotherapy Prescription in Young Patients With Hormone-dependent Breast Cancer Using Genomic Tests
Rationale: Around 70 to 80% of breast cancers are so-called "hormone-dependent" (HR+)/HER2-. For more than 50 years, studies have shown that chemotherapy and optimised hormonal treatments (hormone therapy), including a drug…
- Conditions
- Early Breast Cancer, Premenopausal Breast Cancer, HR+/HER2- Breast Cancer
- Trial name
- OPTIMA-YOUNG (NCT07106632)
- Testing
- test-directed treatment: allocated treatment will depend on the PAM50 score result (centrally assessed) : chemo-endocrine therapy or endocrine therapy alone, In the control arm, the treatment will be as standard of care : chemo-endocrine therapy
- Where
- 105 sites in Belgium, France and 5 more
- Volunteers
- 3,380 people
- Sponsor
- UNICANCER
Primary Non-metastatic Breast Cancer, Who Remain Disease-free
Safety Study of Adding Everolimus to Adjuvant Hormone Therapy in Women With High Risk of Relapse, ER+ and HER2- Primary Breast Cancer, Free of Disease After Receiving at Least One Year of Adjuvant Hormone Therapy
A significant number of patients relapse and eventually die, particularly if they were initially diagnosed with large nodes involvement and/or T3/4 diseases.
- Trial name
- NCT01805271
- Testing
- Everolimus
- Where
- 2 sites in France
- Volunteers
- 1,278 people
- Sponsor
- UNICANCER
Hereditary Breast and Ovarian Cancer, Mutation
Investigation of Tumour Spectrum of Germline Mutations in Breast and Ovarian Cancer Genes.
TUMOSPEC is a national family study designed to measure the relative and absolute risk of cancer for carriers of deleterious mutations to these "new" breast cancer (BC) susceptibility genes.
- Trial name
- TUMOSPEC (NCT03246841)
- Testing
- Genetic testing
- Where
- 2 sites in France
- Volunteers
- 7,274 people, healthy volunteers welcome
- Sponsor
- UNICANCER
Locally Advanced or Metastatic Breast Cancer
Antibody-based PET Imaging and Treatment Response in Breast Cancer Treated With an Antibody-drug Conjugate.
OASIS-ImmunoPET is a monocentric pilot study evaluating antibody imaging to predict response to antibody-drug conjugate (ADC), an innovative cancer targeted therapy, and potentially replace tumor biopsy.
- Trial name
- OASISImmunoPET (NCT07294430)
- Testing
- Immuno-PET
- Volunteers
- 30 people
- Sponsor
- UNICANCER
Triple-negative Breast Cancer
Pembrolizumab and Chemotherapy Treatment or no Treatment Guided by the Level of TILs in Resected Early-stage TNBC
Triple-negative breast cancer (TNBC) is a group of tumors that occurs mainly in young, premenopausal women and accounts for 10-20% of breast cancers.
- Trial name
- ETNA (NCT06078384)
- Testing
- Pembrolizumab 25 mg/ml, Paclitaxel injection
- Where
- 44 sites in France, Spain
- Volunteers
- 354 people
- Sponsor
- UNICANCER
ER-positive and HER2-negative Metastatic or Locally Advanced Breast Cancer, a Germline or Somatic BRCA Mutation, or a Deleterious Alteration of Other Genes Involved in Homologous Recombination Repair (HRR) or in MSI Status
Durvalumab, With Olaparib and Fulvestrant in Advanced ER+, HER2- Breast Cancer Patients.
This study evaluates the efficacy of the combination of olaparib, durvalumab, and fulvestrant for the treatment of patients with ER-positive, HER2-negative, locally advanced or metastatic breast cancer with BRCA gene alterations…
- Trial name
- DOLAF (NCT04053322)
- Testing
- Durvalumab, Olaparib, Fulvestrant
- Where
- 2 sites in France
- Volunteers
- 172 people
- Sponsor
- UNICANCER
Gastric Adenocarcinoma, Esophagus Adenocarcinoma
Oxaliplatin ± Nivolumab in Combination With Trifluridine/Tipiracil or 5-fluorouracile in Frail Patients With Advanced, Recurrent or Metastatic Gastric, Oesophageal or Gastroesophageal Junction Cancer
Oxaliplatin ± nivolumab in combination with trifluridine/tipiracil or 5-fluorouracile (5-FU) in frail patients with advanced, recurrent or metastatic gastric, oesophageal or gastroesophageal junction cancer.
- Conditions
- Gastric Adenocarcinoma, Esophagus Adenocarcinoma, Gastroesophageal Junction Adenocarcinoma
- Trial name
- LOGICAN (NCT05476796)
- Testing
- Trifluridine/Tipiracil, Oxaliplatin, FOLFOX regimen
- Where
- 28 sites in France
- Volunteers
- 118 people
- Sponsor
- UNICANCER
Locally Advanced Rectal Adenocarcinoma
Study Evaluating Two Treatment Strategies for Rectal Cancer in Patients ≥75 Years Old
The primary objective of the NACRE-2 trial is to assess whether the addition of chemotherapy after short-course radiotherapy is more effective than short-course radiotherapy alone in elderly patients with locally advanced rectal…
- Trial name
- NACRE-2 (NCT07118800)
- Testing
- FOLFOX4s, Short Course Radiotherapy
- Volunteers
- 160 people
- Sponsor
- UNICANCER
Breast Cancers, Triple Negative Breast Cancer (TNBC)
Personalizing the Use of Pembrolizumab for Patients Who Have a Strong Response in Early Triple Negative Breast Cancer
OPT-PEMBRO trial is a pragmatic, multicentre, international, prospective, non-inferiority, two-arms, randomised (1:1), open-label, Phase III clinical study.
- Trial name
- OPT-PEMBRO (NCT06606730)
- Testing
- Pembrolizumab, Deescalation
- Where
- 2 sites in Belgium, France
- Volunteers
- 2,454 people
- Sponsor
- UNICANCER
Breast Cancer
Evaluation of an Online Intervention to Educate Women at High Risk of Breast Cancer on How to Help Reduce Their Risk.
Breast cancer remains the most common cancer among women and a major cause of death despite advances in screening and treatment. Current screening programs are not personalized and are experiencing declining participation.
- Trial name
- MyPREV (NCT07120087)
- Testing
- Intervention
- Where
- 3 sites in France, Italy
- Volunteers
- 1,508 people, healthy volunteers welcome
- Sponsor
- UNICANCER
Cancer Metastatic
Endocrine Therapy With Abemaciclib or Chemotherapy as Initial Metastatic Treatment in ER+/HER2- Breast Cancer
AMBRE is a phase III study comparing two standard treatments as initial metastatic treatment in ER+/HER2- breast cancer (BC) patients with visceral metastasis and high burden disease: Chemotherapy and combination of endocrine…
- Trial name
- AMBRE (NCT04158362)
- Testing
- Paclitaxel injection, Capecitabine tablets, Letrozole 2.5mg
- Where
- 2 sites in France
- Volunteers
- 180 people
- Sponsor
- UNICANCER
Colorectal Cancer
Personalizing Chemotherapy Selection After Surgery for Patients With Stage III Colorectal Cancer Using a Blood Test
CIRCULATE-III is an international, multicenter, open-label, randomized phase III trial designed to use ctDNA as a selection criterion for intensification or de-escalation of adjuvant chemotherapy.
- Trial name
- CIRCULATEIII (NCT07340567)
- Testing
- Capecitabine, Oxaliplatin, Folfirinox
- Where
- 5 sites in France, Sweden
- Volunteers
- 2,450 people
- Sponsor
- UNICANCER
Breast Screening
My Personalized Breast Screening
MyPeBS is an international randomized, open-label, multicentric, study assessing the effectiveness of a risk-based breast cancer screening strategy (using clinical risk scores and polymorphisms) compared to standard screening…
- Trial name
- MyPeBS (NCT03672331)
- Testing
- Mammogram, Ultrasound, MRI
- Where
- 6 sites in Belgium, France and 4 more
- Volunteers
- 53,142 people, healthy volunteers welcome
- Sponsor
- UNICANCER
Ewing Sarcomas, Chondrosarcomas
A Phase II Study Evaluating Efficacy and Safety of Regorafenib in Patients With Metastatic Bone Sarcomas
INDICATION: Metastatic bone sarcomas: conventional high grade osteosarcoma, Ewing sarcoma of bone, intermediate or high-grade chondrosarcomas and chordomas and either bone or soft tissue metastatic CIC-rearranged sarcomas
- Conditions
- Ewing Sarcomas, Chondrosarcomas, Osteosarcomas, Chondroma
- Trial name
- REGOBONE (NCT02389244)
- Testing
- Regorafenib
- Where
- 19 sites in France
- Volunteers
- 163 people
- Sponsor
- UNICANCER
Metastatic Breast Cancer, HER2-positive Breast Cancer
Decreasing Treatment for Metastatic HER2-Positive Breast Cancer With Undectable Cancer Levels in Blood Tests.
Heroes is a multicentre, national, non-randomized, open-label, phase 2 study. The goal of this clinical trial is to evaluate the feasibility of therapeutic de-escalation in HER2-positive metastatic breast cancer with disease…
- Trial name
- HEROES (NCT06450314)
- Testing
- Discontinuation of the anti-HER2 maintenance therapy, Monitoring with signatera test
- Where
- France
- Volunteers
- 170 people
- Sponsor
- UNICANCER
Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancers
SPECT-CT Guided ELEctive Contralateral Neck Treatment in Lateralized Oropharyngeal Cancer
Oropharyngeal cancer (OPC) is the most common type of head and neck cancer. The current standard treatment for this cancer is radiotherapy (RT) of the tumour and lymph nodes of both sides of the neck, combined with concurrent…
- Conditions
- Oropharyngeal Squamous Cell Carcinoma, Oropharyngeal Cancers, Oropharyngeal Carcinoma, Head and Neck
- Trial name
- SELECT-FR (NCT07241273)
- Testing
- Lymphatic mapping with SPECT-CT, Bilateral neck radiotherapy, Ipsilateral neck radiotherapy & SPECT-CT guided contralateral neck radiotherapy
- Where
- 12 sites in France
- Volunteers
- 128 people
- Sponsor
- UNICANCER
Cutaneous Melanoma, Stage III, Mucosal Melanoma
Neo-adjuvant Immunotherapy in Patients With Localized Melanoma
The success of anti-PD-1 and anti-CTLA-4 therapies has initiated a paradigm shift in oncology, with drugs now targeting the immune system rather than cancer cells to stimulate the antitumor immune response.
- Trial name
- NEOREM-NEO-1 (NCT07230613)
- Testing
- Ipilimumab (YervoyTM, 50 mg/10 mL solution), Nivolumab (OpdivoTM, 40 mg/4mL solution)
- Where
- 6 sites in France
- Volunteers
- 50 people
- Sponsor
- UNICANCER
Metastatic Invasive Breast Cancer
Rising ctDNA to Tailor Endocrine Therapy Switch in Patients With ER+/HER2- Metastatic Breast Cancer.
Rationale: In patients with metastatic breast cancer, fragments of tumor DNA called "circulating tumor DNA" or "ctDNA" can be detected in the blood.
- Trial name
- TAILORswitch (NCT07717450)
- Testing
- Tumor assessment, Completion of Quality-of-life questionnaires, ECG
- Volunteers
- 370 people
- Sponsor
- UNICANCER
Breast Cancer
Deescalation of Endocrine Therapy Duration in Women With HR+ HER2- Breast Cancer at Very Low Risk
Hormone therapy is recommended for five years in all patients with hormone receptor-positive breast cancer, but there is no consensus on its duration in low-risk tumours and especially in postmenopausal women.
- Trial name
- LESS (NCT05297617)
- Testing
- Anti-aromatase inhibitor
- Where
- 2 sites in France
- Volunteers
- 696 people
- Sponsor
- UNICANCER
Triple Negative Breast Cancer, Metastatic Breast Cancer
Safety and Efficacy Analysis of an Antibody Associated With a Chemotherapy for Patients With a Triple Negative Metastatic Breast Cancer
ISIdE is an European, multicentric study that aims to assess the efficacy of Sacituzumab Govitecan (SG) in locally advanced or metastatic triple-negative breast cancer where the disease has progressed despite chemotherapy or…
- Trial name
- ISIdE (NCT05552001)
- Testing
- Sacituzumab govitecan
- Where
- France
- Volunteers
- 96 people
- Sponsor
- UNICANCER