Metastatic Breast Cancer Clinical Trial
— ESMERALDAOfficial title:
A PHASE II TRIAL EVALUATING THE COMBINATION OF ERIBULIN (HALAVEN®) + BEVACIZUMAB (AVASTIN®) AS A FIRST LINE TREATMENT IN PATIENTS WITH METASTATIC HER2- BREAST CANCER
The efficacy of eribulin is now well known in metastatic breast cancer. Furthermore, a phase
III combine study ( chemo + bev)in metastatic first line shown a gain in PFS with no extra
toxicities.
It could be interesting to explore the combination of bev + eribulin in first line
metastatic breast cancer.
| Status | Completed |
| Enrollment | 61 |
| Est. completion date | March 2016 |
| Est. primary completion date | August 2014 |
| Accepts healthy volunteers | No |
| Gender | Female |
| Age group | 18 Years and older |
| Eligibility |
Inclusion Criteria: - Age > 18 ans - Patient with metastatic mammary adenocarcinoma - Hormone receptors ER and PR positive or negative for HER 2 negative Exclusion Criteria: - Prior chemotherapy for metastatic disease - Previous treatment with eribulin or bevacizumab - Presence of symptomatic brain metastases or meningeal |
Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Country | Name | City | State |
|---|---|---|---|
| France | Centre Paul Papin | Angers | |
| France | Centre Hospitalier d'Auxerre | Auxerre | |
| France | Institut Ste Catherine | Avignon | |
| France | Clinique Tivoli | Bordeaux | |
| France | Hôpital Fleyriat | Bourg-en-Bresse | |
| France | Hôpital Morvan - Centre Hospitalier Universitaire | Brest | |
| France | centre Francois baclesse | Caen | |
| France | Centre Hospitalier William Morey | Chalon sur Saône | |
| France | Hôpital Privé Sainte-Marie | Chalon sur Saône | |
| France | Centre d'Oncologie et de Radiothérapie | Dijon | |
| France | Centre Hospitalier la Dracénie | Draguignan | |
| France | Centre Hospitalier Intercommunal | Fréjus | |
| France | Hôpital Privé Drôme Ardèche - Clinique Pasteur | Guilherand-Granges | |
| France | Centre Léon Bérard | Lyon | |
| France | Clinique de la Sauvegarde | Lyon | |
| France | Hôpital Privé Clairval | Marseille | |
| France | Hôpital de Mont-de-Marsan | Mont-de-Marsan | |
| France | Centre d'oncologie de Gentilly | Nancy | |
| France | Centre Catherine de Sienne | Nantes | |
| France | Centre Antoine Lacassagne | Nice | |
| France | Centre Hospitalier Régional | Orléans | |
| France | Groupe Hospitalier Saint-Joseph | Paris | |
| France | Hôpital Cochin | Paris | |
| France | Institut Curie - Hopital Claudius Régaud | Paris | |
| France | Centre Catalan d'Oncologie | Perpignan | |
| France | Centre Hospitalier Lyon-sud | Pierre-Bénite | |
| France | Centre Hospitalier de la Région d'Annecy | Pringy | |
| France | Clinique Courlancy | Reims | |
| France | Institut Jean Godinot | Reims | |
| France | Centre Henri Becquerel | Rouen | |
| France | Clinique Armoricaine de Radiologie | Saint Brieuc | |
| France | Anne-Claire Hardy-Bessard, MD | Saint-Brieuc | |
| France | Centre Hospitalier Privé de Saint-Grégoire | Saint-Grégoire | |
| France | GHPSO - Site Senlis | Senlis | |
| France | Centre de Radiothérapie - Clinique Sainte-Anne | Strasbourg | |
| France | Centre Hospitalier de Thonon-les-Bains | Thonon-Les-Bains | |
| France | Clinique Pasteur | Toulouse | |
| France | CHU Bretonneau | Tours | |
| France | Centre Hospitalier de Valence | Valence | |
| France | Centre Hospitalier Bretagne Atlantique | Vannes |
| Lead Sponsor | Collaborator |
|---|---|
| ARCAGY/ GINECO GROUP |
France,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Number of patient with non progressive disease | The principal endpoint is to determine the disease control rate (or rate of non-progression) at one year in patients with metastatic breast cancer treated in the first line setting by a combination of eribulin/bevacizumab. In this open-label trial, the sample size is calculated based on Simon's two-stage design, used to test whether the disease control rate at one year will be at least 50%, a clinically promising rate, versus a rate of 33%, a rate that is not clinically promising. Considering a type I risk (alpha) error of 5%, with 54 patients, this study has an 80% power to detect a disease control rate at one year of 50%. |
12 months | No |
| Secondary | Toxicity based on the CTCAE v4.03 criteria | 12 months | Yes |
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Withdrawn |
NCT04872608 -
A Study of Letrozole, Palbociclib, and Onapristone ER in People With Metastatic Breast Cancer
|
Phase 1 | |
| Terminated |
NCT02202746 -
A Study to Assess the Safety and Efficacy of the VEGFR-FGFR-PDGFR Inhibitor, Lucitanib, Given to Patients With Metastatic Breast Cancer
|
Phase 2 | |
| Completed |
NCT02506556 -
Phosphatidylinositol 3-kinase (PI3K) Alpha iNhibition In Advanced Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05534438 -
A Study on Adding Precisely Targeted Radiation Therapy (Stereotactic Body Radiation Therapy) to the Usual Treatment Approach (Drug Therapy) in People With Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT03368729 -
Niraparib in Combination With Trastuzumab in Metastatic HER2+ Breast Cancer
|
Phase 1/Phase 2 | |
| Completed |
NCT04103853 -
Safety, Tolerability, and Pharmacokinetics of Proxalutamide Therapy in Women With Metastatic Breast Cancer
|
Phase 1 | |
| Terminated |
NCT01847599 -
Educational Intervention to Adherence of Patients Treated by Capecitabine +/- Lapatinib
|
N/A | |
| Active, not recruiting |
NCT03147287 -
Palbociclib After CDK and Endocrine Therapy (PACE)
|
Phase 2 | |
| Not yet recruiting |
NCT06062498 -
Elacestrant vs Elacestrant Plus a CDK4/6 Inhibitor in Patients With ERpositive/HER2-negative Advanced or Metastatic Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05383196 -
Onvansertib + Paclitaxel In TNBC
|
Phase 1/Phase 2 | |
| Recruiting |
NCT04095390 -
A Phase Ⅱ Trial of Pyrotinib Combination With CDK4/6 Inhibitor SHR6390 in Patients Prior Trastuzumab-treated Advanced HER2-Positive Breast Cancer
|
Phase 2 | |
| Active, not recruiting |
NCT04432454 -
Evaluation of Lasofoxifene Combined With Abemaciclib in Advanced or Metastatic ER+/HER2- Breast Cancer With an ESR1 Mutation
|
Phase 2 | |
| Recruiting |
NCT03323346 -
Phase II Trial of Disulfiram With Copper in Metastatic Breast Cancer
|
Phase 2 | |
| Recruiting |
NCT05744375 -
Trastuzumab Deruxtecan in First-line HER2-positive Locally Advanced/MBC Patients Resistant to Trastuzumab+Pertuzumab
|
Phase 2 | |
| Completed |
NCT02924883 -
A Study to Evaluate the Efficacy and Safety of Trastuzumab Emtansine in Combination With Atezolizumab or Atezolizumab-Placebo in Participants With Human Epidermal Growth Factor-2 (HER2) Positive Locally Advanced or Metastatic Breast Cancer (BC) Who Received Prior Trastuzumab and Taxane Based Therapy
|
Phase 2 | |
| Completed |
NCT01942135 -
Palbociclib (PD-0332991) Combined With Fulvestrant In Hormone Receptor+ HER2-Negative Metastatic Breast Cancer After Endocrine Failure (PALOMA-3)
|
Phase 3 | |
| Completed |
NCT01881230 -
Evaluate Risk/Benefit of Nab Paclitaxel in Combination With Gemcitabine and Carboplatin Compared to Gemcitabine and Carboplatin in Triple Negative Metastatic Breast Cancer (or Metastatic Triple Negative Breast Cancer)
|
Phase 2/Phase 3 | |
| Active, not recruiting |
NCT04448886 -
Sacituzumab Govitecan +/- Pembrolizumab In HR+ / HER2 - MBC
|
Phase 2 | |
| Completed |
NCT01401959 -
Trial of Eribulin in Patients Who Do Not Achieve Pathologic Complete Response (pCR) Following Neoadjuvant Chemotherapy
|
Phase 2 | |
| Terminated |
NCT04720664 -
Oral SM-88 in Patients With Metastatic HR+/HER2- Breast Cancer
|
Phase 2 |