Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.
- Conditions
- Breast Cancer
- Interventions
- Registration Number
- NCT02585388
- Lead Sponsor
- ARCAGY/ GINECO GROUP
- Brief Summary
The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment
- Detailed Description
The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment that would have the theoretical advantage of being well tolerated and more effective than chemotherapy alone even after an anti-aromatase therapy.
Recruitment & Eligibility
- Status
- TERMINATED
- Sex
- Female
- Target Recruitment
- 120
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Age ≥ 50 years.
-
Histologically proven breast cancer.
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Progesterone and /or oestrogene receptors positive.
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HER2 negative on primary tumour.
-
Patient taking hormonotherapy, in progression, already treated by at least one line of anti-aromatase non-steroidal hormonotherapy and by at least on line of chemotherapy.
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Patient having to begin a second or third line of chemotherapy.
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Presence of one or several measurable(s) or assessable(s) metastatic lesion(s).In case of isolated bone lesion (s): need to have a non-irradiated with an osteolytic component for be considered as lesion (s) target (s) and having an elevation of the CA15-3.
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Post menopausal woman.
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ECOG 0, 1 or 2.
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Adequate biological function.
- Neutrophil ≥ 1,5.E9/L
- Platelets ≥ 100.E9/L
- Creatinine clearance ≥ 30 mL/min
- Total bilirubin ≤ 1,5 x the upper limit of normal (ULN)
- Alkaline phosphatase ≤ 2,5 x ULN
- ALT, AST ≤ 1,5 x ULN in the absence of liver metastases or ≤ 3 x ULN if liver metastases.
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Patient with a life expectancy greater than 3 months.
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Signed informed consent before enrollment.
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affiliation to a social security scheme
- Patient with located or single metastatic tumoral relapse, accessible to a surgical treatment.
- Patient having already received more 2 lines of chemotherapy for metastatic or advanced decease
- Patient having already received a treatment by Navelbine®
- Patient requiring an immediate located radiotherapy for analgesic action
- Patient with non-irradiated cerebral or symptomatic metastasis, symptomatic pulmonary carcinomatosis lymphangitis
- Simultaneous administration of another chemotherapy hormonotherapy or anti-tumoral drug
- Patient having already received another treatment ongoing evaluation within the 30 days before the screening visit
- Known positive serology HIV
- Previous cancer within 5 years before the entry in the study, excepted an in situ carcinoma of the cervix or a spino or basal cell carcinoma of the skin or a nonmelanoma skin cancer with an adequate treatment.
- Any serious concomitant pathology and / or uncontrolled could compromise participation in the study (including uncontrolled diabetes, uncontrolled hypertension, severe infection, profound malnutrition, unstable angina or congestive heart failure - class III or IV according to the New York Heart Association - ventricular arrhythmias, progressive coronary artery disease, myocardial infarction within the last six months, chronic liver or kidney disease, a progressive ulceration of the digestive tract above, CNS disorders).
- Disorder of gastrointestinal function (GI) or pathology likely to significantly interfere with the absorption of Navelbine, of Letrozole or Anastrozole (eg. Ulcerative disease, uncontrolled nausea, vomiting, diarrhea, syndrome malabsorption, or resection of the small intestine).
- Known hypersensitivity to letrozole, anastrozole, vinorelbine or other vinco-alkaloids or any other component.
- Patient with fructose intolerance, galactose, a Lapp lactase deficiency or malabsorption of glucose and galactose (rare hereditary disease).
- Patient with a history of poor compliance with medical treatment.
- Patient can not be monitored regularly for family reasons, geographical, social or psychological.
- Patient with altered mental status would not allow him to understand the study or give informed consent .
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Vinorelbine Vinorelbine Vinorelbine (metronomic) alone 3 times per week ( mondays, wednesdays, Fridays or Thursdays, Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity. Vinorelbine+Anastrozole or Letrozole Vinorelbine Vinorelbine metronomic 3 times per week (mondays, wednesdays, Fridays or Thursdays,Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity. And: Letrozole 2,5 mg every day or Anastrozole 1 mg every day. Until progression of disease or toxicity Vinorelbine+Anastrozole or Letrozole Letrozole Vinorelbine metronomic 3 times per week (mondays, wednesdays, Fridays or Thursdays,Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity. And: Letrozole 2,5 mg every day or Anastrozole 1 mg every day. Until progression of disease or toxicity Vinorelbine+Anastrozole or Letrozole Anastrozole Vinorelbine metronomic 3 times per week (mondays, wednesdays, Fridays or Thursdays,Tuesdays, Saturdays) at 50 mg per day, taken orally until progression of disease or toxicity. And: Letrozole 2,5 mg every day or Anastrozole 1 mg every day. Until progression of disease or toxicity
- Primary Outcome Measures
Name Time Method Progression free survival (PFS) up to 6 months Proportion of progression or death
- Secondary Outcome Measures
Name Time Method overall survival up to 2 years the overall survival of patients randomized is defined as the time from randomization and the date of death
Toxicity according to criteria NCI CTAEv4.03 up to 2 years tolerance of the treatment based on AE occurrence according to criteria NCI CTAEv4.03
Evaluation of partial and complete response rate by RECIST 1.1 up to 6 months partial and complete response rate by RECIST 1.1 in each arm
clinical benefit after 24 weeks of treatment up to 24 weeks the clinical benefit is defined by the rate of complete response, by the rate of partial response and by the stability of lesions at 24 weeks according to criteria RECIST 1.1
health-related quality of life up to 2 years health-related quality of life and symptomatic state will be evaluated by filling a questionnaire by patients
duration of response up to 6 months duration of response is defined as the time from randomization and the disease progression
Trial Locations
- Locations (46)
CHU de Grenoble
🇫🇷Grenoble, France
CHD Vendée
🇫🇷La Roche sur Yon, France
Centre Hospitalier Lyon Sud
🇫🇷Pierre-Bénite, France
Centre Hospitalier Annecy-Genevois
🇫🇷Pringy, France
Centre Hospitalier Intercommunal des Alpes du Sud
🇫🇷Gap, France
Hôpital Privé Drôme Ardèche
🇫🇷Guilhérand-Granges, France
Centre Hospitalier Fleyriat
🇫🇷Bourg-en-Bresse, France
CH de la Dracénie
🇫🇷Draguignan, France
Hôpital Privé Drôme Ardèche - Clinique Pasteur
🇫🇷Guilherand-granges, France
CH Layne
🇫🇷Mont de Marsan, France
CHU de Brest
🇫🇷Brest, France
Groupe Hospitalier Mutualiste de Grenoble
🇫🇷Grenoble, France
CH Chartres Hôpital Louis Pasteur
🇫🇷Le Coudray, France
Centre Léon Berard
🇫🇷Lyon, France
Centre Hospitalier de l'Agglomération Montargoise
🇫🇷Amilly, France
ICO Paul Papin
🇫🇷Angers, France
Clinique Pasteur
🇫🇷Brest, France
CHR Orléans
🇫🇷Orléans, France
Centre Hospitalier de Pau
🇫🇷Pau, France
Polyclinique Francheville
🇫🇷Perigueux, France
Institut Jean Godinot
🇫🇷Reims, France
Centre Hospitalier Jean Bernard
🇫🇷Valenciennes, France
Hôpital Privé Jean Mermoz
🇫🇷Lyon, France
Centre Azuréen de Cancérologie
🇫🇷Mougins, France
ICO Gauducheau
🇫🇷St Herblain, France
Institut de Cancérologie Lucien Neuwirth
🇫🇷Saint Priest en Jarez, France
Hôpitaux Universitaires de Strasbourg
🇫🇷Strasbourg, France
Institut de Cancérologie de Lorraine
🇫🇷Vandoeuvre Les Nancy, France
Centre Hospitalier de Romans sur Isère
🇫🇷Romans sur Isère, France
Centre Hospitalier Le Mans
🇫🇷Le Mans, France
Oracle
🇫🇷Nancy, France
Hôpitaux du Léman
🇫🇷Thonon-Les-Bains, France
Centre Hospitalier de Soissons
🇫🇷Soissons, France
Polyclinique Côte Basque Sud
🇫🇷St Jean de Luz, France
Institut Sainte-Catherine
🇫🇷Avignon, France
Centre Hospitalier Alpes Léman
🇫🇷Contamine sur Arve, France
Centre Hospitalier de la Côte Basque
🇫🇷Bayonne, France
Centre Hospitalier de Laon
🇫🇷Laon, France
CH Montélimar
🇫🇷Montélimar, France
Centre Catherine de Sienne
🇫🇷Nantes, France
Centre Hospitalier de la Région d'Annecy
🇫🇷Pringy, France
Hopital privé des côtes d'armor
🇫🇷Plérin, France
Institut du Cancer Courlancy Reims
🇫🇷Reims, France
Centre Hospitalier de Quimper
🇫🇷Quimper, France
Hôpitaux Drôme Nord - Site de Romans
🇫🇷Romans-sur-isere, France
CHP Saint Grégoire
🇫🇷Saint Grégoire, France