Clinical trial NCT02585388: Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.
Official title: A Randomized Phase II, Multicenter Study Evaluating the Benefit of Adding a Non Steroidal Aromatase Inhibitor to Oral Vinorelbine in Patients With Pretreated Metastatic Breast Cancer
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: pretreated metastatic breast cancer
Lead sponsor: ARCAGY/ GINECO GROUP
Sponsor class: OTHER
Collaborators: name: Pierre Fabre Laboratories
First posted: 2015-10-23
Enrollment: 120
Sex: FEMALE
Minimum age (years): 50
Maximum age (years): 95
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: Inclusion Criteria:

1. Age ≥ 50 years.
2. Histologically proven breast cancer.
3. Progesterone and /or oestrogene receptors positive.
4. HER2 negative on primary tumour.
5. 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.
6. Patient having to begin a second or third line of chemotherapy.
7. 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.
8. Post menopausal woman.
9. ECOG 0, 1 or 2.
10. 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.
11. Patient with a life expectancy greater than 3 months.
12. Signed informed consent before enrollment.
13. affiliation to a social security scheme

Exclusion Criteria:

1. Patient with located or single metastatic tumoral relapse, accessible to a surgical treatment.
2. Patient having already received more 2 lines of chemotherapy for metastatic or advanced decease
3. Patient having already received a treatment by Navelbine®
4. Patient requiring an immediate located radiotherapy for analgesic action
5. Patient with non-irradiated cerebral or symptomatic metastasis, symptomatic pulmonary carcinomatosis lymphangitis
6. Simultaneous administration of another chemotherapy hormonotherapy or anti-tumoral drug
7. Patient having already received another treatment ongoing evaluation within the 30 days before the screening visit
8. Known positive serology HIV
9. 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.
10. 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).
11. 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).
12. Known hypersensitivity to letrozole, anastrozole, vinorelbine or other vinco-alkaloids or any other component.
13. Patient with fructose intolerance, galactose, a Lapp lactase deficiency or malabsorption of glucose and galactose (rare hereditary disease).
14. Patient with a history of poor compliance with medical treatment.
15. Patient can not be monitored regularly for family reasons, geographical, social or psychological.
16. Patient with altered mental status would not allow him to understand the study or give informed consent .

Primary outcomes:
measure: Progression free survival (PFS)
timeFrame: up to 6 months
Secondary outcomes:
measure: Evaluation of partial and complete response rate by RECIST 1.1
timeFrame: up to 6 months
measure: duration of response
timeFrame: up to 6 months
measure: clinical benefit after 24 weeks of treatment
timeFrame: up to 24 weeks
measure: overall survival
timeFrame: up to 2 years
measure: Toxicity according to criteria NCI CTAEv4.03
timeFrame: up to 2 years
measure: health-related quality of life
timeFrame: up to 2 years
Other outcomes:
Locations:
city: Amilly
country: France
facility: Centre Hospitalier de l'Agglomération Montargoise
city: Angers
country: France
facility: ICO Paul Papin
city: Avignon
country: France
facility: Institut Sainte-Catherine
city: Bayonne
country: France
facility: Centre Hospitalier de la Côte Basque
city: Bourg-en-Bresse
country: France
facility: Centre Hospitalier Fleyriat
city: Brest
country: France
facility: CHU de Brest
city: Brest
country: France
facility: Clinique Pasteur
city: Contamine sur Arve
country: France
facility: Centre Hospitalier Alpes Léman
city: Draguignan
country: France
facility: CH de la Dracénie
city: Gap
country: France
facility: Centre Hospitalier Intercommunal des Alpes du Sud
city: Grenoble
country: France
facility: Groupe Hospitalier Mutualiste de Grenoble
city: Grenoble
country: France
facility: CHU de Grenoble
city: Guilherand-granges
country: France
facility: Hôpital Privé Drôme Ardèche - Clinique Pasteur
city: Guilhérand-Granges
country: France
facility: Hôpital Privé Drôme Ardèche
city: La Roche sur Yon
country: France
facility: CHD Vendée
city: Laon
country: France
facility: Centre Hospitalier de Laon
city: Le Coudray
country: France
facility: CH Chartres Hôpital Louis Pasteur
city: Le Mans
country: France
facility: Centre Hospitalier Le Mans
city: Lyon
country: France
facility: Centre Léon Berard
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Lyon
country: France
facility: Hôpital Privé Jean Mermoz
city: Mont de Marsan
country: France
facility: CH Layne
city: Montélimar
country: France
facility: CH Montélimar
city: Mougins
country: France
facility: Centre Azuréen de Cancérologie
city: Nancy
country: France
facility: Oracle
city: Nantes
country: France
facility: Centre Catherine de Sienne
city: Orléans
country: France
facility: CHR Orléans
city: Pau
country: France
facility: Centre Hospitalier de Pau
city: Perigueux
country: France
facility: Polyclinique Francheville
city: Pierre-Bénite
country: France
facility: Centre Hospitalier Lyon Sud
city: Plérin
country: France
facility: Hopital privé des côtes d'armor
city: Pringy
country: France
facility: Centre Hospitalier Annecy-Genevois
city: Pringy
country: France
facility: Centre Hospitalier de la Région d'Annecy
city: Quimper
country: France
facility: Centre Hospitalier de Quimper
city: Reims
country: France
facility: Institut du Cancer Courlancy Reims
city: Reims
country: France
facility: Institut Jean Godinot
city: Romans sur Isère
country: France
facility: Centre Hospitalier de Romans sur Isère
city: Romans-sur-isere
country: France
facility: Hôpitaux Drôme Nord - Site de Romans
city: Saint Grégoire
country: France
facility: CHP Saint Grégoire
city: Saint Priest en Jarez
country: France
facility: Institut de Cancérologie Lucien Neuwirth
city: Soissons
country: France
facility: Centre Hospitalier de Soissons
city: St Herblain
country: France
facility: ICO Gauducheau
city: St Jean de Luz
country: France
facility: Polyclinique Côte Basque Sud
city: Strasbourg
country: France
facility: Hôpitaux Universitaires de Strasbourg
city: Thonon-Les-Bains
country: France
facility: Hôpitaux du Léman
city: Valenciennes
country: France
facility: Centre Hospitalier Jean Bernard
city: Vandoeuvre Les Nancy
country: France
facility: Institut de Cancérologie de Lorraine
Study officials:
affiliation: Centre Leon Berard
name: Pierre-Etienne HEUDEL, MD
role: PRINCIPAL_INVESTIGATOR
References: