Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.
NCT ID: NCT02585388
Last Updated: 2023-09-06
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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TERMINATED
PHASE2
120 participants
INTERVENTIONAL
2015-10-23
2017-05-15
Brief Summary
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Detailed Description
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Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
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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
Vinorelbine metronomic at 50 mg (1 tablet at 20 mg and 1 tablet at 30mg),per oral, 3 times per week. One dose level reduction is authorized at 30 mg per day.when stopping over 3 consecutive weeks due to toxicity, treatment should be permanently discontinued
Vinorelbine+Anastrozole or 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
Vinorelbine metronomic at 50 mg (1 tablet at 20 mg and 1 tablet at 30mg),per oral, 3 times per week. One dose level reduction is authorized at 30 mg per day.when stopping over 3 consecutive weeks due to toxicity, treatment should be permanently discontinued
Letrozole
Lestrozole at 2,5 mg every day , per oral
Anastrozole
Anastrozole at 1 mg every day, per oral
Interventions
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Vinorelbine
Vinorelbine metronomic at 50 mg (1 tablet at 20 mg and 1 tablet at 30mg),per oral, 3 times per week. One dose level reduction is authorized at 30 mg per day.when stopping over 3 consecutive weeks due to toxicity, treatment should be permanently discontinued
Letrozole
Lestrozole at 2,5 mg every day , per oral
Anastrozole
Anastrozole at 1 mg every day, per oral
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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 .
50 Years
95 Years
FEMALE
No
Sponsors
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Pierre Fabre Laboratories
INDUSTRY
ARCAGY/ GINECO GROUP
OTHER
Responsible Party
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Principal Investigators
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Pierre-Etienne HEUDEL, MD
Role: PRINCIPAL_INVESTIGATOR
Centre Leon Berard
Locations
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Centre Hospitalier de l'Agglomération Montargoise
Amilly, , France
ICO Paul Papin
Angers, , France
Institut Sainte-Catherine
Avignon, , France
Centre Hospitalier de la Côte Basque
Bayonne, , France
Centre Hospitalier Fleyriat
Bourg-en-Bresse, , France
CHU de Brest
Brest, , France
Clinique Pasteur
Brest, , France
Centre Hospitalier Alpes Léman
Contamine-sur-Arve, , France
CH de la Dracénie
Draguignan, , France
Centre Hospitalier Intercommunal des Alpes du Sud
Gap, , France
Groupe Hospitalier Mutualiste de Grenoble
Grenoble, , France
CHU de Grenoble
Grenoble, , France
Hôpital Privé Drôme Ardèche - Clinique Pasteur
Guilherand-Granges, , France
Hôpital Privé Drôme Ardèche
Guilhérand-Granges, , France
CHD Vendée
La Roche-sur-Yon, , France
Centre Hospitalier de Laon
Laon, , France
CH Chartres Hôpital Louis Pasteur
Le Coudray, , France
Centre Hospitalier Le Mans
Le Mans, , France
Centre Léon Berard
Lyon, , France
Hôpital Privé Jean Mermoz
Lyon, , France
Hôpital Privé Jean Mermoz
Lyon, , France
CH Layne
Mont-de-Marsan, , France
CH Montélimar
Montélimar, , France
Centre Azuréen de Cancérologie
Mougins, , France
Oracle
Nancy, , France
Centre Catherine de Sienne
Nantes, , France
CHR Orléans
Orléans, , France
Centre Hospitalier de Pau
Pau, , France
Polyclinique Francheville
Périgueux, , France
Centre Hospitalier Lyon Sud
Pierre-Bénite, , France
Hopital privé des côtes d'armor
Plérin, , France
Centre Hospitalier Annecy-Genevois
Pringy, , France
Centre Hospitalier de la Région d'Annecy
Pringy, , France
Centre Hospitalier de Quimper
Quimper, , France
Institut du Cancer Courlancy Reims
Reims, , France
Institut Jean Godinot
Reims, , France
Centre Hospitalier de Romans sur Isère
Romans-sur-Isère, , France
Hôpitaux Drôme Nord - Site de Romans
Romans-sur-Isère, , France
CHP Saint Grégoire
Saint-Grégoire, , France
ICO Gauducheau
Saint-Herblain, , France
Polyclinique Côte Basque Sud
Saint-Jean-de-Luz, , France
Institut de Cancérologie Lucien Neuwirth
Saint-Priest-en-Jarez, , France
Centre Hospitalier de Soissons
Soissons, , France
Hôpitaux Universitaires de Strasbourg
Strasbourg, , France
Hôpitaux du Léman
Thonon-les-Bains, , France
Centre Hospitalier Jean Bernard
Valenciennes, , France
Institut de Cancérologie de Lorraine
Vandœuvre-lès-Nancy, , France
Countries
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Other Identifiers
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GINECO-BR112
Identifier Type: -
Identifier Source: org_study_id
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