Addition of Aromatase at the Navelbine in Pretreated Metastatic Breast Cancer.

Breast Cancer Clinical Trial

— CHEOPS  

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

Clinical Trial Details — Status: Terminated

Administrative data

• NCT number: NCT02585388
• Other study ID #: GINECO-BR112
• Status: Terminated
• Phase: Phase 2
• Start date: October 23, 2015
• Est. completion date: May 15, 2017

Study information

• Verified date: September 2023
• Source: ARCAGY/ GINECO GROUP
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The CHEOPS study aims to confirm the clinical benefit of a combination of an anti-aromatase and metronomic chemotherapy treatment

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 information / eligibility

• Status: Terminated
• Enrollment: 120
• Est. completion date: May 15, 2017
• Est. primary completion date: May 15, 2017
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 50 Years to 95 Years

Eligibility

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 .

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 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

Locations

Country	Name	City	State
France	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	CHU de Grenoble	Grenoble
France	Groupe Hospitalier Mutualiste 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	Perigueux
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-isere
France	CHP Saint Grégoire	Saint Grégoire
France	Institut de Cancérologie Lucien Neuwirth	Saint Priest en Jarez
France	Centre Hospitalier de Soissons	Soissons
France	ICO Gauducheau	St Herblain
France	Polyclinique Côte Basque Sud	St Jean de Luz
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	Vandoeuvre Les Nancy

Sponsors (2)

Lead Sponsor	Collaborator
ARCAGY/ GINECO GROUP	Pierre Fabre Laboratories

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Progression free survival (PFS)	Proportion of progression or death	up to 6 months
Secondary	Evaluation of partial and complete response rate by RECIST 1.1	partial and complete response rate by RECIST 1.1 in each arm	up to 6 months
Secondary	duration of response	duration of response is defined as the time from randomization and the disease progression	up to 6 months
Secondary	clinical benefit after 24 weeks of treatment	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	up to 24 weeks
Secondary	overall survival	the overall survival of patients randomized is defined as the time from randomization and the date of death	up to 2 years
Secondary	Toxicity according to criteria NCI CTAEv4.03	tolerance of the treatment based on AE occurrence according to criteria NCI CTAEv4.03	up to 2 years
Secondary	health-related quality of life	health-related quality of life and symptomatic state will be evaluated by filling a questionnaire by patients	up to 2 years