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

NCT02585388 | Terminated Phase 2 DMC

• 1 other identifier: GINECO-BR112
• Study Type: interventional
• Target: 120
• Locations: 1 country
• Sites: 47

Brief Summary

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

Conditions

Breast Cancer

Keywords

pretreated metastatic breast cancer

Outcome Measures

Primary Outcomes (1)

• Progression free survival (PFS)

  Proportion of progression or death

  up to 6 months

Secondary Outcomes (6)

• Evaluation of partial and complete response rate by RECIST 1.1

  up to 6 months

• duration of response

  up to 6 months

• clinical benefit after 24 weeks of treatment

  up to 24 weeks

• overall survival

  up to 2 years

• Toxicity according to criteria NCI CTAEv4.03

  up to 2 years

Study Arms (2)

Vinorelbine

ACTIVE COMPARATOR

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.

Drug: Vinorelbine

Vinorelbine+Anastrozole or Letrozole

EXPERIMENTAL

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

Drug: Vinorelbine; Drug: Letrozole; Drug: Anastrozole

Interventions

Vinorelbine DRUG

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

Also known as: Navelbine

Vinorelbine; Vinorelbine+Anastrozole or Letrozole

Letrozole DRUG

Lestrozole at 2,5 mg every day , per oral

Also known as: ARM A

Vinorelbine+Anastrozole or Letrozole

Anastrozole DRUG

Anastrozole at 1 mg every day, per oral

Also known as: ARM B

Vinorelbine+Anastrozole or Letrozole

Eligibility Criteria

• Age: 50 Years - 95 Years
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age ≥ 50 years.
• Histologically proven breast cancer.
• Progesterone and /or oestrogene receptors positive.
• 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.
• Patient having to begin a second or third line of chemotherapy.
• 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.
• Post menopausal woman.
• ECOG 0, 1 or 2.
• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• ARCAGY/ GINECO GROUP: lead
• Pierre Fabre Laboratories: collaborator

Study Sites (47)

Centre Hospitalier de l'Agglomération Montargoise

Amilly, 45207, France

Location

ICO Paul Papin

Angers, 49933, France

Location

Institut Sainte-Catherine

Avignon, 84918, France

Location

Centre Hospitalier de la Côte Basque

Bayonne, 64109, France

Location

Centre Hospitalier Fleyriat

Bourg-en-Bresse, 01000, France

Location

CHU de Brest

Brest, 29200, France

Location

Clinique Pasteur

Brest, 29200, France

Location

Centre Hospitalier Alpes Léman

Contamine-sur-Arve, 74130, France

Location

CH de la Dracénie

Draguignan, 83300, France

Location

Centre Hospitalier Intercommunal des Alpes du Sud

Gap, 05007, France

Location

Groupe Hospitalier Mutualiste de Grenoble

Grenoble, 38028, France

Location

CHU de Grenoble

Grenoble, 38043, France

Location

Hôpital Privé Drôme Ardèche - Clinique Pasteur

Guilherand-Granges, 07500, France

Location

Hôpital Privé Drôme Ardèche

Guilhérand-Granges, 07500, France

Location

CHD Vendée

La Roche-sur-Yon, 85925, France

Location

Centre Hospitalier de Laon

Laon, 02000, France

Location

CH Chartres Hôpital Louis Pasteur

Le Coudray, 28630, France

Location

Centre Hospitalier Le Mans

Le Mans, 72000, France

Location

Centre Léon Berard

Lyon, 69008, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69008, France

Location

Hôpital Privé Jean Mermoz

Lyon, 69373, France

Location

CH Layne

Mont-de-Marsan, 40000, France

Location

CH Montélimar

Montélimar, 26216, France

Location

Centre Azuréen de Cancérologie

Mougins, 06250, France

Location

Oracle

Nancy, 54000, France

Location

Centre Catherine de Sienne

Nantes, 44202, France

Location

CHR Orléans

Orléans, 45100, France

Location

Centre Hospitalier de Pau

Pau, 64000, France

Location

Polyclinique Francheville

Périgueux, 24000, France

Location

Centre Hospitalier Lyon Sud

Pierre-Bénite, 69495, France

Location

Hopital privé des côtes d'armor

Plérin, 22191, France

Location

Centre Hospitalier Annecy-Genevois

Pringy, 74374, France

Location

Centre Hospitalier de la Région d'Annecy

Pringy, 74374, France

Location

Centre Hospitalier de Quimper

Quimper, 29107, France

Location

Institut du Cancer Courlancy Reims

Reims, 51100, France

Location

Institut Jean Godinot

Reims, 51726, France

Location

Centre Hospitalier de Romans sur Isère

Romans-sur-Isère, 26100, France

Location

Hôpitaux Drôme Nord - Site de Romans

Romans-sur-Isère, 26100, France

Location

CHP Saint Grégoire

Saint-Grégoire, 35750, France

Location

ICO Gauducheau

Saint-Herblain, 44800, France

Location

Polyclinique Côte Basque Sud

Saint-Jean-de-Luz, 64501, France

Location

Institut de Cancérologie Lucien Neuwirth

Saint-Priest-en-Jarez, 42271, France

Location

Centre Hospitalier de Soissons

Soissons, 02200, France

Location

Hôpitaux Universitaires de Strasbourg

Strasbourg, 67091, France

Location

Hôpitaux du Léman

Thonon-les-Bains, 74200, France

Location

Centre Hospitalier Jean Bernard

Valenciennes, 59322, France

Location

Institut de Cancérologie de Lorraine

Vandœuvre-lès-Nancy, 54519, France

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Vinorelbine; Letrozole; Anastrozole

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Vinca Alkaloids; Secologanin Tryptamine Alkaloids; Indole Alkaloids; Alkaloids; Heterocyclic Compounds; Indoles; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Indolizidines; Indolizines; Nitriles; Organic Chemicals; Triazoles; Azoles; Heterocyclic Compounds, 1-Ring

Study Officials

• Pierre-Etienne HEUDEL, MD

  Centre Leon Berard

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 22, 2015
• First Posted: October 23, 2015
• Study Start: October 23, 2015
• Primary Completion: May 15, 2017
• Study Completion: May 15, 2017
• Last Updated: September 6, 2023

Record last verified: 2023-09

Locations

FR (47)