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

September 5, 2023 updated by: ARCAGY/ GINECO GROUP

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

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

Study Overview

Status

Terminated

Conditions

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.

Study Type

Interventional

Enrollment (Actual)

120

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

      • Amilly, France, 45207
        • Centre Hospitalier de l'Agglomération Montargoise
      • Angers, France, 49933
        • ICO Paul Papin
      • Avignon, France, 84918
        • Institut Sainte-Catherine
      • Bayonne, France, 64109
        • Centre Hospitalier de la Cote Basque
      • Bourg-en-Bresse, France, 01000
        • Centre Hospitalier Fleyriat
      • Brest, France, 29200
        • Clinique Pasteur
      • Brest, France, 29200
        • CHU de Brest
      • Contamine sur Arve, France, 74130
        • Centre Hospitalier Alpes Léman
      • Draguignan, France, 83300
        • CH de la Dracénie
      • Gap, France, 05007
        • Centre Hospitalier Intercommunal des Alpes du Sud
      • Grenoble, France, 38043
        • CHU de Grenoble
      • Grenoble, France, 38028
        • Groupe Hospitalier Mutualiste de Grenoble
      • Guilherand-granges, France, 07500
        • Hôpital privé Drôme Ardèche - Clinique Pasteur
      • Guilhérand-Granges, France, 07500
        • Hôpital privé Drôme Ardèche
      • La Roche sur Yon, France, 85925
        • CHD Vendée
      • Laon, France, 02000
        • Centre Hospitalier de Laon
      • Le Coudray, France, 28630
        • CH Chartres Hôpital Louis Pasteur
      • Le Mans, France, 72000
        • Centre Hospitalier Le Mans
      • Lyon, France, 69008
        • Centre Leon Berard
      • Lyon, France, 69008
        • Hopital Privé Jean Mermoz
      • Lyon, France, 69373
        • Hopital Privé Jean Mermoz
      • Mont de Marsan, France, 40000
        • CH Layne
      • Montélimar, France, 26216
        • CH Montélimar
      • Mougins, France, 06250
        • Centre Azuréen de Cancérologie
      • Nancy, France, 54000
        • Oracle
      • Nantes, France, 44202
        • Centre Catherine De Sienne
      • Orléans, France, 45100
        • CHR Orleans
      • Pau, France, 64000
        • Centre Hospitalier de Pau
      • Perigueux, France, 24000
        • Polyclinique Francheville
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier Lyon Sud
      • Plérin, France, 22191
        • Hopital Privé des Cotes d'Armor
      • Pringy, France, 74374
        • Centre Hospitalier Annecy-Genevois
      • Pringy, France, 74374
        • Centre Hospitalier de la Région d'Annecy
      • Quimper, France, 29107
        • Centre Hospitalier de Quimper
      • Reims, France, 51726
        • Institut Jean Godinot
      • Reims, France, 51100
        • Institut du Cancer Courlancy Reims
      • Romans sur Isère, France, 26100
        • Centre Hospitalier de Romans sur Isère
      • Romans-sur-isere, France, 26100
        • Hôpitaux Drôme Nord - Site de Romans
      • Saint Grégoire, France, 35750
        • CHP Saint Gregoire
      • Saint Priest en Jarez, France, 42271
        • Institut de Cancerologie Lucien Neuwirth
      • Soissons, France, 02200
        • Centre Hospitalier de Soissons
      • St Herblain, France, 44800
        • ICO Gauducheau
      • St Jean de Luz, France, 64501
        • Polyclinique Côte Basque Sud
      • Strasbourg, France, 67091
        • Hopitaux Universitaires De Strasbourg
      • Thonon-Les-Bains, France, 74200
        • Hôpitaux du Léman
      • Valenciennes, France, 59322
        • Centre Hospitalier Jean Bernard
      • Vandoeuvre Les Nancy, France, 54519
        • Institut de Cancérologie de Lorraine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

50 years to 95 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

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 .

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: 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 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
Other Names:
  • Navelbine
Experimental: 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 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
Other Names:
  • Navelbine
Lestrozole at 2,5 mg every day , per oral
Other Names:
  • ARM A
Anastrozole at 1 mg every day, per oral
Other Names:
  • ARM B

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Progression free survival (PFS)
Time Frame: up to 6 months
Proportion of progression or death
up to 6 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Pierre-Etienne HEUDEL, MD, Centre Leon Berard

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 23, 2015

Primary Completion (Actual)

May 15, 2017

Study Completion (Actual)

May 15, 2017

Study Registration Dates

First Submitted

October 22, 2015

First Submitted That Met QC Criteria

October 22, 2015

First Posted (Estimated)

October 23, 2015

Study Record Updates

Last Update Posted (Actual)

September 6, 2023

Last Update Submitted That Met QC Criteria

September 5, 2023

Last Verified

September 1, 2023

More Information

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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