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

Status

Indicates the current recruitment status or the expanded access status.
Terminated

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
120

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

  • France
      • 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 Côte 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 Leman
      • 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
        • Hopital Prive Drome Ardeche
      • 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 Léon Bérard
      • Lyon, France, 69008
        • Hôpital privé Jean Mermoz
      • Lyon, France, 69373
        • Hôpital privé Jean Mermoz
      • Mont de Marsan, France, 40000
        • CH Layné
      • 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 Orléans
      • Pau, France, 64000
        • Centre Hospitalier de Pau
      • Perigueux, France, 24000
        • Polyclinique Francheville
      • Pierre-Bénite, France, 69495
        • Centre Hospitalier LYON SUD
      • Plérin, France, 22191
        • Hôpital Privé Des Côtes 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 Isere
      • Romans-sur-isere, France, 26100
        • Hôpitaux Drôme Nord - Site de Romans
      • Saint Grégoire, France, 35750
        • CHP Saint Grégoire
      • Saint Priest en Jarez, France, 42271
        • Institut de Cancérologie 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
        • Hopitaux du Leman
      • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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.
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
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
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
Other Names:
  • Navelbine
Drug: Letrozole
Lestrozole at 2,5 mg every day , per oral
Other Names:
  • ARM A
Drug: Anastrozole
Anastrozole at 1 mg every day, per oral
Other Names:
  • ARM B

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
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.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
ARCAGY/ GINECO GROUP

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
Pierre Fabre Laboratories

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Pierre-Etienne HEUDEL, MD, Centre Léon Bérard

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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
October 23, 2015

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 15, 2017

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 15, 2017

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 22, 2015

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
October 22, 2015

First Posted (Estimated)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
October 23, 2015

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
September 6, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
September 5, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
September 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • GINECO-BR112

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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