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Breast CancerPhase 2CHEOPSNCT02585388

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

A Phase 2 study testing Vinorelbine, Letrozole and Anastrozole in people with Breast Cancer, run by ARCAGY/ GINECO GROUP at 47 sites in France.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record
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Trial summary

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

Who is it for?
Ages 50 to 95 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Vinorelbine, Letrozole and Anastrozole
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
120 participants
Where
47 sitesFrance
Study dates
23 Oct 2015to 15 May 2017
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 95 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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.
Show all 19Show fewer
  • 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
  • ALT, AST ≤ 1,5 x ULN in the absence of liver metastases or ≤ 3 x ULN if liver metastases.
  • Patient with a life expectancy greater than 3 months.
  • Signed informed consent before enrollment.
  • affiliation to a social security scheme

Who cannot join

  • 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
Show all 16Show fewer
  • 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.
  • Patient with altered mental status would not allow him to understand the study or give informed consent .

Trial locations and contacts

47 sites in 1 country.

47 sites in 1 country

France47 sites

  • Centre Hospitalier de l'Agglomération Montargoise

    Amilly, 45207

  • ICO Paul Papin

    Angers, 49933

  • Institut Sainte-Catherine

    Avignon, 84918

  • Centre Hospitalier de la Côte Basque

    Bayonne, 64109

  • Centre Hospitalier Fleyriat

    Bourg-en-Bresse, 01000

  • CHU de Brest

    Brest, 29200

  • Clinique Pasteur

    Brest, 29200

  • Centre Hospitalier Alpes Léman

    Contamine-sur-Arve, 74130

  • CH de la Dracénie

    Draguignan, 83300

  • Centre Hospitalier Intercommunal des Alpes du Sud

    Gap, 05007

  • Groupe Hospitalier Mutualiste de Grenoble

    Grenoble, 38028

  • CHU de Grenoble

    Grenoble, 38043

  • Hôpital Privé Drôme Ardèche - Clinique Pasteur

    Guilherand-Granges, 07500

  • Hôpital Privé Drôme Ardèche

    Guilhérand-Granges, 07500

  • CHD Vendée

    La Roche-sur-Yon, 85925

  • Centre Hospitalier de Laon

    Laon, 02000

  • CH Chartres Hôpital Louis Pasteur

    Le Coudray, 28630

  • Centre Hospitalier Le Mans

    Le Mans, 72000

  • Centre Léon Berard

    Lyon, 69008

  • Hôpital Privé Jean Mermoz

    Lyon, 69008

  • Hôpital Privé Jean Mermoz

    Lyon, 69373

  • CH Layne

    Mont-de-Marsan, 40000

  • CH Montélimar

    Montélimar, 26216

  • Centre Azuréen de Cancérologie

    Mougins, 06250

  • Oracle

    Nancy, 54000

  • Centre Catherine de Sienne

    Nantes, 44202

  • CHR Orléans

    Orléans, 45100

  • Centre Hospitalier de Pau

    Pau, 64000

  • Polyclinique Francheville

    Périgueux, 24000

  • Centre Hospitalier Lyon Sud

    Pierre-Bénite, 69495

  • Hopital privé des côtes d'armor

    Plérin, 22191

  • Centre Hospitalier Annecy-Genevois

    Pringy, 74374

  • Centre Hospitalier de la Région d'Annecy

    Pringy, 74374

  • Centre Hospitalier de Quimper

    Quimper, 29107

  • Institut du Cancer Courlancy Reims

    Reims, 51100

  • Institut Jean Godinot

    Reims, 51726

  • Centre Hospitalier de Romans sur Isère

    Romans-sur-Isère, 26100

  • Hôpitaux Drôme Nord - Site de Romans

    Romans-sur-Isère, 26100

  • CHP Saint Grégoire

    Saint-Grégoire, 35750

  • ICO Gauducheau

    Saint-Herblain, 44800

  • Polyclinique Côte Basque Sud

    Saint-Jean-de-Luz, 64501

  • Institut de Cancérologie Lucien Neuwirth

    Saint-Priest-en-Jarez, 42271

  • Centre Hospitalier de Soissons

    Soissons, 02200

  • Hôpitaux Universitaires de Strasbourg

    Strasbourg, 67091

  • Hôpitaux du Léman

    Thonon-les-Bains, 74200

  • Centre Hospitalier Jean Bernard

    Valenciennes, 59322

  • Institut de Cancérologie de Lorraine

    Vandœuvre-lès-Nancy, 54519

Other trials in France

About this study

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

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

Read the 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.

Conditions
Breast Cancer
Keywords
pretreated metastatic breast cancer
Medical subject headings
Breast Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • VinorelbineDrug

    Also called Navelbine

    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

  • LetrozoleDrug

    Also called ARM A

    Lestrozole at 2,5 mg every day , per oral

  • AnastrozoleDrug

    Also called ARM B

    Anastrozole at 1 mg every day, per oral

Study groups in NCT02585388
Study groupRoleWhat they receive
VinorelbineActive comparatorVinorelbine (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.
Receives: Drug: Vinorelbine
Vinorelbine+Anastrozole or LetrozoleExperimentalVinorelbine 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
Receives: Drug: Vinorelbine; Drug: Letrozole; Drug: Anastrozole

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Progression free survival (PFS)

    Proportion of progression or death

    Measured: up to 6 months

Secondary outcomes (6)

  1. Evaluation of partial and complete response rate by RECIST 1.1

    partial and complete response rate by RECIST 1.1 in each arm

    Measured: up to 6 months

  2. duration of response

    duration of response is defined as the time from randomization and the disease progression

    Measured: up to 6 months

  3. 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

    Measured: up to 24 weeks

  4. overall survival

    the overall survival of patients randomized is defined as the time from randomization and the date of death

    Measured: up to 2 years

  5. Toxicity according to criteria NCI CTAEv4.03

    tolerance of the treatment based on AE occurrence according to criteria NCI CTAEv4.03

    Measured: up to 2 years

  6. health-related quality of life

    health-related quality of life and symptomatic state will be evaluated by filling a questionnaire by patients

    Measured: up to 2 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted23 Oct 2015 (estimated)
  2. Study start23 Oct 2015
  3. Primary completion15 May 2017
  4. Study completion15 May 2017

Why it stopped: Treatment toxicity

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
120 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT02585388
Sponsor's protocol ID
GINECO-BR112
Acronym
CHEOPS
Status last verified
Sep 2023
First submitted
22 Oct 2015
Last updated
6 Sep 2023
Results posted
No
Data monitoring committee
Yes

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Vinorelbine, Letrozole and Anastrozole in people with Breast Cancer, run by ARCAGY/ GINECO GROUP at 47 sites in France.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 19 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: stopped early, as of the sponsor's last update on 6 Sep 2023. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 47 sites in France. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study was stopped early (reason given: Treatment toxicity). Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression free survival (PFS) (time frame: up to 6 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02585388.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 6 Sep 2023.

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