Safety and Efficacy Comparison of Docetaxel and Ixabepilone in Non Metastatic Poor Prognosis Breast Cancer (TavIx)

February 20, 2024 updated by: UNICANCER

Randomized, Open Label, Multicentric Phase III Evaluating the Benefit of a Sequential Regimen Associating FEC 100 and Ixabepilone in Adjuvant Treatment of Non Metastatic, Poor Prognosis Breast Cancer Defined as Triple-negative Tumor [HER2 Negative - ER Negative - PR Negative] or [HER2 Negative and PR Negative] Tumor; in Node Positive or Node Negative Patients.

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) and giving them after surgery may kill any tumor cells remaining after surgery. It is not yet known whether docetaxel is more effective than ixabepilone when given after surgery and combination chemotherapy in treating breast cancer.

PURPOSE: This randomized phase III trial is studying giving combination chemotherapy followed by docetaxel or ixabepilone to compare how well they work in treating patients who have undergone surgery for nonmetastatic breast cancer.

Study Overview

Status

Status

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

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

OBJECTIVES:

Primary

  • To evaluate the benefit from sequential administration of 3 courses of combination chemotherapy (FEC100) followed by 3 courses of ixabepilone versus docetaxel on the 5-year disease-free survival of women with nonmetastatic, poor-prognosis breast cancer.

Secondary

  • To compare the 5-year distant metastasis-free survival.
  • To compare the 5-year event-free survival.
  • To compare the 5-year overall survival.
  • To compare the safety profiles for the two chemotherapy regimens.
  • To identify and/or validate predictive-gene expression profiles of clinical response/resistance to the two treatment regimens.
  • To bank frozen and fixed tumor and frozen serum prospectively for future translational studies in both genomics and proteomics (transcriptome and proteome analyses, tissue array analyses).
  • To compare the cost-effectiveness of these 2 regimens.
  • To compare the quality-of-life of patients treated with these 2 regimens.

OUTLINE: This is a multicenter study. Patients are stratified according to participating center, menopausal status (pre- vs post-menopausal), and tumor hormone-receptor status (triple-negative vs progesterone-receptor negative, HER negative, and estrogen-receptor [ER] positive). Patients are randomized to 1 of 2 treatment arms.

  • Docetaxel Arm: Patients receive epirubicin hydrochloride IV, fluorouracil IV, and cyclophosphamide IV every 3 weeks in courses 1-3 and docetaxel IV alone every 3 weeks in courses 4-6.
  • Ixabepilone Arm: Patients receive treatment in courses 1-3 as in arm I and ixabepilone IV alone every 3 weeks in courses 4-6.

In both arms, courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Patients also complete a quality of life questionnaire periodically.

After completion of study treatment, patients are followed periodically for up to 10 years.

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.
762

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 3

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

  • Belgium
      • Brussels, Belgium, 1000
        • Institut Jules Bordet
      • Chimay, Belgium, B-6460
        • Centre de Sante des Fagnes
      • Huy, Belgium, 4500
        • Centre Hospitalier Hutois
      • Kortrijk, Belgium, B-8500
        • Cazk Groeninghe - Campus Maria's Voorzienigheid
      • Mons, Belgium, B-7000
        • CHR - Clinique Saint Joseph - Hopital de Warqueguies
      • Ottignies, Belgium, B-1340
        • Clinique Saint-PIerre
      • Yvoir, Belgium, 5530
        • Clinique Universitaire De Mont-Godinne
  • France
      • Albi, France, 81000
        • Clinique Claude Bernard
      • Angers, France, 49036
        • Centre Paul Papin
      • Annecy, France, 74011 Cedex
        • Centre hospitalier d'Annecy
      • Auxerre, France, 89011
        • Centre Hospitalier D'Auxerre
      • Avignon, France, 84082
        • Institut Sainte Catherine
      • Blois, France, 41000
        • Centre Hospitalier de Blois
      • Bordeaux, France, 33076
        • Institut Bergonie
      • Bordeaux, France, F-33000
        • Clinique Tivoli
      • Boulogne Sur Mer, France, 62200
        • Centre Hospitalier Docteur Duchenne
      • Bourg-En-Bresse, France, 01012
        • Centre Hospitalier De Fleyriat
      • Brest, France, 29609
        • CHU Hopital A. Morvan
      • Caen, France, 14076
        • Centre Regional Francois Baclesse
      • Chambery, France, 73011
        • Centre Hospitalier Regional de Chambery
      • Chateaubriant cedex, France, 44110
        • Centre Hospitalier de Chateaubriant
      • Clermont-Ferrand, France, 63011
        • Centre Jean Perrin
      • Cornebarrieu, France, 31700
        • Clinique des Cèdres
      • Creteil, France, 94010
        • Hôpital Intercommunal de Créteil
      • Dax, France, 40107
        • Centre Hospitalier de Dax
      • Dijon, France, 21079
        • Centre de Lutte Contre le Cancer Georges-Francois Leclerc
      • Epinal, France, 88021
        • Hopital Jean Monnet
      • Ermont, France, 95120
        • Clinique Claude Bernard
      • Le Chesnay, France, 78157
        • Hôpital André Mignot
      • Le Havre, France, 76600
        • CMC Les Ormeaux
      • Lormont, France, 33310
        • Polyclinique des Quatre Pavillons
      • Lyon, France, 69373
        • Centre Léon Bérard
      • Mareuil Les Meaux, France, 77100
        • Centre de Radiotherapie et Oncologie Saint-Faron
      • Marseille, France, 13273
        • Marseille Institute of Cancer - Institut J. Paoli and I. Calmettes
      • Metz, France, 57038
        • Hopital Notre-Dame de Bon Secours
      • Metz, France, 57070
        • Hôpital Clinique Claude Bernard
      • Mont-de-Marsan, France, 40000
        • Centre Hospitalier General de Mont de Marsan
      • Montauban, France, 82017
        • Clinique Du Pont De Chaume
      • Montfermeil, France, 93370
        • Centre Hospitalier Intercommunal Le Raincy - Montfermeil
      • Montlucon, France, 03113
        • Centre Hospitalier de Montluçon
      • Mulhouse, France, 68070
        • Centre Hospitalier
      • Muret, France, 31600
        • Clinique D'Occitanie
      • Neuilly sur Seine, France, 92200
        • Clinique Hartmann
      • Nice, France, 06189
        • Centre Antoine Lacassagne
      • Nimes, France, 30907
        • Clinique De Valdegour
      • Paris, France, 75015
        • Hopital Saint Michel
      • Paris, France, 75248
        • Institut Curie Hopital
      • Pau, France, 64046
        • Centre Hospitalier - Pau
      • Perigueux, France, 24004
        • Polyclinique Francheville
      • Perpignan, France, 66000
        • Centre Hospitalier de Perpignan
      • Reims, France, F-51100
        • Polyclinique de Courlancy
      • Reims, France, 51056
        • Institut Jean Godinot
      • Rennes, France, 35042
        • Centre Eugene Marquis
      • Rodez, France, 12027
        • Centre Hospitalier de Rodez
      • Saint Brieuc, France, F-22015
        • Clinique Armoricaine de Radiologie
      • Saint Cloud, France, 92211
        • Centre René Huguenin
      • Saint Jean, France, 31240
        • Clinique de l'Union
      • Saint Priest en Jarez, France, 42270
        • Institut de Cancérologie de la Loire
      • Saint-Herblain, France, 44805
        • Centre Regional Rene Gauducheau
      • Strasbourg, France, 67065
        • Centre Paul Strauss
      • Strasbourg, France, 67000
        • Clinique de l'Orangerie
      • Tarbes, France, 65000
        • Polyclinique de l'Ormeau
      • Thionville, France, 57312
        • Centre Hospitalier Régional Metz Thionville
      • Toulouse, France, 31052
        • Institut Claudius Regaud
      • Toulouse, France, 31078
        • Clinique du Parc
      • Tours, France, 37044
        • Centre Hospitalier Universitaire Bretonneau de Tours
      • Vandoeuvre-les-Nancy, France, 54511
        • Centre Alexis Vautrin
      • Vannes, France, 56001
        • Centre d'oncologie Saint-Yves
      • Villejuif, France, F-94805
        • Institut Gustave Roussy
  • United States
    • Arizona
      • Scottsdale, Arizona, United States, 85259-5499
        • Mayo Clinic Scottsdale
    • Colorado
      • Denver, Colorado, United States, 80224
        • CCOP - Colorado Cancer Research Program
    • Florida
      • Jacksonville, Florida, United States, 32224
        • Mayo Clinic - Jacksonville
    • Indiana
      • South Bend, Indiana, United States, 46601
        • CCOP - Northern Indiana CR Consortium
    • Iowa
      • Cedar Rapids, Iowa, United States, 52403-1206
        • CCOP - Cedar Rapids Oncology Project
      • Sioux City, Iowa, United States, 51101-1733
        • Siouxland Hematology-Oncology Associates, LLP
    • Kansas
      • Wichita, Kansas, United States, 67214-3728
        • Cancer Center of Kansas, PA - Wichita
    • Minnesota
      • Duluth, Minnesota, United States, 55805-1983
        • Duluth Clinic Cancer Center - Duluth
      • Rochester, Minnesota, United States, 55905
        • Mayo Clinic Cancer Center
      • Saint Louis Park, Minnesota, United States, 55416
        • CCOP - Metro-Minnesota
    • Nebraska
      • Lincoln, Nebraska, United States, 68510
        • Southeast Nebraska Hematology Oncology Consultants at Southeast Nebraska Cancer Center
      • Omaha, Nebraska, United States, 68106
        • CCOP - Missouri Valley Cancer Consortium
    • North Dakota
      • Fargo, North Dakota, United States, 58122
        • Roger Maris Cancer Center at MeritCare Hospital
    • Ohio
      • Dayton, Ohio, United States, 45429
        • CCOP - Dayton
    • Pennsylvania
      • Danville, Pennsylvania, United States, 17822-2001
        • CCOP - Geisinger Clinic and Medical Center
    • South Dakota
      • Rapid City, South Dakota, United States, 57701
        • Oncology Associates at Rapid City Regional Hospital
    • Wisconsin
      • Green Bay, Wisconsin, United States, 54303
        • Green Bay Oncology, Limited at St. Mary's Hospital

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

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

DISEASE CHARACTERISTICS:

Inclusion criteria:

  • Histologically proven invasive unilateral breast cancer (regardless of the type)

    • Initial clinical condition compatible with complete initial resection
    • No residual macro or microscopic tumor after surgical excision

  • Node-positive disease (i.e., positive sentinel node or positive axillary clearance) (N+) or node-negative disease (-) meeting the following criteria :

    • Stage II or III disease
    • pT >20 mm (T1-4)

  • Patients must meet 1 of the following hormone-receptor criteria:

    • Node-positive patients: triple-negative* tumor (HER2 negative, estrogen-receptor [ER] negative, and progesterone receptor [PR] negative) OR double-negative (HER2 negative, PR negative, and ER+)
    • Node-negative patients: triple-negative* tumor only
  • NOTE: *Hormone-receptor negativity is defined as ER <10% and PR <10% by IHC and HER2 negativity is defined as IHC 0-1+ OR IHC 2+ and FISH or CISH negative
  • Must be able to begin chemotherapy no later than day 49 after the initial surgery

Exclusion criteria:

  • Clinically or radiologically detectable metastases (M0)
  • Bilateral breast cancer or contralateral ductal carcinoma in situ
  • Any metastatic impairment, including homolateral subclavicular node involvement, regardless of its type
  • Any tumor ≥T4a (cutaneous invasion, deep adherence, inflammatory breast cancer)
  • HER 2 overexpression defined as IHC 3+ OR IHC 2+ and FISH or CISH positive
  • Any clinically or radiologically suspect and non-explored damage to the contralateral breast

PATIENT CHARACTERISTICS:

Inclusion criteria:

  • Female
  • Pre- or postmenopausal
  • ECOG performance status 0-1
  • Peripheral neuropathy ≤grade 1
  • Neutrophil count ≥2,000/mm³
  • Platelet count ≥100,000/mm³
  • Hemoglobin >9 g/dL
  • AST and ALT ≤1.5 times upper limit of normal (ULN)
  • Alkaline phosphatase ≤2.5 times ULN
  • Total bilirubin ≤1.0 times ULN
  • Serum creatinine ≤1.5 times ULN
  • LVEF ≥50% by MUGA scan or echocardiography
  • Not pregnant or nursing
  • Negative pregnancy test
  • Fertile patients must use effective contraception during and for up to 8 weeks after completion of study treatment

Exclusion criteria:

  • Previous cancer (except cutaneous baso-cellular epithelioma or uterine peripheral epithelioma) in the preceding 5 years, including invasive contralateral breast cancer
  • Patients with any other concurrent severe and/or uncontrolled medical disease or infection that could compromise participation in the study

  • Clinically significant cardiovascular disease within the past 6 months including any of the following:

    • Unstable angina
    • Congestive heart failure
    • Uncontrolled hypertension (i.e., blood pressure >150/90 mm Hg)
    • Myocardial infarction
    • Cerebral vascular accidents
  • Known prior severe hypersensitivity reactions to agents containing Cremophor EL
  • Patients with any psychological, familial, sociological, or geographical condition potentially hampering compliance with the study protocol and follow-up schedule
  • Patients deprived of liberty or placed under the authority of a tutor

PRIOR CONCURRENT THERAPY:

  • At least 2 weeks since prior minor surgery (excluding breast biopsy) and adequately recovered
  • At least 3 weeks since prior major surgery and adequately recovered
  • No prior chemotherapy, hormonal therapy, or radiotherapy

  • More than 72 hours since prior and no concurrent treatment with any of the following strong inhibitors of CYP3A4:

    • Amiodarone
    • Clarithromycin
    • Amprenavir
    • Delavirdine
    • Voriconazole
    • Erythromycin
    • Fluconazole
    • Itraconazole
    • Ketoconazole
    • Indinavir
    • Nelfinavir
    • Ritonavir
    • Saquinavir
  • No concurrent participation in another therapeutic trial involving an experimental drug

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: Docetaxel
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of D (100 mg/m² every 3 weeks)
Drug: cyclophosphamide
500 mg/m² every 3 weeks
Drug: Docetaxel
100 mg/m² every 3 weeks
Drug: epirubicin hydrochloride
100 mg/m² every 3 weeks
Drug: fluorouracil
500 mg/m² every 3 weeks
Experimental: Ixabepilone
3 cycles of FEC100 (F and C, each at 500 mg/m², E 100 mg/m², every 3 weeks) followed by 3 cycles of Ixabepilone (40 mg/m² every 3 weeks);
Drug: cyclophosphamide
500 mg/m² every 3 weeks
Drug: epirubicin hydrochloride
100 mg/m² every 3 weeks
Drug: fluorouracil
500 mg/m² every 3 weeks
Drug: ixabepilone
40 mg/m² every 3 weeks

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
Percentage of Participants With Disease-free Survival (DFS)
Time Frame: At 5 years
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first
At 5 years

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
Number of Disease-free Survival Events for Triple-negative Subgroup
Time Frame: At 5 years
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with triple negative breast cancer only.
At 5 years
Number of Disease-free Survival Events for ER+/PR-/HER2- Subgroup
Time Frame: At 5 years
DFS is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or death from any cause, whichever occurs first in participants with ER+/PR-/HER2- breast cancer only.
At 5 years
Number of Distant Metastasis-free Survival Events for the Whole Population
Time Frame: At 5 years
The distant metastases-free survival is the length of time during and after the treatment for cancer that a patient is still alive and the cancer has not spread to other parts of the body.
At 5 years
Number of Event-free Survival
Time Frame: At 5 years
The Event-free Survival is defined as the interval between the date of randomization and the date of breast cancer relapse (local, regional or distant) or the date of invasive contralateral breast cancer or the date of second neoplasia, or the date of death from any cause, whichever occurs first.
At 5 years
Overall Survival
Time Frame: At 5 years
The overall survival is the length of time from randomization that patients enrolled in the study are still alive.
At 5 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.
UNICANCER

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: Mario Campone, MD, ICO Centre Regional Rene Gauducheau

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Helpful Links

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.
September 1, 2007

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.
June 1, 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.
September 3, 2020

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).
March 5, 2008

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.
March 5, 2008

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.
March 6, 2008

Study Record Updates

Last Update Posted (Estimated)

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.
February 21, 2024

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.
February 20, 2024

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.
February 1, 2024

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.
  • PACS08 - UC-0140/0610
  • PACS-08/0610 (Other Identifier: UNICANCER)
  • 2006-006494-24 (EudraCT Number)
  • PACS08-Tavlx (Other Identifier: UNICANCER)
  • BMS-UNICANCER-PACS-08/0610 (Other Identifier: UNICANCER)
  • AMGEN-UNICANCER-PACS-08/0610 (Other Identifier: UNICANCER)

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

Unicancer will share de-identified individual data that underlie the results reported. A decision concerning the sharing of other study documents, including protocol and statistical analysis plan will be examined upon request.

IPD Sharing Time Frame

Unicancer will consider access to study data upon written detailed request sent to Unicancer, from 6 months until 5 years after publication of summary data.

IPD Sharing Access Criteria

The data shared will be limit to that required for independent mandated verification of the published results, the applicant will need authorization from Unicancer for personal access, and data will only be transferred after signing of a data access agreement.

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.

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings