An Observational Study of Patients With HER2-Positive Metastatic or Locally Advanced Breast Cancer Treated With Herceptin (Trastuzumab) in 1st Line and Without Progression For 3 Years

July 7, 2017 updated by: Hoffmann-La Roche

A Retrospective Study to Characterize Patients With HER2-positive Metastatic or Locally Advanced Breast Cancer, Treated by Herceptin® as 1st Line-therapy and Without Progression for at Least 3 Years Followed by a 1-year Prospective Study for Patients Still Alive

This observational study will characterize retrospectively patients with HER2-positive metastatic or locally advanced breast cancer who had received treatment with Herceptin (trastuzumab) in 1st line and who were without progression for at least three years. Patients will be followed prospectively for one year.

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.

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.
Observational

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.
160

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
      • Agen, France, 47000
        • Clinique Du Docteur Calabet; Cromg
      • Aix En Provence, France, 13616
        • C.H. Du Pays D'aix En Provence Service du Dr Blanc
      • Aix En Provence, France, 13617
        • Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
      • Ajaccio, France, 20176
        • Chd Castelluccio; Oncologie
      • Amiens, France, 80090
        • Clinique De L Europe; Radiotherapie Chimiotherapie
      • Amiens, France, 80090
        • Clinique De L Europe; Pmsi
      • Arras, France, 62012
        • HOP Prive Arras Les Bonnettes; Chimiotherapie
      • Aubervilliers, France, 93308
        • Hopital Europeen La Roseraie;Radiotherapie
      • Auxerre, France, 89000
        • Polyclinique Sainte Marguerite; Chimiotherapie
      • Beziers, France, 34535
        • Clinique Champeau Mediterranee; Radiotherapie Oncologie
      • Bordeaux, France, 33077
        • Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
      • Bordeaux, France, 33075
        • Hopital Saint Andre; Oncologie 2
      • Bourg En Bresse, France, 01012
        • Centre Hospitalier Fleyriat; Oncologie/Hematologie
      • Brest, France, 29609
        • Hopital Augustin Morvan; Hopital De Jour
      • Brive La Gaillarde, France, 19312
        • Ch De Brive La Gaillarde; Radiotherapie Oncologie
      • Caen, France, 14076
        • Centre Francois Baclesse; Comite Sein
      • Carcassonne, France, 11890
        • Ch Antoine Gayraud; Oncologie
      • Carcassonne, France
        • Clinique Montreal; Chimiotherapie
      • Chalon Sur Saone, France, 71321
        • Ch William Morey; Medecine 1
      • Clermont Ferrand, France, 63011
        • Centre Jean Perrin; Hopital De Jour
      • Clermont Ferrand, France, 63050
        • Pole Sante Republique;Oncologie Hematologie
      • DAX, France, 40107
        • Ch De Dax; Radiotherapie Oncologie
      • Dechy, France, 59187
        • Centre Leonard De Vinci;Chimiotherapie
      • Dijon, France, 21079
        • Centre Georges Francois Leclerc; Oncologie 3
      • Guilherand Granges, France, 07500
        • Hopital Prive Drome Ardeche; Chir 2A 2B
      • Hyeres, France, 83400
        • Clinique de L' Esperance; Oncologie
      • La Chaussee St Victor, France, 41260
        • Polyclinique de Blois; Chimiotherapie Ambulatoire
      • La Roche Sur Yon, France, 85925
        • CH Dptal Les Oudairies; Hematologie Oncologie
      • La Tronche, France, 38700
        • Hopital Albert Michallon; Oncologie
      • Lille, France, 59003
        • Polyclinique Du Bois; Oncologie
      • Lille, France, 59000
        • Polyclinique Du Bois; Centre Bourgogne
      • Longjumeau, France, 91161
        • Ch De Longjumeau; Hopital De Jour Et Semaine
      • Lormont, France, 33310
        • Clinique Des 4 Pavillons; Chimiotherapie
      • Lyon, France, 69373
        • Centre Leon Berard; Departement Oncologie Medicale
      • Lyon, France, 69437
        • Hopital Edouard Herriot; Pavillon F Rhumatologie
      • Lyon, France, 69400
        • Polyclinique Du Beaujolais; Chimiotherapie
      • Macon, France, 71000
        • Polyclinique Du Val De Saone; Chimiotherapie
      • Marseille, France, 13285
        • Hôpital Saint Joseph; Oncologie Medicale
      • Montelimar, France, 26216
        • Ch De Montelimar; Radiotherapie
      • Montpellier, France, 34070
        • Clinique Clementville; Hopital De Jour
      • Montpellier, France, 34967
        • Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
      • Mougins, France, 06250
        • Centre Azureen De Cancerologie; Cons externes
      • Mulhouse, France, 68070
        • Hopital Emile Muller; Oncologie Radiotherapie
      • Nancy, France, 54100
        • Centre D'Oncologie de Gentilly; Oncology
      • Nancy, France, 54100
        • Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
      • Narbonne, France, 11108
        • Clinique Des Genets; Radiotherapie
      • Neuilly Sur Seine, France, 92200
        • Clinique Henry Hartmann; Oncologie
      • Nice, France, 06189
        • Centre Antoine Lacassagne; Hopital De Jour A2
      • Nimes, France, 30900
        • Polyclinique Kenval ; Radiotherapie Oncologie
      • Nimes, France, 30029
        • Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie
      • Osny, France, 95520
        • Clinique sainte marie; chimiotherapie ambulatoire
      • Paris, France, 75970
        • HOPITAL TENON; Cancerologie Medicale
      • Paris, France, 75475
        • Hopital Saint Louis; Oncologie Medicale
      • Paris, France, 75571
        • Hopital Des Diaconesses; Hopital De Jour
      • Paris, France, 75651
        • Ch Pitie Salpetriere; Oncologie Medicale
      • Perigueux, France, 24000
        • Clinique Francheville; Radiotherapie
      • Pierre Benite, France, 69495
        • Ch Lyon Sud; Onco Secteur Jules Courmont
      • Pierre Benite, France, 69495
        • Ch Lyon Sud; Hemato Secteur Jules Courmont
      • Pithiviers, France, 45307
        • Ch De Pithiviers; Consult Externes
      • Reims, France, 51056
        • Institut Jean Godinot; Pavillon Rubis
      • Reims, France, 51057
        • Polyclinique De Courlancy; Chimiotherapie Ambulatoire
      • Rennes, France, 35042
        • Centre Eugene Marquis; Unite Huguenin
      • Rouen, France, 76044
        • Clinique Saint Hilaire; Sce Chimiotherapie
      • Saint Gregoire, France, 35768
        • Chp Saint Gregoire; Cancerologie Radiotherapie
      • Saint Herblain, France, 44805
        • Ico Rene Gauducheau; Oncologie
      • Saint Jean, France, 31240
        • Clinique de L'Union; Oncologie
      • Saint Nazaire, France, 44600
        • Centre Radiotherapie Etienne Dolet
      • Saint Quentin, France, 02321
        • Ch De Saint Quentin; Medecine B10
      • Senlis, France, 60309
        • CH De Senlis; Medecine 2
      • Soissons, France, 02209
        • Ch De Soissons; Medecine Ambulatoire
      • St Priest En Jarez, France, 42271
        • Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
      • Toulouse, France, 31059
        • Institut Claudius Regaud; Departement Oncologie Medicale
      • Toulouse, France, 31076
        • Clinique Pasteur; Oncologie Medicale
      • Toulouse, France
        • Chevelle Christian; Centre De Radiotherapie
      • Vandoeuvre Les Nancy, France, 54511
        • Centre Alexis Vautrin; Oncologie Medicale
      • Verdun, France, 55107
        • Hopital Saint Nicolas; Pneumologie
      • Villejuif, France, 94805
        • Institut Gustave Roussy; Departement Oncologie Medicale
      • Villejuif, France, 94805
        • Institut Gustave Roussy; Comite 5

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

Genders Eligible for Study

Female

Sampling Method

Probability Sample

Study Population

Patients with HER2-positive metastatic breast cancer or locally advanced breast cancer whose systemic treatment included Herceptin as 1st line therapy, and who were without progression for at least 3 years after beginning Herceptin

Description

Inclusion Criteria:

  • Female patients, >/= 18 years of age
  • HER2-positive metastatic breast cancer or locally advanced breast cancer
  • Systemic treatment included Herceptin as 1st line therapy
  • Without progression for at least 3 years after the beginning of Herceptin treatment
  • Alive or not alive and treated or not treated with Herceptin at the time of inclusion

Exclusion Criteria:

  • Disease progression <3 years after beginning 1st-line therapy with Herceptin

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

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
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.
Trastuzumab
Eligible participants with human epidermal growth factor receptor 2 (HER2)-positive metastatic or locally advanced breast cancer, who were treated with trastuzumab as a first-line therapy and were progression-free for at least 3 years after treatment initiation, were included and were followed for one year.
Drug: Trastuzumab

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
Tumor Hormone Receptor Status of Participants Without Progression
Time Frame: Up to 3 years
The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of metastatic breast cancer participants are analysed which are important factors which impact on Progression Free Survival.
Up to 3 years
Percentage of Participants With Prevalence of Bone Metastases Without Progression for at Least 3 Years After the Beginning of 1st Line Herceptin Treatment
Time Frame: Up to 3 years
Bone metastasis occurs when cancer cells spread from their original site to a bone. Percentage of participants with prevalence of bone metastases without progression were reported
Up to 3 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
Progression-free Survival
Time Frame: Up to 12 years
The Progression-free survival (PFS) was defined as the time between the treatment start date (date of first trastuzumab infusion during the metastatic period) and the date of the first progressive disease or death from any cause. The method of assessment of disease progression was not outlined within the protocol, this was completed by each investigator in line with routine practice.
Up to 12 years
Time to Progression
Time Frame: Up to 12 years
The Time to progression (TTP) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the date of the first progressive disease.
Up to 12 years
Overall Survival
Time Frame: Up to 12 years
The overall survival (OS) was defined as the time between the treatment start date (date of the first trastuzumab infusion during the metastatic period) and the death from any cause.
Up to 12 years
Dosage Schedule of Herceptin Treatment
Time Frame: Up to 12 years
Participants who received trastuzumab are reported in the below table. The regimen of trastuzumab in first line treatment is presented as in frequency 1 infusion (inf) per week (W) and dose per infusion as mg/kg.
Up to 12 years
Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment
Time Frame: Up to 12 years
Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.
Up to 12 years
Number of Participants With Any Adverse Events and Serious Adverse Events
Time Frame: Up to 1 year
An adverse event (AE) was defined as any untoward medical occurrence that occurred during the course of the trial after study treatment had started. An adverse event was therefore any unfavourable and unintended sign, symptom, or disease temporally associated with the use of study drug, whether or not considered related to the study drug. A Serious Adverse Event (SAE) is any untoward medical occurrence that at any dose results in death, are life threatening, requires hospitalization or prolongation of hospitalization or results in disability/incapacity, and congenital anomaly/birth defect. The data was reported for prospective period.
Up to 1 year
The Duration of Treatment of Trastuzumab
Time Frame: Up to 1 Year
Total treatment duration and duration of the first line of treatment is reported.
Up to 1 Year

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.
Hoffmann-La Roche

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.
March 28, 2011

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.
November 16, 2012

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.
November 16, 2012

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).
August 18, 2011

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.
November 28, 2011

First Posted (Estimate)

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.
November 29, 2011

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.
August 16, 2017

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.
July 7, 2017

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.
June 1, 2017

More Information

Terms related to this study

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.
  • ML23001

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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