Breast CancerNCT01480674
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
An observational study of Breast Cancer, run by Hoffmann-La Roche at 78 sites in France.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Breast Cancer
- What is being tested?
- Trastuzumab
- How many people
- 160 participants
- Where
- 78 sitesFrance
- Study dates
- 28 Mar 2011to 16 Nov 2012
- Phase
- Observational
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- Disease progression <3 years after beginning 1st-line therapy with Herceptin
Trial locations and contacts
78 sites in 1 country.
78 sites in 1 country
France78 sites
Clinique Du Docteur Calabet; Cromg
Agen, 47000
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix-en-Provence, 13616
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix-en-Provence, 13617
Chd Castelluccio; Oncologie
Ajaccio, 20176
Clinique De L Europe; Pmsi
Amiens, 80090
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, 80090
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, 62012
Hopital Europeen La Roseraie;Radiotherapie
Aubervilliers, 93308
Polyclinique Sainte Marguerite; Chimiotherapie
Auxerre, 89000
Clinique Champeau Mediterranee; Radiotherapie Oncologie
Béziers, 34535
Hopital Saint Andre; Oncologie 2
Bordeaux, 33075
Polyclinique Bordeaux Nord Aquitaine; Chimiotherapie Radiotherapie
Bordeaux, 33077
Centre Hospitalier Fleyriat; Oncologie/Hematologie
Bourg-en-Bresse, 01012
Hopital Augustin Morvan; Hopital De Jour
Brest, 29609
Ch De Brive La Gaillarde; Radiotherapie Oncologie
Brive-la-Gaillarde, 19312
Centre Francois Baclesse; Comite Sein
Caen, 14076
Ch Antoine Gayraud; Oncologie
Carcassonne, 11890
Clinique Montreal; Chimiotherapie
Carcassonne
Ch William Morey; Medecine 1
Chalon-sur-Saône, 71321
Centre Jean Perrin; Hopital De Jour
Clermont-Ferrand, 63011
Pole Sante Republique;Oncologie Hematologie
Clermont-Ferrand, 63050
Ch De Dax; Radiotherapie Oncologie
Dax, 40107
Centre Leonard De Vinci;Chimiotherapie
Dechy, 59187
Centre Georges Francois Leclerc; Oncologie 3
Dijon, 21079
Hopital Prive Drome Ardeche; Chir 2A 2B
Guilherand-Granges, 07500
Clinique de L' Esperance; Oncologie
Hyères, 83400
Polyclinique de Blois; Chimiotherapie Ambulatoire
La Chaussée-Saint-Victor, 41260
CH Dptal Les Oudairies; Hematologie Oncologie
La Roche-sur-Yon, 85925
Hopital Albert Michallon; Oncologie
La Tronche, 38700
Polyclinique Du Bois; Centre Bourgogne
Lille, 59000
Polyclinique Du Bois; Oncologie
Lille, 59003
Ch De Longjumeau; Hopital De Jour Et Semaine
Longjumeau, 91161
Clinique Des 4 Pavillons; Chimiotherapie
Lormont, 33310
Centre Leon Berard; Departement Oncologie Medicale
Lyon, 69373
Polyclinique Du Beaujolais; Chimiotherapie
Lyon, 69400
Hopital Edouard Herriot; Pavillon F Rhumatologie
Lyon, 69437
Polyclinique Du Val De Saone; Chimiotherapie
Mâcon, 71000
Hôpital Saint Joseph; Oncologie Medicale
Marseille, 13285
Ch De Montelimar; Radiotherapie
Montélimar, 26216
Clinique Clementville; Hopital De Jour
Montpellier, 34070
Polyclinique Saint Roch; Hop Jour Chimio Radiotherapie
Montpellier, 34967
Centre Azureen De Cancerologie; Cons externes
Mougins, 06250
Hopital Emile Muller; Oncologie Radiotherapie
Mulhouse, 68070
Centre D'Oncologie de Gentilly; Oncology
Nancy, 54100
Polyclinique Gentilly; CHIMIOTHERAPIE AMBULATOIRE
Nancy, 54100
Clinique Des Genets; Radiotherapie
Narbonne, 11108
Clinique Henry Hartmann; Oncologie
Neuilly-sur-Seine, 92200
Centre Antoine Lacassagne; Hopital De Jour A2
Nice, 06189
Centre Hospitalier Uni Ire Caremeau; Radiotherapie & Oncologie
Nîmes, 30029
Polyclinique Kenval ; Radiotherapie Oncologie
Nîmes, 30900
Clinique sainte marie; chimiotherapie ambulatoire
Osny, 95520
Hopital Saint Louis; Oncologie Medicale
Paris, 75475
Hopital Des Diaconesses; Hopital De Jour
Paris, 75571
Ch Pitie Salpetriere; Oncologie Medicale
Paris, 75651
HOPITAL TENON; Cancerologie Medicale
Paris, 75970
Clinique Francheville; Radiotherapie
Périgueux, 24000
Ch Lyon Sud; Hemato Secteur Jules Courmont
Pierre-Bénite, 69495
Ch Lyon Sud; Onco Secteur Jules Courmont
Pierre-Bénite, 69495
Ch De Pithiviers; Consult Externes
Pithiviers, 45307
Institut Jean Godinot; Pavillon Rubis
Reims, 51056
Polyclinique De Courlancy; Chimiotherapie Ambulatoire
Reims, 51057
Centre Eugene Marquis; Unite Huguenin
Rennes, 35042
Clinique Saint Hilaire; Sce Chimiotherapie
Rouen, 76044
Chp Saint Gregoire; Cancerologie Radiotherapie
Saint-Grégoire, 35768
Ico Rene Gauducheau; Oncologie
Saint-Herblain, 44805
Clinique de L'Union; Oncologie
Saint-Jean, 31240
Centre Radiotherapie Etienne Dolet
Saint-Nazaire, 44600
Institut De Cancerologie De La Loire; Consult Oncologie Niveau 0
Saint-Priest-en-Jarez, 42271
Ch De Saint Quentin; Medecine B10
Saint-Quentin, 02321
CH De Senlis; Medecine 2
Senlis, 60309
Ch De Soissons; Medecine Ambulatoire
Soissons, 02209
Institut Claudius Regaud; Departement Oncologie Medicale
Toulouse, 31059
Clinique Pasteur; Oncologie Medicale
Toulouse, 31076
Chevelle Christian; Centre De Radiotherapie
Toulouse
Centre Alexis Vautrin; Oncologie Medicale
Vandœuvre-lès-Nancy, 54511
Hopital Saint Nicolas; Pneumologie
Verdun, 55107
Institut Gustave Roussy; Comite 5
Villejuif, 94805
Institut Gustave Roussy; Departement Oncologie Medicale
Villejuif, 94805
About this study
Official title: 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.
- Conditions
- Breast Cancer
- Being tested
- Trastuzumab
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TrastuzumabDrug
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Trastuzumab |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tumor Hormone Receptor Status of Participants Without Progression
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.
Measured: 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
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
Measured: Up to 3 years
Secondary outcomes (7)
Progression-free Survival
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.
Measured: Up to 12 years
Time to Progression
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.
Measured: Up to 12 years
Overall Survival
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.
Measured: Up to 12 years
Dosage Schedule of Herceptin Treatment
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.
Measured: Up to 12 years
Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment
Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.
Measured: Up to 12 years
Number of Participants With Any Adverse Events and Serious Adverse Events
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.
Measured: Up to 1 year
The Duration of Treatment of Trastuzumab
Total treatment duration and duration of the first line of treatment is reported.
Measured: Up to 1 Year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Nov 2011 (estimated)
- Study start28 Mar 2011
- Primary completion16 Nov 2012
- Study completion16 Nov 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Breast CancerStudies of the same condition, open and under way.
- More trials run by Hoffmann-La RocheThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Other
- Enrolment
- 160 participants (actual)
Sponsor and investigators
- Lead sponsor
- Hoffmann-La Roche
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Clinical Trials, Study director, Hoffmann-La Roche
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01480674
- Sponsor's protocol ID
- ML23001
- Status last verified
- Jun 2017
- First submitted
- 18 Aug 2011
- Last updated
- 16 Aug 2017
- Results posted
- Yes, on ClinicalTrials.gov
Study at a glance
From the registry record, last updated by the sponsor on 16 Aug 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT01480674
- Acronym / sponsor ID
- ML23001
- Conditions
- Breast Cancer
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 160 participants (actual)
- Lead sponsor
- Hoffmann-La RocheIndustry (pharma, biotech, devices)
- Study start
- 28 Mar 2011 (actual)
- Primary completion
- 16 Nov 2012 (actual)
- Study completion
- 16 Nov 2012 (actual)
- First posted
- 29 Nov 2011 (estimated)
- Results
- Posted 24 Feb 2016
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Other
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Trastuzumab | – | Drug: TrastuzumabEligible 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (1 listed)
- Disease progression <3 years after beginning 1st-line therapy with Herceptin
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Trastuzumab | Drug | Trastuzumab |
Primary outcome
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.
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
7 secondary outcomes
Progression-free Survival
Time frame: Up to 12 years
Time to Progression
Time frame: Up to 12 years
Overall Survival
Time frame: Up to 12 years
Dosage Schedule of Herceptin Treatment
Time frame: 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
Number of Participants With Any Adverse Events and Serious Adverse Events
Time frame: Up to 1 year
The Duration of Treatment of Trastuzumab
Time frame: Up to 1 Year
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 Aug 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Clinical Trials study director
Hoffmann-La Roche
78 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Breast Cancer, run by Hoffmann-La Roche at 78 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 5 inclusion and 1 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: finished, as of the sponsor's last update on 16 Aug 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 78 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.
Are results available for this study?
Yes. Results are posted in the registry (first posted 24 Feb 2016). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Tumor Hormone Receptor Status of Participants Without Progression (time frame: Up to 3 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 16 Aug 2017.