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

This study has been completed.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: August 18, 2011
Last updated: April 5, 2016
Last verified: April 2016
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.

Condition Intervention
Breast Cancer
Drug: Trastuzumab

Study Type: Observational
Study Design: Observational Model: Cohort
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

Resource links provided by NLM:

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tumor Hormone Receptor Status of Participants Without Progression [ Time Frame: Up to 3 years ] [ Designated as safety issue: No ]
    The clinical and tumor characteristics including HER2 and Hormone Receptor (HR) status of MBC patients are analysed which are important factors which impact on Progression Free Survival. Here 'n' is equal to (=) number of participants analyzed at a particular time point.

  • 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 ] [ Designated as safety issue: No ]
    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

Secondary Outcome Measures:
  • Progression-free Survival [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    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.

  • Time to Progression [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    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.

  • Overall Survival [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    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.

  • Dosage Schedule of Herceptin Treatment [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    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.

  • Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment [ Time Frame: Up to 12 years ] [ Designated as safety issue: No ]
    Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.

  • Number of Participants With Any Adverse Events and Serious Adverse Events [ Time Frame: Up to 1 year ] [ Designated as safety issue: No ]
    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.

  • The Duration of Treatment of Trastuzumab [ Time Frame: Up to 1 Year ] [ Designated as safety issue: No ]
    Total treatment duration and duration of the first line of treatment is reported.

Biospecimen Retention:   None Retained

Enrollment: 160
Study Start Date: March 2011
Study Completion Date: November 2012
Primary Completion Date: November 2012 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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


Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

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
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01480674

  Hide Study Locations
Agen, France, 47000
Aix En Provence, France, 13616
Aix En Provence, France, 13617
Ajaccio, France, 20176
Amiens, France, 80090
Arras, France, 62012
Aubervilliers, France, 93308
Auxerre, France, 89000
Beziers, France, 34535
Bordeaux, France, 33075
Bordeaux, France, 33077
Bourg En Bresse, France, 01012
Brest, France, 29609
Brive La Gaillarde, France, 19312
Caen, France, 14076
Carcassonne, France, 11890
Carcassonne, France
Chalon Sur Saone, France, 71321
Clermont Ferrand, France, 63011
Clermont Ferrand, France, 63050
DAX, France, 40107
Dechy, France, 59187
Dijon, France, 21079
Guilherand Granges, France, 07500
Hyeres, France, 83400
La Chaussee St Victor, France, 41260
La Roche Sur Yon, France, 85925
La Tronche, France, 38700
Lille, France, 59003
Lille, France, 59000
Longjumeau, France, 91161
Lormont, France, 33310
Lyon, France, 69437
Lyon, France, 69373
Lyon, France, 69400
Macon, France, 71000
Marseille, France, 13285
Montelimar, France, 26216
Montpellier, France, 34070
Montpellier, France, 34967
Mougins, France, 06250
Mulhouse, France, 68070
Nancy, France, 54100
Narbonne, France, 11108
Neuilly Sur Seine, France, 92200
Nice, France, 06189
Nimes, France, 30029
Nimes, France, 30900
Osny, France, 95520
Paris, France, 75970
Paris, France, 75571
Paris, France, 75651
Paris, France, 75475
Perigueux, France, 24000
Pierre Benite, France, 69495
Pithiviers, France, 45307
Reims, France, 51056
Reims, France, 51057
Rennes, France, 35042
Rouen, France, 76044
Saint Gregoire, France, 35768
Saint Herblain, France, 44805
Saint Jean, France, 31240
Saint Nazaire, France, 44600
Saint Quentin, France, 02321
Senlis, France, 60309
Soissons, France, 02209
St Priest En Jarez, France, 42271
Toulouse, France, 31059
Toulouse, France, 31076
Toulouse, France
Vandoeuvre Les Nancy, France, 54511
Verdun, France, 55107
Villejuif, France, 94805
Sponsors and Collaborators
Hoffmann-La Roche
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche Identifier: NCT01480674     History of Changes
Other Study ID Numbers: ML23001 
Study First Received: August 18, 2011
Results First Received: January 27, 2016
Last Updated: April 5, 2016
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Breast Neoplasms
Breast Diseases
Neoplasms by Site
Skin Diseases
Antineoplastic Agents processed this record on May 30, 2016