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 Type
OBSERVATIONAL
Enrollment
160
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.
Time frame: 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
Time frame: Up to 3 years
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 12 years
Dosage Schedule of Herceptin Treatment
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Clinique Du Docteur Calabet; Cromg
Agen, France
C.H. Du Pays D'aix En Provence Service du Dr Blanc
Aix-en-Provence, France
Poly Parc Rambot La Provencale; Chimiotherapie Ambulatoire
Aix-en-Provence, France
Chd Castelluccio; Oncologie
Ajaccio, France
Clinique De L Europe; Pmsi
Amiens, France
Clinique De L Europe; Radiotherapie Chimiotherapie
Amiens, France
HOP Prive Arras Les Bonnettes; Chimiotherapie
Arras, France
Hopital Europeen La Roseraie;Radiotherapie
Aubervilliers, France
Polyclinique Sainte Marguerite; Chimiotherapie
Auxerre, France
Clinique Champeau Mediterranee; Radiotherapie Oncologie
Béziers, France
...and 68 more locations
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.
Time frame: 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.
Time frame: 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.
Time frame: Up to 1 year
The Duration of Treatment of Trastuzumab
Total treatment duration and duration of the first line of treatment is reported.
Time frame: Up to 1 Year