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

Completed

• Conditions: Breast Cancer
• Interventions: Drug: Trastuzumab

• Registration Number: NCT01480674
• Lead Sponsor: Hoffmann-La Roche

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2011-03-28
• Study First Submitted: 2011-08-18
• Study First Submitted QC: 2011-11-28
• Study First Posted: 2011-11-29
• Primary Completion: 2012-11-16
• Study Completion: 2012-11-16
• Results First Submitted: 2016-01-27
• Results First Submitted QC: 2016-01-27
• Results First Posted: 2016-02-24
• Status Verified: 2017-06
• Last Update Submitted: 2017-07-07
• Last Update Posted: 2017-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 160

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 & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Trastuzumab	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.

Primary Outcome Measures

Name	Time	Method
Tumor Hormone Receptor Status of Participants Without Progression	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	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

Secondary Outcome Measures

Name	Time	Method
Overall Survival	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.
Progression-free Survival	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.
Time to Progression	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.
Dosage Schedule of Herceptin Treatment	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.
Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment	Up to 12 years	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	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.
The Duration of Treatment of Trastuzumab	Up to 1 Year	Total treatment duration and duration of the first line of treatment is reported.

Trial Locations

Locations (78)

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; 🇫🇷 Beziers, France

Scroll for more (68 remaining)