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

Breast Cancer Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01480674
• Other study ID #: ML23001
• Status: Completed
• Phase: N/A
• First received: August 18, 2011
• Last updated: January 27, 2016
• Start date: March 2011
• Est. completion date: November 2012

Study information

• Verified date: January 2016
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Health authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)
• Study type: Observational

Clinical 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 160
• Est. completion date: November 2012
• Est. primary completion date: November 2012
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Observational Model: Cohort

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Tumor Hormone Receptor Status of Participants Without Progression	The clinical and tumor characteristics including Human Epidermal growth factor Receptor 2 (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.	Up to 3 years	No
Primary	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	Up to 3 years	No
Secondary	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.	Up to 12 years	No
Secondary	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.	Up to 12 years	No
Secondary	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.	Up to 12 years	No
Secondary	Dosage Schedule of Herceptin Treatment	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	No
Secondary	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.	Up to 12 years	No
Secondary	Incidences of 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.	Up to 1 year	No
Secondary	The Duration of Treatment of Trastuzumab	Total treatment duration and duration of the first line of treatment is reported.	Up to 1 Year	No