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NCT Number: NCT01480674

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 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.

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Key information

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Clinique Du Docteur Calabet; Cromg, Agen, France

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Trastuzumab

Drug

Primary outcomes

  1. 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.

  2. 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

Secondary outcomes

  1. Progression-free Survival

    Time frame: 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.

  2. Time to Progression

    Time frame: 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.

  3. Overall Survival

    Time frame: 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.

  4. Dosage Schedule of Herceptin Treatment

    Time frame: 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.

  5. Number of Participants With Antineoplastic Treatment in Combination With Trastuzumab and After Discontinuation of Trastuzumab Treatment

    Time frame: Up to 12 years

    Antineoplastic treatment given in combination with and after discontinuation (Aft. Dis) of herceptin treatment included chemotherapy and hormonotherapy.

  6. Number of Participants With Any Adverse Events and Serious Adverse Events

    Time frame: 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.

  7. The Duration of Treatment of Trastuzumab

    Time frame: Up to 1 Year

    Total treatment duration and duration of the first line of treatment is reported.

Sponsors and collaborators

Lead sponsor

Hoffmann-La Roche

Industry

Registry information

Official study 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

Important dates

Study start
2011
Primary completion
2012
Study completion
2012
First posted
Nov 29, 2011
Registry last updated
Aug 16, 2017

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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