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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 is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01480674
First received: August 18, 2011
Last updated: May 7, 2013
Last verified: May 2013
History of Changes
  Purpose

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
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
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:

Drug Information available for: Trastuzumab
U.S. FDA Resources

Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Tumor hormone receptor status (HER2/HR) of patients without progression for at least 3 years after the beginning of 1st line Herceptin treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]
  • Prevalence of bone metastases in patients without progression for at least 3 years after the beginning of 1st line Herceptin treatment [ Time Frame: 6 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Progression-free survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Time to progression [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Overall survival [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Dosage schedule/duration of Herceptin treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Antineoplastic treatment (drugs, dosage schedule, duration) in combination with and after discontinuation of Herceptin treatment [ Time Frame: 1 year ] [ Designated as safety issue: No ]
  • Safety: Incidence of adverse events [ Time Frame: 1 year ] [ Designated as safety issue: No ]

Biospecimen Retention:   None Retained

unknown


Enrollment: 159
Study Start Date: March 2011
Estimated Study Completion Date: June 2013
Estimated Primary Completion Date: June 2013 (Final data collection date for primary outcome measure)

  Eligibility

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

Criteria

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
Please refer to this study by its ClinicalTrials.gov identifier: NCT01480674

  Show 76 Study Locations
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

No publications provided

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01480674     History of Changes
Other Study ID Numbers: ML23001
Study First Received: August 18, 2011
Last Updated: May 7, 2013
Health Authority: France: Commission Nationale de l'Informatique et des Libertés (CNIL)

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
 Trastuzumab
Antineoplastic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013