An Observational Study of the Mean Duration of Herceptin (Trastuzumab) Treatment in Patients With Early or Metastatic HER2-positive Breast Cancer (HERODOT)
This study is ongoing, but not recruiting participants.
Sponsor:
Hoffmann-La Roche
Information provided by (Responsible Party):
Hoffmann-La Roche
ClinicalTrials.gov Identifier:
NCT01187381
First received: August 20, 2010
Last updated: October 10, 2012
Last verified: October 2012
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This single arm observational study will assess the duration and safety of treatment with Herceptin (trastuzumab) in routine clinical practice in patients with early or metastatic HER2-positive breast cancer. Data will be collected from female patients treated with Herceptin according to the Summary of Product Characteristics and local protocols. Duration of observation for each patient is from therapy initiation until permanent discontinuation for any cause.
Condition |
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Breast Cancer |
Study Type: | Observational |
Study Design: | Observational Model: Cohort Time Perspective: Prospective |
Official Title: | Multicenter, Single-arm, Observational Study of Mean Duration of Trastuzumab Treatment for Early and Metastatic Breast Cancer in Romanian Population (HERODOT Study) |
Resource links provided by NLM:
Genetics Home Reference related topics:
breast cancer
Drug Information available for:
Trastuzumab
U.S. FDA Resources
Further study details as provided by Hoffmann-La Roche:
Primary Outcome Measures:
- Mean duration of Herceptin treatment in routine clinical practice, from start of treatment to permanent discontinuation [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- Reasons for discontinuation of Herceptin therapy [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Safety: Adverse events [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Therapeutic strategies before and during Herceptin treatment [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Progression-free survival in metastatic breast cancer [ Time Frame: 36 months ] [ Designated as safety issue: No ]
- Site of first disease progression during Herceptin therapy in metastatic setting [ Time Frame: 36 months ] [ Designated as safety issue: No ]
Enrollment: | 250 |
Study Start Date: | April 2010 |
Estimated Study Completion Date: | July 2013 |
Groups/Cohorts |
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Cohort |
![](https://webarchive.library.unt.edu/web/20121018190656im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
Ages Eligible for Study: | 18 Years and older |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | No |
Sampling Method: | Probability Sample |
Study Population
Female patients with early or metastatic HER2-positive breast cancer
Criteria
Inclusion Criteria:
- Female patients, >/= 18 years of age
- HER2-positive breast cancer
- Treated with Herceptin in accordance with Summary of Product Characteristics and local protocols
- Written informed consent to data collection
Exclusion Criteria:
- Any contraindication to Herceptin
- Clinically relevant cardiovascular disorder or disease
![](https://webarchive.library.unt.edu/web/20121018190656im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
![](https://webarchive.library.unt.edu/web/20121018190656im_/http://www.clinicaltrials.gov/ct2/html/images/frame/triangle.gif)
No publications provided
Responsible Party: | Hoffmann-La Roche |
ClinicalTrials.gov Identifier: | NCT01187381 History of Changes |
Other Study ID Numbers: | ML25235 |
Study First Received: | August 20, 2010 |
Last Updated: | October 10, 2012 |
Health Authority: | Romania: National Medicines Agency |
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 October 17, 2012