Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006089

Trial Description

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Title

Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

This observational study will evaluate the efficacy, safety and patient reported quality of
life of palliative first-line Perjeta (pertuzumab) in combination with Herceptin
(trastuzumab) in patients with HER2-positive advanced breast cancer (metastatic or locally
recurrent, inoperable) who relapsed after completed adjuvant Herceptin therapy.
Additionally, information on selection criteria of breast cancer patients treated first-line
with Perjeta, Herceptin and chemotherapy and their treatment duration will be collected and
analyzed. Data will be collected from eligible patients for up to 20 months of treatment and
24 months of follow-up.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006089
  •   2014/04/25
  •   2013/01/25
  •   no
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Secondary IDs

  •   NCT01777958  (ClinicalTrials.gov)
  •   ML28750  (Hoffmann-La Roche)
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

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Characteristics

  •   Non-interventional
  •   Observational study
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  •   N/A
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Primary Outcome

- Median progression-free survival in routine clinical practice; time frame: approximately 7.5 years

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Secondary Outcome

- Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration; time frame: approximately 7.5 years
- Clinical/demographic patients characteristics at initiation of treatment; time frame: approximately 7.5 years
- Safety: Incidence of adverse events; time frame: approximately 7.5 years
- Patient reported outcome: Quality of life (FACT B questionnaire); time frame: approximately 7.5 years

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2013/06/30
  •   478
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Inclusion Criteria

  •   Female
  •   18   Years
  •   no maximum age
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Additional Inclusion Criteria

- Female adult patients, >/= 18 years of age

- HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)
relapsing after completed adjuvant Herceptin therapy

- Indication for first-line treatment with Perjeta in combination with Herceptin and
chemotherapy according to the Summary of Product Characteristics

- Prior Herceptin therapy as systemic adjuvant treatment (postoperative treatment in a
potentially curable setting); additional upfront neoadjuvant Herceptin therapy is
allowed

- No prior chemotherapy and/or immunotherapy for advanced (metastatic or locally
recurrent, inoperable) HER2-positive breast cancer

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Exclusion Criteria

- Pregnant or breastfeeding women

- Contraindications to Perjeta, Herceptin or concomitant chemotherapy according to the
Summary of Product Characteristics

- No Herceptin treatment for early breast cancer in the adjuvant setting

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Addresses

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    • Hoffmann-La Roche
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    • Hoffmann-La Roche
    • Clinical Trials 
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    • Reference Study ID Number: ML28750 www.roche.com/about_roche/roche_worldwide.htm 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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Status

  •   Recruiting ongoing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   110
  •   2014/04/08
* This entry means the parameter is not applicable or has not been set.