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HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy

This study is ongoing, but not recruiting participants.
Sponsor:
ClinicalTrials.gov Identifier:
NCT01777958
First Posted: January 29, 2013
Last Update Posted: December 13, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Hoffmann-La Roche
  Purpose
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.

Condition
Breast Cancer

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)

Resource links provided by NLM:


Further study details as provided by Hoffmann-La Roche:

Primary Outcome Measures:
  • Median progression-free survival in routine clinical practice [ Time Frame: approximately 7.5 years ]

Secondary Outcome Measures:
  • 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 ]

Enrollment: 135
Study Start Date: June 14, 2013
Estimated Study Completion Date: December 15, 2020
Estimated Primary Completion Date: December 15, 2020 (Final data collection date for primary outcome measure)

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Female patients with HER2-positive advanced breast cancer (metastatic or locally recurrent, inoperable)who relapsed after adjuvant Herceptin therapy, with indication for treatment with Perjeta in combination with Herceptin
Criteria

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

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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01777958


Locations
Germany
AGAPLESION Markus-Krankenhaus
Frankfurt, Germany, 60431
Sponsors and Collaborators
Hoffmann-La Roche
Investigators
Study Director: Clinical Trials Hoffmann-La Roche
  More Information

Responsible Party: Hoffmann-La Roche
ClinicalTrials.gov Identifier: NCT01777958     History of Changes
Other Study ID Numbers: ML28750
First Submitted: January 25, 2013
First Posted: January 29, 2013
Last Update Posted: December 13, 2017
Last Verified: December 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Pertuzumab
Trastuzumab
Antineoplastic Agents