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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.
Information provided by (Responsible Party):
Hoffmann-La Roche Identifier:
First received: January 25, 2013
Last updated: March 21, 2017
Last verified: March 2017
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.

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)


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

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
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Please refer to this study by its identifier: NCT01777958

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

Responsible Party: Hoffmann-La Roche Identifier: NCT01777958     History of Changes
Other Study ID Numbers: ML28750
Study First Received: January 25, 2013
Last Updated: March 21, 2017

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Breast Diseases
Skin Diseases
Antineoplastic Agents processed this record on May 25, 2017