Clinical trial NCT01777958: HELENA Study: An Observational Study of Perjeta (Pertuzumab) in First-Line Treatment in Patients With Her2-Positive Advanced Breast Cancer After Adjuvant Herceptin Therapy
Official title: Noninterventional Study - Advanced HER2-positive Breast Cancer (Metastatic or Locally Recurrent, Inoperable): First-Line Treatment With PERJETA After Adjuvant Herceptin Therapy (HELENA)
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Breast Cancer
Lead sponsor: Hoffmann-La Roche
Sponsor class: INDUSTRY
First posted: 2013-01-29
Enrollment: 135
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
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

Brief summary: 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.


Eligibility 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

Primary outcomes:
measure: Median progression-free survival in routine clinical practice
timeFrame: approximately 7.5 years
Secondary outcomes:
measure: Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration
timeFrame: approximately 7.5 years
measure: Clinical/demographic patients characteristics at initiation of treatment
timeFrame: approximately 7.5 years
measure: Safety: Incidence of adverse events
timeFrame: approximately 7.5 years
measure: Patient reported outcome: Quality of life (FACT B questionnaire)
timeFrame: approximately 7.5 years
Other outcomes:
Locations:
city: Frankfurt
country: Germany
facility: AGAPLESION Markus-Krankenhaus
Study officials:
affiliation: Hoffmann-La Roche
name: Clinical Trials
role: STUDY_DIRECTOR
References: