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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01777958

Enrollment

135

Registered

2013-01-29

Start date

2013-06-14

Completion date

2020-11-25

Last updated

2020-12-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Breast Cancer

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

FEMALE

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame
Median progression-free survival in routine clinical practice	approximately 7.5 years

Secondary

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

Countries

Germany

Outcome results