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

Breast Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01777958
• Other study ID #: ML28750
• Status: Completed
• Start date: June 14, 2013
• Est. completion date: November 25, 2020

Study information

• Verified date: December 2020
• Source: Hoffmann-La Roche
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 135
• Est. completion date: November 25, 2020
• Est. primary completion date: November 25, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Locations

Country	Name	City	State
Germany	AGAPLESION Markus-Krankenhaus	Frankfurt

Sponsors (1)

Lead Sponsor	Collaborator
Hoffmann-La Roche

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Median progression-free survival in routine clinical practice		approximately 7.5 years
Secondary	Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration		approximately 7.5 years
Secondary	Clinical/demographic patients characteristics at initiation of treatment		approximately 7.5 years
Secondary	Safety: Incidence of adverse events		approximately 7.5 years
Secondary	Patient reported outcome: Quality of life (FACT B questionnaire)		approximately 7.5 years