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

NCT01777958 | Completed

• 1 other identifier: ML28750
• Study Type: observational
• Target: 135
• Locations: 1 country
• Sites: 1

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.

Conditions

Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Median progression-free survival in routine clinical practice

  approximately 7.5 years

Secondary Outcomes (4)

• 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

Study Arms (1)

Cohort

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• 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

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Hoffmann-La Roche: lead

Study Sites (1)

AGAPLESION Markus-Krankenhaus

Frankfurt, 60431, Germany

Location

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Clinical Trials

  Hoffmann-La Roche

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 25, 2013
• First Posted: January 29, 2013
• Study Start: June 14, 2013
• Primary Completion: November 25, 2020
• Study Completion: November 25, 2020
• Last Updated: December 14, 2020

Record last verified: 2020-12

Locations

DE (1)