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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

135 participants

Study Classification

OBSERVATIONAL

Study Start Date

2013-06-14

Study Completion Date

2020-11-25

Brief Summary

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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.

Detailed Description

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Conditions

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Breast Cancer

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Cohort

No interventions assigned to this group

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Clinical Trials

Role: STUDY_DIRECTOR

Hoffmann-La Roche

Locations

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AGAPLESION Markus-Krankenhaus

Frankfurt, , Germany

Site Status

Countries

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Germany

Other Identifiers

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ML28750

Identifier Type: -

Identifier Source: org_study_id