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CompletedNCT01777958Updated Dec 14, 2020

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

An observational study in Breast Cancer, sponsored by Hoffmann-La Roche. Completed at 1 site in Germany. Open to female participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2020-12-14.

Sponsored by Hoffmann-La Roche · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
135
Ages
18 Years and older
Sex
Female
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Study 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.

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Conditions studied

  • Breast Cancer

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In context

Breast Neoplasms

12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.

This study's enrollment of 135 is below the median of 184 across 2,642 observational studies indexed under Breast Neoplasms.

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Lead sponsor

Hoffmann-La Roche is the lead sponsor of 2,061 studies on the registry; 85 are open to participants now.

Of its 319 completed or terminated interventional studies of FDA-regulated products, 239 (75%) have results posted.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
18 Years and older
Sexes eligible
Female
Accepts healthy volunteers
No
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

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

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
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Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
135 participants (actual)

Groups and cohorts

  • Cohort
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What researchers measure

Primary outcomes

  1. Median progression-free survival in routine clinical practice

    Time frame: approximately 7.5 years

Secondary outcomes

  1. Dosage/schedule: Initiation/duration/modification/discontinuation of Perjeta administration

    Time frame: approximately 7.5 years

  2. Clinical/demographic patients characteristics at initiation of treatment

    Time frame: approximately 7.5 years

  3. Safety: Incidence of adverse events

    Time frame: approximately 7.5 years

  4. Patient reported outcome: Quality of life (FACT B questionnaire)

    Time frame: approximately 7.5 years

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Study locations

1 site
  • AGAPLESION Markus-Krankenhaus
    Frankfurt, 60431, Germany
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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Dec 14, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT01777958
Lead sponsor
Hoffmann-La Roche
Responsible party
Sponsor
First posted
Jan 29, 2013
Start date
Jun 14, 2013
Primary completion
Nov 25, 2020
Completion
Nov 25, 2020
Last update
Dec 14, 2020

Study contacts

Clinical Trials
study director · Hoffmann-La Roche
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Dec 2020. You cannot join it, but the record below documents what was studied.

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