Clinical trial · Observational
Pertuzumab in First Line Treatment of HER2-positive Metastatic Breast Cancer Patients
Pertuzumab in First Line Treatment of HER2-positive Metastatic Breast Cancer Patients: A Cohort Study of Patients Treated Either With Docetaxel and Trastuzumab or Docetaxel, Trastuzumab and Pertuzumab
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
Despite the clear benefit of a combination therapy of pertuzumab plus trastuzumab plus docetaxel when compared with a combination therapy of trastuzumab and docetaxel the study populations of the CLEOPATRA trial might be slightly different from a patient population, in which pertuzumab, plus trastuzumab plus chemotherapy or trastuzumab plus chemotherapy are applied in routine clinical practice. This non-interventional approach aims to confirm the clinically relevant outcomes shown in the phase III CLEOPATRA study in patients with advanced HER2-positive breast cancer in routine practice. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician. Data on efficacy, safety, tolerability and quality of life will be documented for this purpose. Following the recommendations as laid down in guidelines for treatment of breast cancer, the quality of life of patients will be assessed on a regular basis.
Conditions
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Metastatic Breast Cancer | Malignant Breast Neoplasm | CURATED_BROADER | 0.78 |
Interventions
Interventions (0)
Data not yet available
Design
Arms and outcomes
Arms (2)
- label
- trastuzumab plus chemotherapy
- description
- Treatment with trastuzumab plus chemotherapie as first line therapy, administered intravenously/subcutaneously in a three weekly frequency. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician.
- label
- pertuzumab plus trastuzumab plus chemotherapy
- description
- Treatment with with pertuzumab plus trastuzumab plus chemotherapy as first line therapy, administered intravenously/subcutaneously in a three weekly frequency. Docetaxel is recommended as chemotherapy, however, any treatment choice or change in regimen is performed at the discretion of the treating physician.
Primary outcomes (1)
- measure
- progression free survival rate
- timeFrame
- At 12 months or month 36
- description
- The primary objective of this study is to assess the progression free survival rate at month 12 for both treatment cohorts in routine clinical practice treated with either pertuzumab plus trastuzumab plus docetaxel or trastuzumab plus docetaxel.
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 18 Years
- Maximum age
- 99 Years
Show eligibility criteria text
Inclusion Criteria: * Adult breast cancer patients (age ≥18 years) * Patients with metastatic or locally advanced, unresectable HER2-positive breast cancer proven by clinical measures (i.e. standard imaging) in first line treatment (Locally recurrent disease must not be amenable to resection with curative intent) * Patients who are eligible for treatment with trastuzumab plus chemotherapy or pertuzumab plus trastuzumab plus chemotherapy as first line therapy, administered intravenously in a three weekly frequency, according to each center's medical practice. The first line anti-HER2 treatment must not have started more than 28 days before study entry. * No prior chemotherapy or HER2-directed therapy for metastatic or locally advanced disease, prior therapy for early breast cancer (eBC) is allowed * Signed informed consent prior to onset of documentation. Exclusion Criteria: • Patients who are not eligible for observation due to severe comorbidities or unavailability according to the treating physician
References
Publications (0)
Data not yet available