OUTCOMES OF THE SPANISH COHORT OF EARLY ACCESS TO PERTUZUMAB AND TRASTUZUMAB EMTANSINE (KNOWHER STUDY)

Study identification

• EU PAS number:
  EUPAS17462
• Study ID:
  17463
• Official title and acronym:
  OUTCOMES OF THE SPANISH COHORT OF EARLY ACCESS TO PERTUZUMAB AND TRASTUZUMAB EMTANSINE (KNOWHER STUDY)
• DARWIN EU® study:
  No
• Study countries:
  Spain
• Study description:
  Currently, four targeted anti-HER2 agents are available in the EU for the treatment of advanced HER2+ breast cancer: trastuzumab (a humanized monoclonal antibody that targets subdomain IV of HER2), lapatinib (a HER1/HER2 dual tyrosine kinase inhibitor) and, more recently, pertuzumab (a humanized monoclonal antibody that targets domain II of HER2) and trastuzumab emtansine (an antibody-drug conjugate). Three of these agents have been approved in combination with chemotherapy: trastuzumab, lapatinib (also authorized in combination with trastuzumab), and pertuzumab. Trastuzumab emtansine (T-DM1) is the only targeted agent currently approved as monotherapy. The addition of pertuzumab (Perjeta®) to trastuzumab plus chemotherapy (docetaxel) in first line treatment of HER2-positive metastatic breast cancer obtains a significant and clinically relevant increase in median PFS of 6.1 months. Both Kadcyla® and Perjeta® were available under those special access systems. In order to be eligible for CU of Trastuzumab emtansine (T-DM1) or Pertuzumab, patients had to meet the some prespecified criteria. After the EU approval, oncologists could prescribe the product to specific patients through the Early Access Program, provided that the local or regional responsible people accept payment.In order to evaluate the effectiveness and safety of Trastuzumab emtansine (T-DM1) and Pertuzumab in HER2-positive metastatic breast cancer under real-world disease conditions, is proposed a retrospective observational cohort non-comparative study / registry in Spain.
• Study status:
  Finalised

Research institutions and networks

Institutions

Puerta de Hierro-Majadahonda University Hospital

Clinical Pharmacology Service, Puerta de Hierro-Majadahonda University Hospital (HUPHM)

Spain

Clinical Pharmacology Department, Area del Medicament, Hospital Clínic de Barcelona

Spain

Study timelines

Date when funding contract was signed

Planned: 01/12/2016

Actual: 01/12/2016

Study start date

Planned: 03/04/2017

Actual: 30/01/2017

Data analysis start date

Planned: 03/07/2017

Actual: 30/01/2017

Date of final study report

Planned: 31/10/2017

Actual: 30/01/2017

Sources of funding

Pharmaceutical company and other private sector 

More details on funding

Roche Farma, S.A

Regulatory

• Was the study required by a regulatory body?:
  No
• Is the study required by a Risk Management Plan (RMP)?:
  Not applicable

Other study registration identification numbers and links

ClinicalTrials.gov Identifier: NCT03025711 https://clinicaltrials.gov/ct2/show/NCT03025711?term=NCT03025711&rank=1