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

Contact details

Avendaño-Sola Cristina

Primary lead investigator

Study timelines

Date when funding contract was signed

Planned:
Actual:

Study start date

Planned:
Actual:

Data analysis start date

Planned:
Actual:

Date of final study report

Planned:
Actual:
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