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Information sheet on the clinical trial - PRO-B

Main indication

Breast cancer

 

Study name (study type)

PRO B

 

Study sponsor

The study is funded by the Innovation Committee of the Joint Federal Committee (Grant Number: 01NVF19013).

 

Registration number

DRKS-ID: DRKS00024015 / UTN U11111-1263-4946

 

FOR RAPID READERS:

This study is for patients with metastatic blood cancer. Treatment data and questionnaires will be collected from the patients. The study is an observational study and has no influence on the treatment method prescribed by the physician

 

DETAILED INFORMATION:

PRO-B is a prospective, multicenter, randomized, two-arm intervention study aimed at implementing and evaluating PRO-B measurements in patients with metastatic breast cancer. Patients are assigned to two different groups (control arm and intervention arm). In the control arm, patients are contacted every three months for a PRO measurement, and in the intervention arm, weekly. If the values deteriorate, the breast cancer center is notified. The total duration of this study is 36 months. 

 

Study Title

PRO-B - New Approaches to Care for Metastatic Breast Cancer

 

Which conditions are being studied?

Metastatic breast cancer

 

Are specific subgroups of patients with one of the mentioned conditions being treated?

No

 

Background on the study medication

None

 

Study protocol

In the PRO-B study, patients agree to participate in an online survey once a week. 

 

Inclusion criteria

  • Female
  • Legally insured with one of the following health insurance providers: BARMER, DAK Gesundheit, BKK VBU (other health insurance providers may be accepted upon request)
  • Diagnosis: metastatic breast cancer
  • Treatment at a participating breast cancer center
  • Age 18 or older
  • Receiving drug therapy based on the diagnosis
  • Life expectancy of more than 3 months at the time of study enrollment, ECOG 0–2
  • Access to the internet and willingness to participate in a weekly online survey

 

Exclusion criteria

  • No active tumor therapy

 

Your contacts: Investigators at the center and contact information

Dr. Andriana Haus

Email: haus@~@gp-ruesselsheim.de

Phone: 06142 88-1223

 

Staff members responsible for the study clinic

Heike Borchert (Study Coordinator)

Email: borchert@~@gp-ruesselsheim.de

Phone: 06142 88-1032

Clinical studies and medical documentation