NCT02095743

Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer

Phase II Randomised Study Comparing the Tolerance of PICC Line (Peripherally Inserted Central Catheter) and Implanted Port for Adjuvant Chemotherapy in HER2-negative Early Breast Cancer

• Status: Unknown
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 256 (estimated)
• Sponsor: Centre Henri Becquerel · Academic / Other
• Sex: Female
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Adjuvant chemotherapy is frequently proposed to patients presenting early breast cancer, in case of high risk of recurrence (large tumors, node involvement, high grade…). Due to its toxicity toward veins, chemotherapy must be administered through a central venous device. Today, one can use either an implanted port or a PICC line (Peripherally Inserted Central Catheter). A PICC line is easier to implant and to explant, but has to be flushed every week and may impact daily life (no swimming, some clothes may not fit). On the other hand, a port is subcutaneous and lets patients lead a normal life, but its implant and explant require a cutaneous incision with possible complications (bleeding, pain, infection). For both venous devices, complications such as thrombosis or infection may happen. Published data comparing the two devices are heterogeneous and do not often distinguish patients treated for different diseases at various stages. Empirically in daily practice, for long term use (\>6 months) a port is usually preferred, whereas for short-term treatments (\<6 weeks) a PICC line is used. In the case of Her2 negative early breast cancer, adjuvant chemotherapy usually lasts 4 to 5 months. There is no scientific evidence for preferring one device to the other for these patients. The aim of this study is to prospectively compare the patients' satisfaction and tolerance of each of the two devices.

Detailed description

The intravenous device will be randomly attributed. The adjuvant chemotherapy regimen will be selected according the standards of the center ( 6 cycles of FEC100 or 3 cycles of FEC100 then 3 cycles of Taxotere (docetaxel). The patient will be followed as per center's standards and visits (prior, during and after every drug administration, then monthly for six months). All Adverse Events will be reported.

Conditions

• Early Stage Breast Carcinoma

Interventions

Type	Name	Description
DEVICE	implanted port for chemo administration (X-port isp)
DEVICE	Use of a PICC line for chemo administration (PowerPICC SOLO²)	The description of the device could found on the published marketing authorisation

Timeline

• Start date: 2014-04-01
• Primary completion: 2018-12-01
• Completion: 2019-03-01
• First posted: 2014-03-26
• Last updated: 2018-07-24

Locations

1 site across 1 country: France