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

Phase 2

• Conditions: Early Stage Breast Carcinoma
• Interventions: Device: Use of a PICC line for chemo administration (PowerPICC SOLO²); Device: implanted port for chemo administration (X-port isp)

• Registration Number: NCT02095743
• Lead Sponsor: Centre Henri Becquerel

Brief 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.

Study Timeline

• Study First Submitted: 2013-10-25
• Study First Submitted QC: 2014-03-24
• Study First Posted: 2014-03-26
• Study Start: 2014-04
• Status Verified: 2018-07
• Last Update Submitted: 2018-07-20
• Last Update Posted: 2018-07-24
• Primary Completion: 2018-12
• Study Completion: 2019-03

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 256

Inclusion Criteria

• Women age > 18
• Documented breast cancer
• No Her2 overexpression
• Patients operated with curative intent (no distant metastasis at diagnosis)
• Patients undergoing an adjuvant chemotherapy consisting of 3 courses of FEC 100 (5-fluorouracil, epirubicin 100mg/m² and cyclophosphamide ) followed by 3 courses of Taxotere, or 6FEC100 (according to CHB refencial for localised breast cancer treatment).
• Signed informed consent

Exclusion Criteria

• Bilateral axillary node dissection
• History of bilateral upper thoracic irradiation
• Cutaneous disease (eczema, scleroderma, infection...) at catheter insertion site (arm or upper thorax)
• Recent thrombosis of the upper body
• Therapeutic anticoagulation
• Tracheotomy
• Treatment for bacteriemia in process
• Altered hemostasis: INR > 1.5 ; APTT > 1.5 , platelets < 60 G/l
• Renal failure with creatinine clearance < 60mL/min
• Involvement in another trial
• Contraindication to chemotherapy by FEC 100 or taxotere
• Pregnancy or breast feeding
• Protected major patient (under guardianship).
• Psychosocial disorders : decompensated mental disorders, no social security coverage, patient who does not speak french

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PICC line	Use of a PICC line for chemo administration (PowerPICC SOLO²)	Use of a PICC line for chemo administration (PowerPICC SOLO²)
Implanted Port	implanted port for chemo administration (X-port isp)	Use of an implanted port for chemo administration
Implanted Port	Use of a PICC line for chemo administration (PowerPICC SOLO²)	Use of an implanted port for chemo administration

Primary Outcome Measures

Name	Time	Method
Probability of occurrence of a significant adverse event related to the central venous device	37 weeks	To define between the two device (PICC line and implanted port) which one provides the less probability of occurrence of a significant adverse event related to the device (SAERD), from the insertion to the first consultation of survey (36-38 weeks after implantation of the device which is also 5 months after its ablation).

Secondary Outcome Measures

Name	Time	Method
Patients' satisfaction for the use of their central venous device	1 year	Evaluation of the patients' satisfaction assessed by the QLQ C30, and by a 19 questions home-made questionnaire dedicated to the use of central veinous devices

Trial Locations

Locations (1)

Centre Henri Becquerel; 🇫🇷 Rouen, France