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

NCT02095743 | Unknown Phase 2

• 1 other identifier: CHB 13-01
• Study Type: interventional
• Target: 256
• Locations: 1 country
• Sites: 1

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.

Conditions

Early Stage Breast Carcinoma

Keywords

Early breast cancer; Chemotherapy; PICC line; Implanted port

Outcome Measures

Primary Outcomes (1)

• Probability of occurrence of a significant adverse event related to the central venous device

  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).

  37 weeks

Secondary Outcomes (1)

• Patients' satisfaction for the use of their central venous device

  1 year

Study Arms (2)

PICC line

EXPERIMENTAL

Use of a PICC line for chemo administration (PowerPICC SOLO²)

Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)

Implanted Port

ACTIVE COMPARATOR

Use of an implanted port for chemo administration

Device: implanted port for chemo administration (X-port isp); Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)

Interventions

implanted port for chemo administration (X-port isp) DEVICE

Also known as: X-port isp M.R.I Implantable Port (Bard Access Systems Inc)

Implanted Port

Use of a PICC line for chemo administration (PowerPICC SOLO²) DEVICE

The description of the device could found on the published marketing authorisation

Also known as: kit PowerPICC SOLO² (Bard Access Systems Inc)

Implanted Port; PICC line

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Centre Henri Becquerel: lead

Study Sites (1)

Centre Henri Becquerel

Rouen, 76038, France

Location

Related Publications (1)

• Lefebvre L, Noyon E, Georgescu D, Proust V, Alexandru C, Leheurteur M, Thery JC, Savary L, Rigal O, Di Fiore F, Veyret C, Clatot F. Port catheter versus peripherally inserted central catheter for postoperative chemotherapy in early breast cancer: a retrospective analysis of 448 patients. Support Care Cancer. 2016 Mar;24(3):1397-403. doi: 10.1007/s00520-015-2901-8. Epub 2015 Sep 5.

  PMID: 26342484 DERIVED

MeSH Terms

Conditions

Breast Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Study Officials

• Florian Clatot, MD

  Centre Henri Becquerel

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 25, 2013
• First Posted: March 26, 2014
• Study Start: April 1, 2014
• Primary Completion: December 1, 2018
• Study Completion: March 1, 2019
• Last Updated: July 24, 2018

Record last verified: 2018-07

Locations

FR (1)