Clinical trial · Interventional
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
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (1)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Early Stage Breast Carcinoma | Early Stage Breast Carcinoma | ONTOLOGY_EXACT | 0.98 |
Interventions
Interventions (2)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| implanted port for chemo administration (X-port isp) | Device | — | UNRESOLVED |
| Use of a PICC line for chemo administration (PowerPICC SOLO²) | Device | — | UNRESOLVED |
Design
Arms and outcomes
Arms (2)
- type
- EXPERIMENTAL
- label
- PICC line
- description
- Use of a PICC line for chemo administration (PowerPICC SOLO²)
- interventionNames
- Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)
- type
- ACTIVE_COMPARATOR
- label
- Implanted Port
- description
- Use of an implanted port for chemo administration
- interventionNames
- Device: implanted port for chemo administration (X-port isp)
- Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)
Primary outcomes (1)
- measure
- Probability of occurrence of a significant adverse event related to the central venous device
Eligibility
Eligibility (as posted)
- Sex
- Female
- Minimum age
- 18 Years
Show eligibility criteria text
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
References
Publications (1)
- DERIVEDLefebvre 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