Early Stage Breast Carcinoma | Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer
Early Stage Breast Carcinoma research study
What is the primary objective of this study?
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.
Who is eligible to participate?
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
Which medical condition, disease, disorder, syndrome, illness, or injury is researched?
Early Stage Breast Carcinoma
Interventions can include giving participants drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available or noninvasive approaches such as surveys, education, and interviews.
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
Research studies and clinical trials typically have two or more research arms. An arm is a group of people who receive the same treatment in the study.
PICC lineUse of a PICC line for chemo administration (PowerPICC SOLO²)
Implanted PortUse of an implanted port for chemo administration
Start Date: April 2014
Completed Date: March 2019
Phase: Phase 2
Primary Outcome: Probability of occurrence of a significant adverse event related to the central venous device
Secondary Outcome: Patients' satisfaction for the use of their central venous device
Study sponsors, principal investigator, and references
Principal Investigator: Florian Clatot, MD
Lead Sponsor: Centre Henri Becquerel