Early Stage Breast CarcinomaPhase 2EPICNCT02095743
Tolerance of PICC Line Versus Implanted Port for Adjuvant Chemotherapy in Early Breast Cancer
A Phase 2 study testing implanted port for chemo administration (X-port isp) and Use of a PICC line for chemo administration (PowerPICC SOLO²) in people with Early Stage Breast Carcinoma, run by Centre Henri Becquerel at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older, women only
- Conditions the study is for
- Early Stage Breast Carcinoma
- What is being tested?
- implanted port for chemo administration (X-port isp) and Use of a PICC line for chemo administration (PowerPICC SOLO²)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 256 participants
- Where
- 1 siteFrance
- Study dates
- Apr 2014to Mar 2019
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 14Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
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.
Read the 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
- Being tested
- implanted port for chemo administration (X-port isp), Use of a PICC line for chemo administration (PowerPICC SOLO²)
- Keywords
- Early breast cancer, Chemotherapy, PICC line, Implanted port
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
implanted port for chemo administration (X-port isp)Device
Also called X-port isp M.R.I Implantable Port (Bard Access Systems Inc)
Use of a PICC line for chemo administration (PowerPICC SOLO²)Device
Also called kit PowerPICC SOLO² (Bard Access Systems Inc)
The description of the device could found on the published marketing authorisation
| Study group | Role | What they receive |
|---|---|---|
| PICC line | Experimental | Use of a PICC line for chemo administration (PowerPICC SOLO²) Receives: Device: Use of a PICC line for chemo administration (PowerPICC SOLO²) |
| Implanted Port | Active comparator | Use of an implanted port for chemo administration Receives: Device: implanted port for chemo administration (X-port isp); Device: Use of a PICC line for chemo administration (PowerPICC SOLO²) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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).
Measured: 37 weeks
Secondary outcomes (1)
Patients' satisfaction for the use of their central venous device
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
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Mar 2014 (estimated)
- Study startApr 2014
- Primary completionDec 2018 (estimated)
- Study completionMar 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Early Stage Breast CarcinomaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 256 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Henri Becquerel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Florian Clatot, MD, Principal investigator, Centre Henri Becquerel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02095743
- Sponsor's protocol ID
- CHB 13-01
- Acronym
- EPIC
- Status last verified
- Jul 2018
- First submitted
- 25 Oct 2013
- Last updated
- 24 Jul 2018
- Results posted
- No
- Data monitoring committee
- No
Publications
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.
PubMed 26342484
Study at a glance
From the registry record, last updated by the sponsor on 24 Jul 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT02095743
- Acronym / sponsor ID
- EPIC / CHB 13-01
- Conditions
- Early Stage Breast Carcinoma
- Keywords
- Early breast cancer, Chemotherapy, PICC line, Implanted port
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 256 participants (estimated)
- Lead sponsor
- Centre Henri BecquerelUniversity, hospital or other
- Study start
- Apr 2014
- Primary completion
- Dec 2018 (estimated)
- Study completion
- Mar 2019 (estimated)
- First posted
- 26 Mar 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| PICC line | Experimental | Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)Use of a PICC line for chemo administration (PowerPICC SOLO²) |
| Implanted Port | Active comparator | Device: implanted port for chemo administration (X-port isp), Device: Use of a PICC line for chemo administration (PowerPICC SOLO²)Use of an implanted port for chemo administration |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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).
Key exclusion criteria (14 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| implanted port for chemo administration (X-port isp)Also: X-port isp M.R.I Implantable Port (Bard Access Systems Inc) | Device | Implanted Port |
| Use of a PICC line for chemo administration (PowerPICC SOLO²)Also: kit PowerPICC SOLO² (Bard Access Systems Inc)The description of the device could found on the published marketing authorisation | Device | Implanted Port, PICC line |
Primary outcome
Probability of occurrence of a significant adverse event related to the central venous device
Time frame: 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).
1 secondary outcome
Patients' satisfaction for the use of their central venous device
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Jul 2018.
- Derived from this study: PubMed 26342484Lefebvre 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Florian Clatot, MD principal investigator
Centre Henri Becquerel
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing implanted port for chemo administration (X-port isp) and Use of a PICC line for chemo administration (PowerPICC SOLO²) in people with Early Stage Breast Carcinoma, run by Centre Henri Becquerel at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Jul 2018. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Probability of occurrence of a significant adverse event related to the central venous device (time frame: 37 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02095743, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Jul 2018.