Early Stage Breast CancerPhase 4REaCT-TC2NCT02816112
Granulocyte-colony Stimulating Factors or Antibiotics for Primary Prophylaxis for Febrile Neutropenia
A Phase 4 study testing Ciprofloxacin and Neupogen in people with Early Stage Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
Trial summary
Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment… Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Early Stage Breast Cancer
- What is being tested?
- Ciprofloxacin and Neupogen
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 458 participants
- Where
- 1 siteCanada
- Study dates
- Sep 2016to Apr 2020
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Histologically confirmed primary breast cancer
- Planned TC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
Who cannot join
- Contraindication to either Ciprofloxacin or G-CSF
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2
Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100.
The investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.
- Conditions
- Early Stage Breast Cancer
- Being tested
- Ciprofloxacin, Neupogen
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CiprofloxacinDrug
Antibiotic
NeupogenDrug
Also called filgrastim
Granulocyte-colony stimulating factor
| Study group | Role | What they receive |
|---|---|---|
| Ciprofloxacin | Active comparator | Oral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC Receives: Drug: Ciprofloxacin |
| G-CSF | Active comparator | Daily injection at home for the number of days as chosen by the treating physician Receives: Drug: Neupogen |
What is being measured
The primary outcome is the main question the study is designed to answer.
Febrile neutropenia
Number of participants with febrile neutropenia
Measured: 2 years
Treatment-related hospitalization
Number of participants admitted to hospital for treatment-related reasons
Measured: 2 years
Secondary outcomes (4)
Chemotherapy dose reduction
Number of participants who receive a dose reduction of their TC chemotherapy
Measured: 2 years
Chemotherapy dose delay
Number of participants who receive a dose delay in their TC chemotherapy
Measured: 2 years
Chemotherapy discontinuation
Number of participants who stop TC chemotherapy for any reason
Measured: 2 years
Microbiologic infections
Number of participants who have a microbiologic infection (i.e: Clostridium difficile)
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2016 (estimated)
- Study startSep 2016
- Primary completionMar 2020
- Study completionApr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Early Stage Breast CancerStudies of the same condition, open and under way.
- More trials run by Ottawa Hospital Research InstituteThe sponsor's other registered studies.
- 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 458 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Mark Clemons, MD, Principal investigator, The Ottawa Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02816112
- Sponsor's protocol ID
- OTT 16-03
- Acronym
- REaCT-TC2
- Status last verified
- May 2020
- First submitted
- 24 Jun 2016
- Last updated
- 27 May 2020
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No: There is no plan to make IDP available.
Study at a glance
From the registry record, last updated by the sponsor on 27 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multi-Centre Study to Compare Granulocyte-colony Stimulating Factors to Antibiotics for Primary Prophylaxis of Taxotere/Cyclophosphamide-Induced Febrile Neutropenia REaCT-TC2
- ClinicalTrials.gov ID
- NCT02816112
- Acronym / sponsor ID
- REaCT-TC2 / OTT 16-03
- Conditions
- Early Stage Breast Cancer
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 458 participants (actual)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- Sep 2016
- Primary completion
- Mar 2020 (actual)
- Study completion
- Apr 2020 (actual)
- First posted
- 28 Jun 2016 (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.
Taxotere-cyclophosphamide (TC) chemotherapy is commonly used as an adjuvant chemotherapy regimen in patients with resected early stage breast cancer. TC chemotherapy can cause febrile neutropenia (FN) which can be serious and associated with treatment delays and dose reductions, thereby compromising treatment efficacy. To reduce the risk of chemotherapy-induced FN,TC is administered with either one of two highly effective standard treatments; namely primary prophylaxis with either ciprofloxacin or granulocyte colony-stimulating factor (G-CSF). However, there are considerable cost differences between these strategies; subcutaneous daily G-CSF costs at least $12,000 over 4 cycles of treatment while oral ciprofloxacin costs about $100.
The investigators have therefore been performing a feasibility study to explore whether the "integrated consent model" involving oral consent is feasible in practice; and whether it can be used to increase the number of physicians and patients who take part in clinical trials. This feasibility study (REaCT-TC NCT02173262) has been an amazing success and the investigators are therefore now performing a definitive study comparing G-CSF with ciprofloxacin. This study will not be evaluating feasibility endpoints, but rather clinically important endpoints of hospitalizations and febrile neutropenia rates.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Ciprofloxacin | Active comparator | Drug: CiprofloxacinOral tablet taken twice a day at home starting 5 days after chemotherapy for 14 days for every cycle of TC |
| G-CSF | Active comparator | Drug: NeupogenDaily injection at home for the number of days as chosen by the treating physician |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Histologically confirmed primary breast cancer
- Planned TC chemotherapy
- ≥19 years of age
- Able to provide verbal consent
Key exclusion criteria (1 listed)
- Contraindication to either Ciprofloxacin or G-CSF
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 |
|---|---|---|
| CiprofloxacinAntibiotic | Drug | Ciprofloxacin |
| NeupogenAlso: filgrastimGranulocyte-colony stimulating factor | Drug | G-CSF |
Primary outcome
Febrile neutropenia
Time frame: 2 years
Number of participants with febrile neutropenia
Treatment-related hospitalization
Time frame: 2 years
Number of participants admitted to hospital for treatment-related reasons
4 secondary outcomes
Chemotherapy dose reduction
Time frame: 2 years
Chemotherapy dose delay
Time frame: 2 years
Chemotherapy discontinuation
Time frame: 2 years
Microbiologic infections
Time frame: 2 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 May 2020.
- Individual participant dataSharing planned: No. There is no plan to make IDP available.
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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.
Mark Clemons, MD principal investigator
The Ottawa Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Ciprofloxacin and Neupogen in people with Early Stage Breast Cancer, run by Ottawa Hospital Research Institute at 1 site in Canada.
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 4 inclusion and 1 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: finished, as of the sponsor's last update on 27 May 2020. 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 Canada. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Febrile neutropenia (time frame: 2 years). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 27 May 2020.