Early-stage Breast CancerPhase 4REaCT-OGFNCT05753618
Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy
A Phase 4 study testing Granulocyte Colony-Stimulating Factor (G-CSF) and Omission of Granulocyte Colony-Stimulating Factor (G-CSF) in people with Early-stage Breast Cancer, run by Ottawa Hospital Research Institute at 3 sites in Canada.
Trial summary
The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Early-stage Breast Cancer
- What is being tested?
- Granulocyte Colony-Stimulating Factor (G-CSF) and Omission of Granulocyte Colony-Stimulating Factor (G-CSF)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 242 participants
- Where
- 3 sitesCanada
- Study dates
- 17 Apr 2023to Oct 2026
- Phase
- Phase 4
- Are there results?
- Not yet: the study is under way
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
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC/T chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
- Able to provide verbal consent
- Able to complete questionnaires in English or French
Who cannot join
- No access to pegfilgrastim or filgrastim prior to randomization
- Metastatic cancer
- Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
- Patients received prior cytotoxic chemotherapy within the last 5 years
- Patients with uncontrolled inter-current illness that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study
Trial locations and contacts
3 sites in 1 country. Contact the study team or a site near you to ask about taking part.
Canada3 sites, 3 recruiting
- Recruiting
Kingston Health Sciences Centre
Kingston, Ontario, K7L 2V7
- Recruiting
Lakeridge Health
Oshawa, Ontario, L1G 2B9
- Recruiting
The Ottawa Hospital Cancer Centre
Ottawa, Ontario, K1H 8L6
Lisa Vandermeer, MSc, 613-737-7700, lvandermeer@ohri.ca
About this study
Official title: A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)
The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy.
Read the detailed description
Optimal curative chemotherapy treatment in the early-stage setting for breast cancer patients can reduce the risk of recurrence and result in improvement in breast cancer survival. The pivotal Cancer and Leukemia Group B (CALGB) 9741 clinical trial demonstrated improved efficacy from administering 4 cycles of adriamycin and cyclophosphamide (AC) followed by 4 cycles of paclitaxel using a dose-dense schedule every 2-weeks instead of every 3 weeks in patients with high-risk early-stage breast cancer. It has since become a widely accepted standard care treatment option. Granulocyte colony-stimulating factor (G-CSF) such as filgrastim (FIL) and pegfilgrastim (PEG) are key supportive medications used with the dose-dense regimen to facilitate timely recovery of neutrophil count before the next cycle of treatment. However, G-CSF is associated with increased bone pain after chemotherapy (up to 40%) and drug-induced fever, which can result in additional clinical or emergency room visits. Clinicians have questioned if primary prophylactic G-CSF use is necessary with paclitaxel in the dose-dense regimen and the risk of hematological toxicity, such as the risk of low neutrophils and the risk of infection is lower with paclitaxel. Results from two retrospective studies suggest that it is safe and feasible to omit G-CSF during the paclitaxel portion of the DD-AC/T regimen. Based on the current trial data, there is a stong suggestion that it is safe, feasible and likely preferable to omit G-CSF during the paclitaxel portion of DD-AC/T chemotherapy. Given the majority of chemotherapy dose delays are related to issues such as bone pain (from G-CSF and paclitaxel) and peripheral neuropathy (from paclitaxel), and this may even be exacerbated by the use of G-CSF, it is anticipated that omitting G-CSF during paclitaxel chemotherapy may improve completion rates while improving health related quality of life (HR-QoL). Therefore, the researchers propose a randomized study to further evaluate patient-reported bone pain and HR-QoL from the omission of primary prophylactic G-CSF use during the paclitaxel portion of DD-AC/T chemotherapy while demonstrating supportive evidence that omitting G-CSF is safe and feasible.
- Conditions
- Early-stage Breast Cancer
- Being tested
- Granulocyte Colony-Stimulating Factor (G-CSF), Omission of Granulocyte Colony-Stimulating Factor (G-CSF)
- Keywords
- Filgrastim, Pegfilgrastim, Bone pain, Paclitaxel
- Medical subject headings
- Breast Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Granulocyte Colony-Stimulating Factor (G-CSF)Drug
Also called Filgrastim, Pegfilgrastim
Participants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy.
Omission of Granulocyte Colony-Stimulating Factor (G-CSF)Drug
Participants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy
| Study group | Role | What they receive |
|---|---|---|
| Receive G-CSF | Active comparator | Receive G-CSF injections (either filgrastim or pegfilgrastim) after each cycle of paclitaxel chemotherapy. Receives: Drug: Granulocyte Colony-Stimulating Factor (G-CSF) |
| Omission of G-CSF | Experimental | Omission of G-CSF injections after each cycle of paclitaxel chemotherapy. Receives: Drug: Omission of Granulocyte Colony-Stimulating Factor (G-CSF) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Patient-reported bone pain during cycle 1 of paclitaxel
The primary outcome is patient-reported bone pain from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) using the trapezoidal quadrature method for patients reported daily pain score from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. Day 1 being the morning after first dose of G-CSF injection, or 48 hours after chemotherapy injection in the No G-CSF arm. The daily pain score ranges from 0-40. Peak pain is defined as the maximum pain rating over day 1 to day 5. To reiterate the scoring system, every morning, patients are asked to rate the most severe pain they experienced in the last 24 hours on a visual analogue scale (VAS) from 0 (no pain) to 10 (pain as bad as you can imagine). The X axis of the AUC represents time (i.e., days) and the Y axis represents pain severity (0-10).
Measured: At the end of cycle 1 of paclitaxel chemotherapy (each cycle is 14 days)
Secondary outcomes (13)
Patient-reported bone pain across all paclitaxel cycles
Bone pain mean AUC across all cycles of paclitaxel chemotherapy. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) using the trapezoidal quadrature method for patients reported daily pain score from day 1 to 5 during all cycles of paclitaxel chemotherapy. Day 1 being the morning after first dose of G-CSF injection, or 48 hours after chemotherapy injection in the No G-CSF arm. The daily pain score ranges from 0-40. Peak pain is defined as the maximum pain rating over day 1 to day 5. To reiterate the scoring system, every morning, patients are asked to rate the most severe pain they experienced in the last 24 hours on a visual analogue scale (VAS) from 0 (no pain) to 10 (pain as bad as you can imagine). The X axis of the AUC represents time (i.e., days) and the Y axis represents pain severity (0-10).
Measured: After each of the paclitaxel chemotherapy cycles (each cycle is 14 days)
Peak bone pain experienced
Peak bone pain experienced across all cycles of paclitaxel. Measured by the patient reported daily pain score from days 1 to 5 during all 4 cycles of paclitaxel chemotherapy. Bone pain is measured on a scale ranging from 0-10, 0 being no pain and 10 being the worst possible pain.
Measured: Days 1 to 5 of the each of the paclitaxel chemotherapy cycles (each cycle is 14 days)
Patient health-related quality of life
Patient Health-Related Quality of Life (HR-QoL) based on the EuroQol 5 Dimension 5 Level (EQ-5D-5L) questionnaire.
Measured: Through study completion, average of 12 weeks
Rates of completion of 4 cycles of paclitaxel
Rates of completion of 4 cycles of paclitaxel chemotherapy within 7 weeks (days 1 cycle 5 to day 1 cycle 8 of chemotherapy)
Measured: Through study completion, average of 12 weeks
Dose-intensity of paclitaxel chemotherapy
Dose intensity of paclitaxel (mg/m2/wk) chemotherapy. Dose intensity is a measure of a dose delay/dose reduction and premature chemotherapy discontinuation.
Measured: Through study completion, average of 12 weeks
Incidence of febrile neutropenia/neutropenia
Incidences of febrile neutropenia/neutropenia will be collected using pretreatment bloodwork that is routinely performed before each chemotherapy cycle. For this study, febrile neutropenia (FN) is defined as a one-time oral temperature greater or equal to 38.3 degrees Celsius (approximately 100.9 Fahrenheit) or a sustained temperature equal or greater than 38 degrees Celsius for 1 or more hours in a patient who has an absolute neutrophil count of less than 500 cells/microliter or an absolute neutrophil count expected to decrease to less than 500 cells/microliter within a 48-hour period.
Measured: Through study completion, average of 12 weeks
Incidence of treatment-related hospitalizations/ER visits
The number of treatment-related hospitalizations and emergency room visits that occur from the start of paclitaxel chemotherapy to 1 month after the last paclitaxel chemotherapy cycle
Measured: Through study completion, average of 12 weeks
Healthcare resource utilization: Emergency Room Visits
The number of emergency room visits that occur will be collected.
Measured: Through study completion, average of 12 weeks
Healthcare resource utilization: Planned and Unplanned Provider Visits
The number of planned and unplanned provider clinic visits, including visits to stretcher bay will be collected.
Measured: Through study completion, average of 12 weeks
Healthcare resource utilization: Phone Calls and Emails
The number of phone calls and emails to patient support line provider (reported by the patient) will be collected.
Measured: Through study completion, average of 12 weeks
Cost-effectiveness ratios
There will be a cost-utility analysis comparing the differences in cost and quality-adjusted life years (QALY) between omitting G-CSF and standard G-CSF use. The statistical analysis will be conducted in accordance with current guidelines for clinical and cost-effectiveness analysis alongside randomized clinical trials (RCTs). Health utility values will be derived from EQ-5D-5L scores using the published mapping algorithm.
Measured: Through study completion, average of 12 weeks
Incidence of chemotherapy-related mortality
Deaths from start of chemotherapy to one month after completion of last chemotherapy cycle
Measured: Through study completion, average of 12 weeks
Rate of secondary G-CSF or antibiotic use
Rates of added G-CSF use for both randomization arms will be collected. As well as the addition of antibiotic use.
Measured: Through study completion, average of 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Mar 2023
- Study start17 Apr 2023
- Primary completionOct 2026 (estimated)
- Study completionOct 2026 (estimated)
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
- 242 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Ottawa Hospital Research Institute
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Xinni Song, MD, Principal investigator, Ottawa Hospital Research Institute
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05753618
- Sponsor's protocol ID
- REaCT-OGF
- Acronym
- REaCT-OGF
- Status last verified
- Jul 2026
- First submitted
- 24 Jan 2023
- Last updated
- 8 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized Pragmatic Trial Evaluating Omission of Granulocyte Colony-stimulating Factors in Breast Cancer Patients Receiving Paclitaxel Portion of Dose-dense Adriamycin-cyclophosphamide and Paclitaxel Chemotherapy (REaCT-OGF)
- ClinicalTrials.gov ID
- NCT05753618
- Acronym / sponsor ID
- REaCT-OGF / REaCT-OGF
- Conditions
- Early-stage Breast Cancer
- Keywords
- Filgrastim, Pegfilgrastim, Bone pain, Paclitaxel
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 242 participants (estimated)
- Lead sponsor
- Ottawa Hospital Research InstituteUniversity, hospital or other
- Study start
- 17 Apr 2023 (actual)
- Primary completion
- Oct 2026 (estimated)
- Study completion
- Oct 2026 (estimated)
- First posted
- 3 Mar 2023 (actual)
- 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.
The goal of this randomized, pragmatic clinical trial is to evaluate the omission of granulocyte colony-stimulating factors (G-CSF) in breast cancer patients receiving paclitaxel portion of dose-dense adriamycin-cyclophosphamide and paclitaxel (DD-AC/T) chemotherapy. Participants will be randomized to either take G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy or to omit G-CSF while on the paclitaxel portion of DD-AC/T chemotherapy.
Detailed description
Optimal curative chemotherapy treatment in the early-stage setting for breast cancer patients can reduce the risk of recurrence and result in improvement in breast cancer survival. The pivotal Cancer and Leukemia Group B (CALGB) 9741 clinical trial demonstrated improved efficacy from administering 4 cycles of adriamycin and cyclophosphamide (AC) followed by 4 cycles of paclitaxel using a dose-dense schedule every 2-weeks instead of every 3 weeks in patients with high-risk early-stage breast cancer. It has since become a widely accepted standard care treatment option. Granulocyte colony-stimulating factor (G-CSF) such as filgrastim (FIL) and pegfilgrastim (PEG) are key supportive medications used with the dose-dense regimen to facilitate timely recovery of neutrophil count before the next cycle of treatment. However, G-CSF is associated with increased bone pain after chemotherapy (up to 40%) and drug-induced fever, which can result in additional clinical or emergency room visits. Clinicians have questioned if primary prophylactic G-CSF use is necessary with paclitaxel in the dose-dense regimen and the risk of hematological toxicity, such as the risk of low neutrophils and the risk of infection is lower with paclitaxel. Results from two retrospective studies suggest that it is safe and feasible to omit G-CSF during the paclitaxel portion of the DD-AC/T regimen. Based on the current trial data, there is a stong suggestion that it is safe, feasible and likely preferable to omit G-CSF during the paclitaxel portion of DD-AC/T chemotherapy. Given the majority of chemotherapy dose delays are related to issues such as bone pain (from G-CSF and paclitaxel) and peripheral neuropathy (from paclitaxel), and this may even be exacerbated by the use of G-CSF, it is anticipated that omitting G-CSF during paclitaxel chemotherapy may improve completion rates while improving health related quality of life (HR-QoL). Therefore, the researchers propose a randomized study to further evaluate patient-reported bone pain and HR-QoL from the omission of primary prophylactic G-CSF use during the paclitaxel portion of DD-AC/T chemotherapy while demonstrating supportive evidence that omitting G-CSF is safe and feasible.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Receive G-CSF | Active comparator | Drug: Granulocyte Colony-Stimulating Factor (G-CSF)Receive G-CSF injections (either filgrastim or pegfilgrastim) after each cycle of paclitaxel chemotherapy. |
| Omission of G-CSF | Experimental | Drug: Omission of Granulocyte Colony-Stimulating Factor (G-CSF)Omission of G-CSF injections after each cycle of paclitaxel chemotherapy. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Patients with early-stage or locally-advanced breast cancer receiving neoadjuvant or adjuvant DD-AC/T chemotherapy requiring primary febrile neutropenia prophylaxis with G-CSF
- Able to provide verbal consent
- Able to complete questionnaires in English or French
Key exclusion criteria (5 listed)
- No access to pegfilgrastim or filgrastim prior to randomization
- Metastatic cancer
- Known hypersensitivity to filgrastim or pegfilgrastim or one of its components
- Patients received prior cytotoxic chemotherapy within the last 5 years
- Patients with uncontrolled inter-current illness that would limit compliance with study requirements or other significant diseases or disorders that, in the investigator's opinion, would exclude the subject from participating in the study
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 |
|---|---|---|
| Granulocyte Colony-Stimulating Factor (G-CSF)Also: Filgrastim, PegfilgrastimParticipants will receive G-CSF injection (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy. | Drug | Receive G-CSF |
| Omission of Granulocyte Colony-Stimulating Factor (G-CSF)Participants will omit the use of G-CSF (either filgrastim or pegfilgrastim) after each paclitaxel cycle of DD-AC/T chemotherapy | Drug | Omission of G-CSF |
Primary outcome
Patient-reported bone pain during cycle 1 of paclitaxel
Time frame: At the end of cycle 1 of paclitaxel chemotherapy (each cycle is 14 days)
The primary outcome is patient-reported bone pain from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. The total measure of bone pain over the five days will be summarized by the area under the curve (AUC) using the trapezoidal quadrature method for patients reported daily pain score from day 1 to 5 during cycle 1 of paclitaxel chemotherapy. Day 1 being the morning after first dose of G-CSF injection, or 48 hours after chemotherapy injection in the No G-CSF arm. The daily pain score ranges from 0-40. Peak pain is defined as the maximum pain rating over day 1 to day 5. To reiterate the scoring system, every morning, patients are asked to rate the most severe pain they experienced in the last 24 hours on a visual analogue scale (VAS) from 0 (no pain) to 10 (pain as bad as you can imagine). The X axis of the AUC represents time (i.e., days) and the Y axis represents pain severity (0-10).
13 secondary outcomes
Patient-reported bone pain across all paclitaxel cycles
Time frame: After each of the paclitaxel chemotherapy cycles (each cycle is 14 days)
Peak bone pain experienced
Time frame: Days 1 to 5 of the each of the paclitaxel chemotherapy cycles (each cycle is 14 days)
Patient health-related quality of life
Time frame: Through study completion, average of 12 weeks
Rates of completion of 4 cycles of paclitaxel
Time frame: Through study completion, average of 12 weeks
Dose-intensity of paclitaxel chemotherapy
Time frame: Through study completion, average of 12 weeks
Incidence of febrile neutropenia/neutropenia
Time frame: Through study completion, average of 12 weeks
Incidence of treatment-related hospitalizations/ER visits
Time frame: Through study completion, average of 12 weeks
Healthcare resource utilization: Emergency Room Visits
Time frame: Through study completion, average of 12 weeks
Healthcare resource utilization: Planned and Unplanned Provider Visits
Time frame: Through study completion, average of 12 weeks
Healthcare resource utilization: Phone Calls and Emails
Time frame: Through study completion, average of 12 weeks
Cost-effectiveness ratios
Time frame: Through study completion, average of 12 weeks
Incidence of chemotherapy-related mortality
Time frame: Through study completion, average of 12 weeks
Rate of secondary G-CSF or antibiotic use
Time frame: Through study completion, average of 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Jul 2026.
- The Rethinking Clinical Trials (REaCT) websiteLink provided by the sponsor.
Related trials for Early-stage Breast Cancer
RecruitingObservational study
A Study to Assess Treatment Patterns and Treatment Adherence in Early HER2-positive Breast Cancer Participants After Treatment Decentralization
Early-stage HER2+ Breast Cancer
RecruitingPhase 2
Study of Patritumab Deruxtecan Plus Pembrolizumab With Other Anticancer Agents in Participants With High-Risk Early-Stage Triple-Negative or Hormone Receptor-Low Positive/HER-2 Negative Breast Cancer (MK-1022-010, HERTHENA-Breast-03)
Breast Neoplasms, Breast Cancer
RecruitingPhase 2
BRE-04: Window of Opportunity Trial of Preoperative Low Dose Azacitidine in High-Risk Early Stage Breast Cancer
Breast Cancer Invasive, Early-stage Breast Cancer
Active, not recruitingObservational study
Longitudinal ctDNA Surveillance for Older Women With ER+ Breast Cancer Who Omit Surgery
Breast Cancer
RecruitingObservational study
Collecting Blood Samples From Patients With and Without Cancer to Evaluate Tests for Early Cancer Detection
Acute Lymphoblastic Leukemia, Acute Myeloid Leukemia
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.
Xinni Song, MD principal investigator
Ottawa Hospital Research Institute
3 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Granulocyte Colony-Stimulating Factor (G-CSF) and Omission of Granulocyte Colony-Stimulating Factor (G-CSF) in people with Early-stage Breast Cancer, run by Ottawa Hospital Research Institute at 3 sites 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 3 inclusion and 5 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: looking for participants now, as of the sponsor's last update on 8 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 3 sites 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Lisa Vandermeer, MSc (613-737-7700, lvandermeer@ohri.ca), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Patient-reported bone pain during cycle 1 of paclitaxel (time frame: At the end of cycle 1 of paclitaxel chemotherapy (each cycle is 14 days)). 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 8 Jul 2026.