Trial Summary
What is the purpose of this trial?This trial is testing whether breast cancer patients can safely skip a medication during part of their chemotherapy. This medication helps with white blood cell recovery but can cause painful side effects. The study aims to see if omitting this medication can improve patients' quality of life without increasing infection risks.
Is skipping the drug G-CSF a promising treatment for breast cancer?Skipping G-CSF might be promising because it can reduce costs and avoid side effects like bone pain, while still effectively treating early breast cancer with paclitaxel.23589
What safety data exists for G-CSF omission in breast cancer treatment?The safety data for G-CSF omission in breast cancer treatment includes studies that suggest routine prophylactic G-CSF may not be necessary with accelerated paclitaxel for early breast cancer, as it is expensive and causes bone pain. Other studies have evaluated the safety and efficacy of recombinant G-CSF in preventing neutropenic complications in breast cancer patients, showing that it can reduce the incidence of severe neutropenia and neutropenic fever. Flexible G-CSF dosing has been suggested to maintain taxol dose intensity while managing febrile neutropenia. Overall, G-CSF is effective in reducing myelosuppression and allowing higher chemotherapy doses, but its omission may be considered in certain contexts to avoid side effects.13457
What data supports the idea that G-CSF Omission for Breast Cancer is an effective treatment?The available research shows that routine use of G-CSF may not be necessary for early breast cancer patients receiving accelerated paclitaxel, as it is expensive and can cause bone pain. However, G-CSF is effective in managing side effects like neutropenia, a condition where white blood cell levels drop, which can happen with chemotherapy. In other cancers, like ovarian cancer, flexible G-CSF dosing has allowed patients to maintain higher doses of chemotherapy, which could suggest potential benefits in breast cancer treatment as well. Overall, while G-CSF helps manage side effects, its omission in certain breast cancer treatments might be possible without compromising effectiveness.12356
Do I have to stop taking my current medications for this trial?The trial protocol does not specify if you need to stop taking your current medications. However, it focuses on whether to use G-CSF during a specific chemotherapy treatment, so it's best to discuss your current medications with the trial team.
Eligibility Criteria
This trial is for early-stage or locally-advanced breast cancer patients who are about to receive DD-AC/T chemotherapy and need drugs to prevent infection due to low white blood cell counts. Participants must be able to consent and complete questionnaires in English or French, but can't join if they have metastatic cancer, past severe reactions to G-CSF, recent chemo within 5 years, or other serious health issues.Inclusion Criteria
I am getting specific chemotherapy for breast cancer and need medicine to prevent infection.
Exclusion Criteria
I have had chemotherapy in the past 5 years.
I have not used pegfilgrastim or filgrastim before joining this study.
My cancer has spread to other parts of my body.
Treatment Details
The study is testing whether it's safe for breast cancer patients on the paclitaxel part of their DD-AC/T chemotherapy regimen to skip taking G-CSF—a drug usually given to boost white blood cells and prevent infections. Patients will either continue with G-CSF as usual or go without it during this phase of treatment.
2Treatment groups
Experimental Treatment
Active Control
Group I: Omission of G-CSFExperimental Treatment1 Intervention
Omission of G-CSF injections after each cycle of paclitaxel chemotherapy.
Group II: Receive G-CSFActive Control1 Intervention
Receive G-CSF injections (either filgrastim or pegfilgrastim) after each cycle of paclitaxel chemotherapy.
Omission of Granulocyte Colony-Stimulating Factor (G-CSF) is already approved in United States, European Union for the following indications:
🇺🇸 Approved in United States as Paclitaxel for:
- Advanced ovarian cancer
- Metastatic breast cancer
- Non-small cell lung cancer
- Kaposi sarcoma
🇪🇺 Approved in European Union as Paclitaxel for:
- Ovarian cancer
- Breast cancer
- Non-small cell lung cancer
- Kaposi sarcoma
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Who is running the clinical trial?
Ottawa Hospital Research InstituteLead Sponsor
References
Flexible granulocyte colony-stimulating factor dosing in ovarian cancer patients who receive dose-intense taxol therapy. [2021]As has been reported with other chemotherapeutic agents, evidence is emerging to suggest that increased taxol dose intensity is associated with improved therapeutic efficacy. Granulocyte colony-stimulating factor (G-CSF) effectively protects the bone marrow from taxol-induced neutropenia and allows for higher taxol dose administration. This report addresses the optimal use of G-CSF as a supportive agent for dose-intense taxol therapy. Forty-seven patients were evaluated. Each ovarian cancer patient received taxol with G-CSF support, with starting doses of 250 mg/m2 per 21 days and 10 micrograms/kg/d, respectively. Five patients were treated with the same dose of G-CSF for multiple cycles. Forty-two patients were given "flexible" G-CSF dosing. Instead of reducing taxol dose after a cycle of therapy complicated by febrile neutropenia (F+N+), the G-CSF dose was increased. Only after a second episode of F+N+ was the taxol dose reduced. The initial 5 patients who developed F+N+ after taxol (250 mg/m2) and G-CSF (10 micrograms/kg/d) were retreated at the same doses of both drugs; subsequently, 4 of 5 patients had another episode of F+N+. With flexible G-CSF dosing, taxol dose intensity could be maintained at the target level in 34 of 42 patients (81% of the cohort). Sixteen of these patients (38% of the cohort) would have required taxol dose reductions for F+N+ if flexible G-CSF dosing had not been used. By increasing the G-CSF dose when indicated, patients at high risk for recurrence of F+N+, because they had already experienced one episode, appeared to have a lower risk of developing a recurrent episode. These data suggest that flexible G-CSF dosing may have merit and may allow the administration of more dose-intense taxol. A prospective, randomized, controlled clinical trial of flexible G-CSF dosing versus fixed-dose G-CSF appears warranted.
Recombinant human granulocyte colony-stimulating factor in the management of cancer patients: five years on. [2018]Recombinant human granulocyte colony-stimulating factor (G-CSF) has been used worldwide in cancer patients for over 1 year, and (only 5 years from the first publication on the clinical use of this growth factor) experience is rapidly accumulating in many oncological situations. Several randomized studies have confirmed its value in allowing the optimal delivery of chemotherapy without undue dose reductions or dose delays, while at the same time reducing the overall risks of febrile neutropenia associated with the use of cytotoxic chemotherapy. Its virtual lack of significant side effects, its selectivity of action, its rapid effect on neutrophil kinetics (reducing both the maturation and release times of bone marrow neutrophils to 1-2 days rather than the normal 4-5 days), and the reproducible augmentation of neutrophil production in several neoplastic and nonneoplastic situations, as well as the activation of myeloid cell functions, have made G-CSF the growth factor of choice in most cancer units. Some of the published information regarding its current and potential use in the management of oncological patients is summarized here.
Paclitaxel and recombinant human granulocyte colony-stimulating factor as initial chemotherapy for metastatic breast cancer. [2017]A phase II study of Taxol (paclitaxel; Bristol-Myers Squibb Co, Princeton, NJ) as initial chemotherapy for metastatic breast cancer was conducted. Recombinant human granulocyte colony-stimulating factor (rhG-CSF) was used to ameliorate myelosuppression, the anticipated dose-limiting toxicity.
Toxicity and activity of docetaxel in anthracycline-pretreated breast cancer patients: a phase II study. [2019]Docetaxel has proven effective in advanced breast cancer. Myelosuppression and cumulative fluid retention syndrome are troublesome, potentially avoidable toxicities. In this consecutive cohort study, docetaxel (100 mg/m2 by 1 hour i.v. infusion, q3 weeks) activity and toxicity was explored in 56 anthracycline-pretreated patients (eligible: 55: median age: 51 years [range: 28-68 years]; median performance status: 0 [range: 0-3]) with metastatic breast cancer, using two different granulocyte colony-stimulating factor and steroid pre- and postmedication schedules. Twenty-nine patients (group A) received a 5-day oral prednisone premedication, and 26 (group B) received 4-day low-dose i.m. dexamethasone; group B patients also received prophylactic granulocyte colony-stimulating factor. All patients were evaluable for toxicity and 53 for response. Prophylactic granulocyte colony-stimulating factor significantly lowered the incidence of grade III-IV neutropenia and neutropenic fever (p = 0.0001 and 0.01, respectively). The incidence of moderate-severe fluid retention syndrome was lower in patients receiving i.m. dexamethasone (p = 0.08). Overall response rate was 53% (4 complete responses/24 partial responses, 95% confidence interval 39.4-66.2%); 32% have stable disease and 15% progressive disease. In 21 anthracycline-refractory/resistant patients, as well as in 10 paclitaxel-pretreated patients, the overall response rate was 50%. Docetaxel is highly active in anthracycline- and paclitaxel-pretreated metastatic breast cancer, with manageable toxicity. Optimal use of both granulocyte colony-stimulating factor support and steroid premedication deserves further investigation.
Routine prophylactic granulocyte colony stimulating factor (GCSF) is not necessary with accelerated (dose dense) paclitaxel for early breast cancer. [2015]Prophylactic granulocyte colony stimulating factor (GCSF) is recommended with accelerated adjuvant chemotherapy but is expensive and causes bone pain. We have reviewed a series of patients with early breast cancer treated with accelerated 2-weekly paclitaxel without routine GCSF to assess its need.
[Safety and efficacy study of the recombinant granulocyte colony-stimulating factor for prevention of neutropenia and neutropenia-related complications in women with metastatic breast cancer receiving docetaxel/doxorubicin]. [2018]We evaluated efficacy and safety of recombinant granulocyte-colony stimulating factor (rGCSF) used as primary prophylaxis to prevent neutropenia and neutropenia-related complications induced by docetaxel and doxorubicin chemotherapy in patients with metastatic breast cancer.
An open-label multicenter safety, tolerability, and efficacy study of recombinant granulocyte colony-stimulating factor in the prevention of neutropenic complications in breast cancer patients. [2018]The primary objective of this open-label, two chemotherapy arm, phase 4 study was to evaluate the safety and efficacy of newly developed recombinant granulocyte colony-stimulating factor (rG-CSF) used to prevent neutropenia-related complications in patients with metastatic breast cancer treated with docetaxel (75 mg/m(2)) and doxorubicin (50 mg/m(2)) or docetaxel (100 mg/m(2)) alone.
The impact of the granulocyte colony-stimulating factor on chemotherapy dose intensity and cancer survival: a systematic review and meta-analysis of randomized controlled trials. [2022]The granulocyte colony-stimulating factor (G-CSF) is utilized to reduce neutropenic complications in patients receiving cancer chemotherapy. This study represents a systematic review and evidence summary of the impact of G-CSF support on chemotherapy dose intensity and overall mortality.
Outcomes of chemotherapy-induced (febrile) neutropenia prophylaxis with biosimilar filgrastim (Zarzio®) initiated "same-day" ( 72 h): findings from the MONITOR-GCSF study. [2020]Granulocyte colony-stimulating factors (G-CSFs) are indicated for prophylaxis or management of chemotherapy-induced neutropenia (CIN) and febrile neutropenia (FN). Guidelines recommend G-CSF 24-72 h following chemotherapy; however, some evidence suggests that G-CSF initiated