Breast CancerPhase 3NCT02872103
Placebo-controlled Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
A Phase 3 study testing F-627 in people with Breast Cancer and Neutropenia, run by EVIVE Biotechnology at 1 site in United States.
Trial summary
This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment. Read more about this study
- Who is it for?
- Ages 18 to 74 years, women only
- Conditions the study is for
- Breast Cancer, Neutropenia
- What is being tested?
- F-627
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 122 participants
- Where
- 1 siteUnited States
- Study dates
- Aug 2016to 20 Dec 2017
- Phase
- Phase 3
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 to 74 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- Females ≥ 18 years of age and < 75 years of age.
- Diagnosed with Stage II-IV breast cancer.
- Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
- ECOG Performance status of ≤ 2.
- White Blood Cell count (WBC) ≥ 4.0 × 109/L, hemoglobin ≥ 11.5 g/dL and a platelet count ≥ 150 × 109/L.
- Demonstrate adequate renal, hepatic function (Liver function tests (ALT, AST, alkaline phosphatase and total bilirubin)) should be less than 2.5x upper limits of normal (ULN). Serum creatinine should be less than 1.7x ULN.
- All subjects must agree to use at least one of the following types of contraception: intrauterine device, implantable progesterone device, progesterone intramuscular injection, or oral contraceptive, which has been started at least one month prior to visit one and will continue for the duration of the trial. The contraceptive patch or condom use with spermicide is also acceptable forms of contraception as long as they will be used continually throughout the duration of the trial.
Who cannot join
- Subject is <18 or ≥ 75 years of age.
- Disease progression has occurred while receiving a taxane regimen.
- Subject has undergone radiation therapy within 4 weeks of enrollment.
- Subject has undergone bone marrow or stem-cell transplantation.
- Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
- Subjects that have used G-CSF or any other drug that may potentiate the release of neutrophils (i.e. lithium) within 6 weeks of the screening period are excluded.
Show all 21Show fewer
- Subject has had chemotherapy within 365 days of screening.
- Subject has documented congestive heart failure, cardiomyopathy or myocardial infarction by clinical diagnosis, ECG test, or any other relevant test.
- History of alcohol or drug abuse that would interfere with the ability to be compliant with the study procedure.
- Unwillingness to participate in the study.
- Any underlying medical condition that, in the Investigator's opinion, would make the administration of study drug hazardous to the patient or that would obscure the interpretation of adverse events.
- Receiving other investigational drugs or biologics within 1 month or five half lives of enrollment.
- Any condition, which can cause splenomegaly.
- Chronic constipation or diarrhea, irritable bowel syndrome, inflammatory bowel disease.
- ALT, AST, alkaline phosphatase, total bilirubin ≥ 2.5 upper limit of normal.
- Subject with active infection, or known to be infected with chronic active Hepatitis B within the last 1 year (unless shown at the time of study entry to be Hepatitis B antigen negative), or having any history of Hepatitis C.
- Women who are pregnant or breast-feeding.
- Subject known to be seropositive for HIV, or who have had an AIDS defining illness or a known immunodeficiency disorder.
- Subject with a history of tuberculosis or exposure to tuberculosis. Patients that have received a prior chest X-ray for suspicion of tuberculosis are also excluded unless they have been confirmed to be PPD negative or they had latent tuberculosis that has been previously treated.
- Subjects with Sickle Cell disease
- Subjects with known hypersensitivity to E.coli derived proteins' pegfilgrastim' filgrastim, or any other component of the study drug.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.
Read the detailed description
This is a randomized, multi-center, single dose, double-blind, placebo controlled phase III study of the efficacy and safety of once-per-cycle of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin(doxorubicin)). F-627 is designed to treat neutropenia, an abnormally low number of neutrophils (a type of white blood cell) in the blood. Neutropenia is often seen in cancer patients receiving myelotoxic chemotherapy.
The primary objective of this study is to evaluate the efficacy and safety of single fixed dose of F-627 in breast cancer patients experiencing myelotoxic chemotherapy in comparison to placebo. F-627 or placebo is to be administered subcutaneously 24 hours after chemotherapy in each 21-day cycle of chemotherapy treatment (up to 4 cycles). Patients randomized to placebo arm will receive F-627 except in cycle 1. The primary endpoint will be the duration of grade 4 (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil count (ANC < 0.5 x 10^9/L) observed in chemotherapy cycle 1.
- Conditions
- Breast Cancer, Neutropenia
- Being tested
- F-627, Placebo
- Medical subject headings
- Breast Neoplasms, Neutropenia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
F-627Drug
F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study
PlaceboDrug
Placebo subcutaneous injection on Day 2 of the first TA chemotherapy cycle. TA chemotherapy treatments are part of standard-of-care and not the study.
| Study group | Role | What they receive |
|---|---|---|
| F-627 | Experimental | F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles. Receives: Drug: F-627 |
| Placebo | Placebo comparator | Placebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles. Receives: Drug: F-627; Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo
Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC <0.5x10^9/L) in this cycle is the primary efficacy endpoint.
Measured: The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks
Secondary outcomes (8)
The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles.
The duration of severe neutropenia will be measured for each patient during chemotherapy cycle 2-4 and over all cycles. Each chemotherapy is expected to last 21 days.
Measured: Over all 4 cycles, about 12 weeks
The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.
The duration in days of mild, moderate and severe neutropenia will be recorded for 4 chemotherapy cycles. Grade 2 neutropenia is when a patient's ANC<1.5x10^9/L, Grade 3 neutropenia is when a patient's ANC<1.0x10^9/L, and Grade 4 neutropenia is when a patient's ANC <0.5x10^9/L.
Measured: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles
Febrile neutropenia is defined as a single oral temperature of ≥38.3°C (101°F) or a temperature of >38.0°C (100.4°F) sustained for >1 hour and ANC < 0.5 x 10^9/L
Measured: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles.
The number of subjects with grade 2, 3 and 4 neutropenia will be recorded for all 4 chemotherapy cycles.
Measured: 4 chemotherapy cycles, about 12 weeks
The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.
The time to ANC recovery post nadir for each patient, for each of their chemotherapy cycles will be recorded. Recovery for this protocol is defined as achieving an ANC ≥ 2.0 × 10^9/L after the expected ANC nadir (expected nadir is typically 4-6 days post chemotherapy administration).
Measured: 4 chemotherapy cycles, about 12 weeks
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles.
The depth of ANC nadir for each cycle is the minimal ANC value (× 10^9/L ) for a patient in each chemotherapy cycle
Measured: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles.
The number of subjects with infections for each arm of the study will be recorded for each and all 4 chemotherapy cycles.
Measured: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Use of Antibiotics and Pain Medications
Antibiotics and pain medications use will be recorded for each chemotherapy cycle and overall cycles
Measured: 4 chemotherapy cycles, about 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Aug 2016 (estimated)
- Study startAug 2016
- Primary completion20 Dec 2017
- Study completion20 Dec 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Breast CancerStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 122 participants (actual)
Sponsor and investigators
- Lead sponsor
- EVIVE Biotechnology
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Kevin F Dreyer, Study director, EVIVE Biotechnology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02872103
- Sponsor's protocol ID
- GC-627-04
- Status last verified
- Apr 2021
- First submitted
- 8 Aug 2016
- Last updated
- 5 May 2021
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Glaspy J, Bondarenko I, Burdaeva O, Chen J, Rutty D, Li R, Wang S, Hou Q, Li S. Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial. Support Care Cancer. 2023 Dec 16;32(1):34. doi: 10.1007/s00520-023-08176-6.
PubMed 38103088
Study at a glance
From the registry record, last updated by the sponsor on 5 May 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Multi-Centre, Double-Blind, Placebo Controlled Clinical Trial of F-627 in Women With Breast Cancer Receiving Myelotoxic Chemotherapy
- ClinicalTrials.gov ID
- NCT02872103
- Acronym / sponsor ID
- GC-627-04
- Conditions
- Breast Cancer, Neutropenia
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 122 participants (actual)
- Lead sponsor
- EVIVE BiotechnologyIndustry (pharma, biotech, devices)
- Study start
- Aug 2016
- Primary completion
- 20 Dec 2017 (actual)
- Study completion
- 20 Dec 2017 (actual)
- First posted
- 19 Aug 2016 (estimated)
- Results
- Posted 26 Mar 2019
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This is a randomized, double-blind and placebo controlled phase 3 study to evaluate the efficacy and safety of F-627 in women with stage II-IV breast cancer receiving chemotherapy treatment.
Detailed description
This is a randomized, multi-center, single dose, double-blind, placebo controlled phase III study of the efficacy and safety of once-per-cycle of F-627 in women with stage II-IV breast cancer who are receiving myelotoxic TA chemotherapy treatment (Taxotere (docetaxel) + Adriamycin(doxorubicin)). F-627 is designed to treat neutropenia, an abnormally low number of neutrophils (a type of white blood cell) in the blood. Neutropenia is often seen in cancer patients receiving myelotoxic chemotherapy.
The primary objective of this study is to evaluate the efficacy and safety of single fixed dose of F-627 in breast cancer patients experiencing myelotoxic chemotherapy in comparison to placebo. F-627 or placebo is to be administered subcutaneously 24 hours after chemotherapy in each 21-day cycle of chemotherapy treatment (up to 4 cycles). Patients randomized to placebo arm will receive F-627 except in cycle 1. The primary endpoint will be the duration of grade 4 (severe) neutropenia - the number of days in which the patient has had an absolute neutrophil count (ANC < 0.5 x 10^9/L) observed in chemotherapy cycle 1.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| F-627 | Experimental | Drug: F-627F-627, 20 mg fixed dose pre-filled syringe, dosed Day 2 of each of 4 chemotherapy cycles. |
| Placebo | Placebo comparator | Drug: F-627, Drug: PlaceboPlacebo, pre-filled syringe administered Day 2 of the first chemotherapy cycle; and F-627, 20 mg fixed dose pre-filled syringe administered Day 2 of each of the following 3 chemotherapy cycles. |
Who may qualify
- Ages
- 18 to 74 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- Show evidence of a personally signed and dated informed consent document indicating that the patient has been informed of all pertinent aspects of the trial.
- Females ≥ 18 years of age and < 75 years of age.
- Diagnosed with Stage II-IV breast cancer.
- Subject is scheduled to undergo 4 cycles of TA chemotherapy (docetaxel, doxorubicin, 75, and 60 mg/m2, respectively).
- ECOG Performance status of ≤ 2.
Key exclusion criteria (21 listed)
- Subject is <18 or ≥ 75 years of age.
- Disease progression has occurred while receiving a taxane regimen.
- Subject has undergone radiation therapy within 4 weeks of enrollment.
- Subject has undergone bone marrow or stem-cell transplantation.
- Subject has a history of prior malignancy other than breast cancer that is NOT in remission.
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 |
|---|---|---|
| F-627F-627 subcutaneous injection on Day 2 of TA chemotherapy cycles. TA chemotherapy treatments are part of standard-of-care and not the study | Drug | F-627, Placebo |
| PlaceboPlacebo subcutaneous injection on Day 2 of the first TA chemotherapy cycle. TA chemotherapy treatments are part of standard-of-care and not the study. | Drug | Placebo |
Primary outcome
The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo
Time frame: The first of 4, 21 Day Chemotherapy Cycles, an average of 3 weeks
Subjects will be randomized to F-627 or Placebo at 2:1 ratio. About 24 hours after chemotherapy, subjects will either receive 20mg fixed dose F-627 or Placebo. The subject's absolute neutrophil count (ANC) will be monitored each day post chemotherapy administration until the ANC level exceeds 2.0x10^9/L, then the value will be monitored every three days until the next chemotherapy cycle is entered. The duration of grade 4 neutropenia (ANC <0.5x10^9/L) in this cycle is the primary efficacy endpoint.
8 secondary outcomes
The Duration in Days of Grade 4 (Severe) Neutropenia (ANC < 0.5 × 10^9/L) for Chemotherapy Cycles 2, 3, and 4, and Over All Cycles.
Time frame: Over all 4 cycles, about 12 weeks
The Duration in Days of Grade 2 (Mild), Grade 3 (Moderate) and 4 (Severe) Neutropenia Over All Cycles.
Time frame: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Febrile Neutropenia (FN) for Each Chemotherapy Cycle and Over All Cycles
Time frame: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Grade 2, Grade 3, and Grade 4 Neutropenia for All Chemotherapy Cycles.
Time frame: 4 chemotherapy cycles, about 12 weeks
The Time in Days to ANC Recovery Post Nadir for Each Chemotherapy Cycle and Over All Cycles; Recovery Defined as an ANC ≥ 2.0 × 10^9/L After the Expected ANC Nadir.
Time frame: 4 chemotherapy cycles, about 12 weeks
The Depth of the ANC Nadir for Each Chemotherapy Cycle and Over All Cycles.
Time frame: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Infections for Each Chemotherapy Cycle and Over All Cycles.
Time frame: 4 chemotherapy cycles, about 12 weeks
Number of Participants With Use of Antibiotics and Pain Medications
Time frame: 4 chemotherapy cycles, about 12 weeks
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 May 2021.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 38103088Glaspy J, Bondarenko I, Burdaeva O, Chen J, Rutty D, Li R, Wang S, Hou Q, Li S. Efbemalenograstim alfa, an Fc fusion protein, long-acting granulocyte-colony stimulating factor for reducing the risk of febrile neutropenia following chemotherapy: results of a phase III trial. Support Care Cancer. 2023 Dec 16;32(1):34. doi: 10.1007/s00520-023-08176-6.
- Individual participant dataSharing planned: No
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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.
Kevin F Dreyer study director
EVIVE Biotechnology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing F-627 in people with Breast Cancer and Neutropenia, run by EVIVE Biotechnology at 1 site in United States.
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 8 inclusion and 21 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 5 May 2021. 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 United States. 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. Some participants in this study may receive a placebo. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 26 Mar 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
The Duration in Days of Grade 4 (Severe) Neutropenia Observed in Chemotherapy Cycle 1 in Comparison to Placebo (time frame: The first of 4, 21 Day Chemotherapy Cycles, an average of 3 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 NCT02872103, 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 5 May 2021.