Breast Cancer FemalePhase 2/3NCT04554056
Trial to Compare the Efficacy and Safety Of MW05 and PEG-rhG-CSF
A Phase 2/3 study testing MW05 and PEG-rhG-CSF in people with Breast Cancer Female, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
Trial summary
In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1 . Read more about this study
- Who is it for?
- Ages 18 to 70 years, women only
- Conditions the study is for
- Breast Cancer Female
- What is being tested?
- MW05 and PEG-rhG-CSF
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 586 participants
- Where
- 1 siteChina
- Study dates
- 21 Sep 2020to 5 Nov 2022
- Phase
- Phase 2/3
- 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 to 70 years
- Women only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 18～70 years old female(including threshold)
- Diagnosed with breast cancer .
- Weight≥45kg.
- Patients planned to receive TC chemotherapy.
- ECOG ≤ 1
- Estimated survival time ≥ 3 months, and could received at least 4 cycles chemotherapy treatment.
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- Have suitable organs and hematopoietic function
- ECG examination is normal or abnormal has no clinical significance.
- B-ultrasound examination of abdomen showed no obvious abnormality of spleen.
- Willing to sign the informed consent form and able to comply with protocol requirements.
- Non-menopausal or non-surgically sterilized female subjects, the blood pregnancy test results must be negative at the time of screening, and within at least 3 months from the signing of the informed consent form to the end of the last administration, consent to abstinence or the use of effective contraceptive methods.
- -
Who cannot join
- History of other malignant tumors (skin basal cell carcinoma, skin squamous cell carcinoma and / or carcinoma in situ after radical resection can be included in the group after being cured for more than 5 years)
- Primary hematological diseases, including but not limited to myelodysplastic syndrome, aplastic anemia, sickle cell anemia and other hematological diseases that affect bone marrow hematopoiesis.
- With known central nervous system metastasis or suspected central nervous system metastasis based on clinical manifestations.
- With previous history of bone marrow transplantation and / or stem cell transplantation.
- Currently uncontrolled infections or have received systematic anti-infective therapy within 72 hours before randomization.
- Serious chronic diseases of important organs such as kidney and liver.
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- Severe heart disease, including but not limited to:history of congestive heart failure (New York College of Cardiology [NYHA] II or higher heart disease)Angina pectoris that needs to be treated with anti-angina pectoris drugsUncontrollable hypertension (systolic blood pressure ≥ 180 mmHg and / or diastolic blood pressure ≥ 100 mmHg)Arrhythmias requiring drug treatment
- Severe diabetes (such as fundus disease or diabetic foot), or blood sugar is still not well controlled after active treatment.
- Surgery within 2 weeks before chemotherapy or radiotherapy within 4 weeks (except for patients whose physical condition has recovered and can accept the relevant procedures of this study, as determined by the researchers)
- Adverse reactions from previous treatments failed to recover to CTCAE v5.0 score ≤ 1 (except for alopecia and other toxic reactions that researchers believe do not affect the safety of this chemotherapy)
- According to the researchers, there are serious risks to the safety of patients or concomitant diseases that affect the completion of the study.
- Participated in clinical trials of any other drugs within 4 weeks.
- Received the same efficacy drugs(such as PEG-rhG-CSF or rhG-CSF, etc.) are still in 5 half-lives or within 28 days (whichever is shorter).
- With allergic disease or allergic constitution, and who have previously been allergic to any drug or its components in this trial.
- Active hepatitis B (HBsAg positive and HBV-DNA copy number greater than the normal limit) and / or active hepatitis C (hepatitis C virus antibody positive and HCV-RNA copy number greater than the normal limit) and / or human immunodeficiency virus antibody positive and / or Treponema pallidum antibody.
- Drug abuse. history or drug abusers
- Pregnant or lactating women
- Who have been judged by the researchers to be unsuitable for selection or who are not suitable for other reasons
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase II/III,Multi-Center,Randomized,Double-blind,Active-Controlled Trial to Compare the Efficacy , Safety and Immunogenicity of MW05 and PEG-rhG-CSF in Prophylactic Treatment for Chemotherapy-Induced Neutropenia
In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1 .
The dose of the experimental drug MW05 in phase III were determined by independent data monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 μg/kg) on the 3th day of each chemotherapy cycle.
Read the detailed description
Study Stage: Phase II/III Study Population Female patients with breast cancer will be enrolled to receive at least 4 cycles of TC chemotherapy, that is: Docetaxel 75 mg/m2 and Cyclophosphamide 600 mg/m2.
Study Design: A multi-center, randomized, open-label, active-controlled phase II/III clinical trial
- Conditions
- Breast Cancer Female
- Being tested
- MW05, PEG-rhG-CSF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MW05Drug
Also called MW05 injection
Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection
PEG-rhG-CSFDrug
Also called PEG-rhG-CSF injection
PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor
| Study group | Role | What they receive |
|---|---|---|
| MW05 300μg/kg | Experimental | Subjects will receive MW05(300 μg/kg s.c.) on day 3 of each cycle (6~10 a.m.) Receives: Drug: MW05 |
| MW05 500μg/kg | Experimental | Subjects will receive MW05(500 μg/kg s.c.) on day 3 of each cycle (6~10 a.m.) Receives: Drug: MW05 |
| PEG-rhG-CSF | Active comparator | Subjects will receive PEG-rhG-CSF(100 μg/kg s.c.) on day 3 of each cycle (6~10 a.m.) Receives: Drug: PEG-rhG-CSF |
What is being measured
The primary outcome is the main question the study is designed to answer.
The primary objective of this study will be to evaluate the efficacy of MW05 pre-filled syringe as compared to PEG-rhG-CSF standard dosing (6 mg) in the first chemotherapy cycle.
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 109/L) observed in chemotherapy cycle 1.
Measured: in cycle 1（each cycle is 21 days）
Secondary outcomes (6)
The duration of grade 4 neutropenia in cycle 2~4 assessed by ANC（ANC < 0.5 × 109/L）
The duration of grade 4 neutropenia (ANC< 0.5 × 109/L)
Measured: in cycles 2-4, in overall 3 cycles（each cycle is 21 days）
The incidence of grade 4 neutropenia in cycle 1~4 assessed by ANC（ANC < 0.5 × 109/L）
The incidence rate of grade 4 neutropenia (ANC< 0.5 × 109/L)
Measured: through study completion, in overall 4 cycles（each cycle is 21 days）
The incidence of grade 3 or 4 neutropenia in cycle 1~4 assessed by ANC（ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively）
The incidence rate of grade 3 or 4 neutropenia (ANC < 1.0 × 109/L and ANC< 0.5 × 109/L, respectively)
Measured: through study completion, in overall 4 cycles（each cycle is 21 days）
The duration of grade 3 or 4 neutropenia In cycle 1~4 assessed by ANC（ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively）
The duration of grade 3 or 4 neutropenia (ANC < 1.0 × 109/L and ANC< 0.5 × 109/L, respectively)
Measured: through study completion, in overall 4 cycles（each cycle is 21 days）
Incidence of febrile neutropenia (FN) (defined as ANC < 1.0×109/L; a single measurement of body temperature > 38.3°C or a temperature ≥ 38.0 °C sustained over 1 h)
Rate of febrile neutropenia (FN) (defined as ANC < 1.0×109/L; a single measurement of body temperature > 38.3 °C or a temperature ≥ 38.0 °C sustained over 1 h)
Measured: through study completion, in overall 4 cycles（each cycle is 21 days）
The proportion of subjects rescued by short-acting G-CSF in cycle 1~4.
The proportion of received short-acting G-CSF.
Measured: through study completion, in overall 4 cycles（each cycle is 21 days）
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Sep 2020
- Study start21 Sep 2020
- Primary completion20 Aug 2022
- Study completion5 Nov 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Breast Cancer FemaleStudies of the same condition, open and under way.
- More trials run by Mabwell (Shanghai) Bioscience Co., Ltd.The 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 2/3
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 586 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04554056
- Sponsor's protocol ID
- MW05-2020-CP301
- Status last verified
- Dec 2022
- First submitted
- 27 Jul 2020
- Last updated
- 2 Dec 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Dec 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase II/III,Multi-Center,Randomized,Double-blind,Active-Controlled Trial to Compare the Efficacy , Safety and Immunogenicity of MW05 and PEG-rhG-CSF in Prophylactic Treatment for Chemotherapy-Induced Neutropenia
- ClinicalTrials.gov ID
- NCT04554056
- Acronym / sponsor ID
- MW05-2020-CP301
- Conditions
- Breast Cancer Female
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 586 participants (actual)
- Lead sponsor
- Mabwell (Shanghai) Bioscience Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 21 Sep 2020 (actual)
- Primary completion
- 20 Aug 2022 (actual)
- Study completion
- 5 Nov 2022 (actual)
- First posted
- 18 Sep 2020 (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.
In the study, subjects will scheduled to undergo four 21-days cycles of chemotherapy treatment. Three group were treated with MW05 300 μg/kg or MW05 500 μg/kg or PEG-rhG-CSF 100 μg/kg on the 3th day of each cycle randomized 1:1:1 .
The dose of the experimental drug MW05 in phase III were determined by independent data monitoring committee (IDMC) according to the efficacy and safety of phase II. Subjects were randomly divided into two groups 1:1 to received either MW05 or PEG-rhG-CSF(100 μg/kg) on the 3th day of each chemotherapy cycle.
Detailed description
Study Stage: Phase II/III Study Population Female patients with breast cancer will be enrolled to receive at least 4 cycles of TC chemotherapy, that is: Docetaxel 75 mg/m2 and Cyclophosphamide 600 mg/m2.
Study Design: A multi-center, randomized, open-label, active-controlled phase II/III clinical trial
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| MW05 300μg/kg | Experimental | Drug: MW05Subjects will receive MW05(300 μg/kg s.c.) on day 3 of each cycle (6~10 a.m.) |
| MW05 500μg/kg | Experimental | Drug: MW05Subjects will receive MW05(500 μg/kg s.c.) on day 3 of each cycle (6~10 a.m.) |
| PEG-rhG-CSF | Active comparator | Drug: PEG-rhG-CSFSubjects will receive PEG-rhG-CSF(100 μg/kg s.c.) on day 3 of each cycle (6~10 a.m.) |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 18～70 years old female(including threshold)
- Diagnosed with breast cancer .
- Weight≥45kg.
- Patients planned to receive TC chemotherapy.
- ECOG ≤ 1
Key exclusion criteria (18 listed)
- History of other malignant tumors (skin basal cell carcinoma, skin squamous cell carcinoma and / or carcinoma in situ after radical resection can be included in the group after being cured for more than 5 years)
- Primary hematological diseases, including but not limited to myelodysplastic syndrome, aplastic anemia, sickle cell anemia and other hematological diseases that affect bone marrow hematopoiesis.
- With known central nervous system metastasis or suspected central nervous system metastasis based on clinical manifestations.
- With previous history of bone marrow transplantation and / or stem cell transplantation.
- Currently uncontrolled infections or have received systematic anti-infective therapy within 72 hours before randomization.
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 |
|---|---|---|
| MW05Also: MW05 injectionRecombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection | Drug | MW05 300μg/kg, MW05 500μg/kg |
| PEG-rhG-CSFAlso: PEG-rhG-CSF injectionPEGylated Recombinant Human Granulocyte Colony-Stimulating Factor | Drug | PEG-rhG-CSF |
Primary outcome
The primary objective of this study will be to evaluate the efficacy of MW05 pre-filled syringe as compared to PEG-rhG-CSF standard dosing (6 mg) in the first chemotherapy cycle.
Time frame: in cycle 1（each cycle is 21 days）
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 109/L) observed in chemotherapy cycle 1.
6 secondary outcomes
The duration of grade 4 neutropenia in cycle 2~4 assessed by ANC（ANC < 0.5 × 109/L）
Time frame: in cycles 2-4, in overall 3 cycles（each cycle is 21 days）
The incidence of grade 4 neutropenia in cycle 1~4 assessed by ANC（ANC < 0.5 × 109/L）
Time frame: through study completion, in overall 4 cycles（each cycle is 21 days）
The incidence of grade 3 or 4 neutropenia in cycle 1~4 assessed by ANC（ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively）
Time frame: through study completion, in overall 4 cycles（each cycle is 21 days）
The duration of grade 3 or 4 neutropenia In cycle 1~4 assessed by ANC（ANC < 1.0 × 109/L and ANC < 0.5 × 109/L, respectively）
Time frame: through study completion, in overall 4 cycles（each cycle is 21 days）
Incidence of febrile neutropenia (FN) (defined as ANC < 1.0×109/L; a single measurement of body temperature > 38.3°C or a temperature ≥ 38.0 °C sustained over 1 h)
Time frame: through study completion, in overall 4 cycles（each cycle is 21 days）
The proportion of subjects rescued by short-acting G-CSF in cycle 1~4.
Time frame: through study completion, in overall 4 cycles（each cycle is 21 days）
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 2 Dec 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing MW05 and PEG-rhG-CSF in people with Breast Cancer Female, run by Mabwell (Shanghai) Bioscience Co., Ltd. at 1 site in China.
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 12 inclusion and 18 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 2 Dec 2022. 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 China. 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 combined 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.
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?
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?
The primary objective of this study will be to evaluate the efficacy of MW05 pre-filled syringe as compared to PEG-rhG-CSF standard dosing (6 mg) in the first chemotherapy cycle. (time frame: in cycle 1（each cycle is 21 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 2 Dec 2022.