Clinical Trials Logo

Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04554056
Other study ID # MW05-2020-CP301
Secondary ID
Status Completed
Phase Phase 2/Phase 3
First received
Last updated
Start date September 21, 2020
Est. completion date November 5, 2022

Study information

Verified date December 2022
Source Mabwell (Shanghai) Bioscience Co., Ltd.
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 . 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.


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


Recruitment information / eligibility

Status Completed
Enrollment 586
Est. completion date November 5, 2022
Est. primary completion date August 20, 2022
Accepts healthy volunteers No
Gender Female
Age group 18 Years to 70 Years
Eligibility Inclusion Criteria: 1. 18~70 years old female(including threshold) 2. Diagnosed with breast cancer . 3. Weight=45kg. 4. Patients planned to receive TC chemotherapy. 5. ECOG = 1 6. Estimated survival time = 3 months, and could received at least 4 cycles chemotherapy treatment. 7. Have suitable organs and hematopoietic function 8. ECG examination is normal or abnormal has no clinical significance. 9. B-ultrasound examination of abdomen showed no obvious abnormality of spleen. 10. Willing to sign the informed consent form and able to comply with protocol requirements. 11. 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. - Exclusion Criteria: 1. 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) 2. Primary hematological diseases, including but not limited to myelodysplastic syndrome, aplastic anemia, sickle cell anemia and other hematological diseases that affect bone marrow hematopoiesis. 3. With known central nervous system metastasis or suspected central nervous system metastasis based on clinical manifestations. 4. With previous history of bone marrow transplantation and / or stem cell transplantation. 5. Currently uncontrolled infections or have received systematic anti-infective therapy within 72 hours before randomization. 6. Serious chronic diseases of important organs such as kidney and liver. 7. 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 8. Severe diabetes (such as fundus disease or diabetic foot), or blood sugar is still not well controlled after active treatment. 9. 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) 10. 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) 11. According to the researchers, there are serious risks to the safety of patients or concomitant diseases that affect the completion of the study. 12. Participated in clinical trials of any other drugs within 4 weeks. 13. 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). 14. With allergic disease or allergic constitution, and who have previously been allergic to any drug or its components in this trial. 15. 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. 16. Drug abuse. history or drug abusers 17. Pregnant or lactating women 18. Who have been judged by the researchers to be unsuitable for selection or who are not suitable for other reasons

Study Design


Related Conditions & MeSH terms


Intervention

Drug:
MW05
Recombinant (yeast secreted) human serum albumin-human granulocyte colony stimulating factor (I) fusion protein injection
PEG-rhG-CSF
PEGylated Recombinant Human Granulocyte Colony-Stimulating Factor

Locations

Country Name City State
China Fudan University Affiliated Cancer Hospital Shanghai

Sponsors (1)

Lead Sponsor Collaborator
Mabwell (Shanghai) Bioscience Co., Ltd.

Country where clinical trial is conducted

China, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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. in cycle 1(each cycle is 21 days)
Secondary 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) in cycles 2-4, in overall 3 cycles(each cycle is 21 days)
Secondary 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) through study completion, in overall 4 cycles(each cycle is 21 days)
Secondary 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) through study completion, in overall 4 cycles(each cycle is 21 days)
Secondary 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) through study completion, in overall 4 cycles(each cycle is 21 days)
Secondary 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) through study completion, in overall 4 cycles(each cycle is 21 days)
Secondary The proportion of subjects rescued by short-acting G-CSF in cycle 1~4. The proportion of received short-acting G-CSF. through study completion, in overall 4 cycles(each cycle is 21 days)
See also
  Status Clinical Trial Phase
Completed NCT03080623 - Ultrasound-based Diagnostic Model for Differentiating Malignant Breast Lesion From Benign Lesion
Completed NCT05527769 - Pain and Functional Recovery After Mastectomy and IBR by Implant: Prepectoral Versus Subpectoral Technique
Completed NCT06376578 - Exercise Interventions for Improving Health in Breast Cancer Survivors N/A
Completed NCT03004534 - A Study to Evaluate Changes in Human Breast Cancer Tissue Following Short-Term Use of Darolutamide Early Phase 1
Recruiting NCT05020574 - Microbiome and Association With Implant Infections Phase 2
Active, not recruiting NCT06277141 - The Vitality Mammography Messaging Study N/A
Completed NCT03270111 - High Physical Activity During a Weight Loss Intervention for Breast Cancer Survivors and High Risk Women N/A
Completed NCT03555227 - USG PECS vs LIA for Breast Cancer Surgery N/A
Active, not recruiting NCT03917082 - Limited Adjuvant Endocrine Therapy for Low Risk Breast Cancer Phase 2
Recruiting NCT05561842 - Tablet-based Mobile Health Ultrasound for Point-of-care Breast Cancer Diagnosis in Nigeria (Mobile Health: Technology and Outcomes in Low and Middle-Income Countries)
Active, not recruiting NCT03127995 - Hypofractionated vs Standard Radiotherapy in Breast Cancer With an Indication for Regional Lymph Node Irradiation About Lymphedema Occurrence N/A
Active, not recruiting NCT02237469 - Prone Breast Radiotherapy Treatment Planning Observational Study
Completed NCT01204125 - Two Regimens of SAR240550/Weekly Paclitaxel and Paclitaxel Alone as Neoadjuvant Therapy in Triple Negative Breast Cancer Patients Phase 2
Recruiting NCT04565054 - Adjuvant Therapy With Abemaciclib + SOC ET vs. SOC ET in Clinical or Genomic High Risk, HR+/HER2- EBC Phase 3
Not yet recruiting NCT06412133 - Conversations in Light and Shadow: Assessing Phototherapy's Impact on Breast Cancer Patients N/A
Recruiting NCT03956641 - Evolution of the Physical Condition in Treated Cancer Patients N/A
Recruiting NCT06087120 - Investigate the Prognostic and Predictive Value of ctDNA During Neoadjuvant Chemotherapy for Breast Cancer.
Recruiting NCT06058936 - Exercises Using Virtual Reality on Cancer Patients N/A
Completed NCT03470935 - Non-interventional Study Evaluating Gynecological Impact of Diagnosis and Treatment of Breast Cancer in Patients Younger
Recruiting NCT06025604 - ACTIVPROSEIN : Professional Activity After Breast Cancer