- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03989037
A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer
A Phase III, Randomized, Single-blind Study Comparing the Efficacy, Safety, and Immunogenicity of SIBP-01 and CN-Trastuzumab Combination With Docetaxel and Carboplatin in Patients With Early or Locally Advanced Her2 Positive Breast Cancer
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Contact
- Name: Aidong QU, phD
- Phone Number: +86-021-62800991
- Email: quaidong1@sinopharm.com
Study Locations
-
-
Shanghai
-
Shanghai, Shanghai, China, 200032
- Fudan University Shanghai Cancer Center
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Those voluntarily signing the informed consent form, understanding the study and willing to follow all testing procedures;
- Females aged ≥ 18 years and ≤ 75 years (at the date of signing the informed consent form);
- Patients diagnosed with early (T2-3, N0-1, M0) or locally advanced (T2-3, N2 or N3, M0) invasive breast cancer histologically;
- Patients with HER2-positive breast cancer: HER2 detection is based on the Chinese Breast Cancer HER2 Detection Guidelines (2019 Edition), the immunohistochemistry (IHC) method is used to detect the expression level of HER2 protein, and the in situ hybridization (ISH) method is used to detect the HER2 gene amplification level. ISH includes fluorescence in situ hybridization (FISH) and bright-field in situ hybridization. The common bright-field in situ hybridization method includes chromogenic in situ hybridization (CISH) and silver-enhanced in situ hybridization (SISH);The HER2-positive criterion is: IHC detection +++, or IHC++, and further in situ hybridization confirms that HER2 gene amplification is positive;
- Those planning to receive final surgical resection of breast cancer, i.e. breast-conserving surgery or total mastectomy, sentinel node (SN) biopsy or axillary lymph node dissection (ALND);
- Those planning to receive neoadjuvant chemotherapy;
- Those with the maximum primary tumor diameter of > 2cm determined by the standard evaluation method of study center (MRI);
- Patients with performance status score of 0 or 1 by the US Eastern Cooperative Oncology Group (ECOG);
Those with left ventricular ejection fraction (LVEF) of ≥ 55% within 4 weeks prior to randomized enrollment; 10) Those with suitable organs and hematopoietic functions, without significant abnormality in the following laboratory examinations:
- Absolute neutrophil count (NEUT#) ≥1.5×109/L;
- Absolute white blood cell count (WBC) ≥ 3.0 × 109/L;
- Platelet ≥90×109/L;
- Hemoglobin ≥90g/L;
- Serum creatinine ≤1.5 x upper limit of normal (ULN);
- AST and ALT values ≤ 1.5 x ULN;
- Serum total bilirubin (TBIL) ≤ 1.5 x ULN;
- International normalized ratio (INR) ≤ 1.5 x ULN, or activated partial thromboplastin time (APTT) ≤ 1.5 x ULN (except for subjects undergoing anticoagulation therapy).
(The above laboratory examinations are subject to the normal values of each clinical research center)
- Female patients without menopause or surgical sterilization: they agree to practice abstinence or effective contraception during treatment and at least 7 months after the last administration in the study treatment.
Women at childbearing age who have undergone surgical sterilization (including hysterectomy, bilateral oophorectomy or total hysterectomy) or have been menopausal (defined as having no menstruation for more than 12 months without medical reason) are considered as having no possibility of pregnancy.
Throughout the clinical trial, women with the possibility of pregnancy are willing to practice medically accepted, effective contraception, including intrauterine contraceptive device.
Exclusion Criteria:
- Pregnant or lactating women, and patients with positive baseline pregnancy test; women of childbearing age who do not agree to practice abstinence or effective contraception during the study period and within 7 months after the last administration;
- Those with a clear history of drug allergy, especially those with prior severe allergic reaction to macromolecular protein preparation/monoclonal antibody, or to any of the test drug components (NCI-CTCAE 5.0 greater than grade 3);
- Patients with bilateral breast cancer or inflammatory breast cancer;
- Patients with (metastatic) breast cancer Stage IV;
- Those with a history of congestive heart failure, unstable angina, arrhythmia or myocardial infarction;
- Those with other invasive tumors (including second primary breast cancer) that might affect the result evaluation and protocol compliance; however, subjects who are cured with a disease-free survival of at least 5 years may be enrolled;
- Patients with breast cancer who have previously received chemotherapy, endocrine therapy, or anti-HER2 biotherapy, or have received breast surgery (except for diagnostic biopsy of primary breast cancer);
- Those with known, uncontrolled, active bacterial, viral, fungal, mycobacterial, parasitic or other infections (excluding nail bed fungal infection) or with any significant systemic infection event that required intravenous antibiotic treatment or hospitalization (except for neoplastic fever) within 4 weeks prior to enrollment);
- Those with any positive HIV antibody or treponema pallidum antibody;
- Those with active hepatitis B (hepatitis B virus DNA titer is above the lower limit of normal);
- Those with existing, sudden lung disease, interstitial lung disease, pneumonia or pulmonary fibrosis, except for local interstitial pneumonia induced by radiotherapy;
- Those with a prior history of drug abuse, alcohol abuse or drug addiction;
- Those with a clear history of neurological or mental disease and with poor compliance, such as epilepsy and dementia;
- Those with a major surgical operation or infusion of blood or blood components 4 weeks prior to the clinical trial;
- Those with blood loss or donation of more than 400 ml within the 2 months prior to the clinical trial;
- Those who have participated in other clinical trials 3 months prior to this clinical trial;
- Those with reduced possibility of enrollment (e.g. weakness) or non-compliance tendency during the study period, or with other diseases that might complicate enrollment as judged by the investigator.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: SIBP-01 & Docetaxel & Carboplatin
SIBP-01→ Docetaxel→ Carboplatin: injection, every 3 weeks for 18 weeks; SIBP-01: first dose 8mg/kg, then 6mg/kg; Docetaxel: dose 75mg/m2; Carboplatin: dose AUC6
|
IBP-01: injection; strength: 150mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles
Other Names:
Docetaxel: injection; dose 75mg/m2, 75mg/m2 once every 3 weeks (intravenous infusion, not less than 60 minutes, on the 1st day of each cycle), totaling 6 cycles;
Other Names:
Carboplatin: injection; dose AUC6, AUC6 once every 3 weeks (intravenous infusion, not less than 30 minutes, on the 1st day of each cycle), totaling 6 cycles;
Other Names:
|
Active Comparator: Herceptin & Docetaxel & Carboplatin
Herceptin→ Docetaxel→ Carboplatin: injection, every 3 weeks for 18 weeks; Herceptin: first dose 8mg/kg, then 6mg/kg; Docetaxel: dose 75mg/m2; Carboplatin: dose AUC6
|
Docetaxel: injection; dose 75mg/m2, 75mg/m2 once every 3 weeks (intravenous infusion, not less than 60 minutes, on the 1st day of each cycle), totaling 6 cycles;
Other Names:
Carboplatin: injection; dose AUC6, AUC6 once every 3 weeks (intravenous infusion, not less than 30 minutes, on the 1st day of each cycle), totaling 6 cycles;
Other Names:
Herceptin: injection; strength: 440mg; first dose 8mg/kg (intravenous infusion, not less than 90 minutes, on the 1st day of each cycle), then 6mg/kg once every 3 weeks, totaling 6 cycles
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Total pathologic complete response (tpCR)
Time Frame: at the end of Cycle 6(each cycle is 3 weeks)
|
Total Pathologic Complete Response (tpCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes(ypT0/is, ypN0).
Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response..The tpCR was assessed by the Independent Response Evaluation Committee (IREC)
|
at the end of Cycle 6(each cycle is 3 weeks)
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Breast pathologic complete response (bpCR)
Time Frame: at the end of Cycle 6(each cycle is 3 weeks)
|
Pathologic Complete Response (pCR) Defined as the Absence of Invasive Neoplastic Cells in the Breast and Lymph Nodes(ypT0/is).
Following surgery after treatment completion, tumors were assessed as Complete Pathological Response, Partial Pathological Response, or No Pathological Response.
|
at the end of Cycle 6(each cycle is 3 weeks)
|
Proportion of patients with steady-state trough concentration (Ctrough, ss) > 20 μg/mL
Time Frame: after 5 cycles of treatment ( before cycle 6, each cycle is 3 weeks)
|
proportion of patients with Ctrough, ss> 20 μg/mL after 5 cycles of administration (before cycle 6) accounting for all subjects with PK blood samples collected in each treatment group
|
after 5 cycles of treatment ( before cycle 6, each cycle is 3 weeks)
|
PK Evaluation After Multi-Dose Administration
Time Frame: Cycles 1 through 6 ( each cycle is 3 weeks )
|
Samples of blood were taken pre-dose on Cycles 1, 2, 3, 4, 5, and 6, and at 0, 2, 4, 8, 72, 168, 336 hour post dose on Cycles 5 and 21 days post dose on cycle 6 for pharmacokinetic evaluation.
|
Cycles 1 through 6 ( each cycle is 3 weeks )
|
Collaborators and Investigators
Collaborators
Investigators
- Principal Investigator: Fudan University Shanghai Cancer Center, Fudan University
- Study Director: Shanghai Institute Of Biological Products Co., Ltd, SINOPHARM
Publications and helpful links
General Publications
- Sugitani I, Ueda S, Sakurai T, Shigekawa T, Hirokawa E, Shimada H, Takeuchi H, Matsuura K, Misumi M, Fujiuchi N, Takahashi T, Hasebe T, Osaki A, Saeki T. Neoadjuvant chemotherapy with trastuzumab, docetaxel, and carboplatin administered every 3 weeks for Japanese women with HER2-positive primary breast cancer: efficacy and safety. Int J Clin Oncol. 2017 Oct;22(5):880-886. doi: 10.1007/s10147-017-1136-8. Epub 2017 May 25.
- Lammers PE, Dank M, Masetti R, Abbas R, Hilton F, Coppola J, Jacobs I. Neoadjuvant PF-05280014 (a potential trastuzumab biosimilar) versus trastuzumab for operable HER2+ breast cancer. Br J Cancer. 2018 Aug;119(3):266-273. doi: 10.1038/s41416-018-0147-1. Epub 2018 Jul 13.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Estimated)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- SIBP-01-3
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
product manufactured in and exported from the U.S.
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on HER2-positive Early Breast Cancer
-
Hoffmann-La RocheCompletedHER2-Positive Metastatic Breast Cancer | HER2-Negative Metastatic Breast Cancer | Locally Advanced or Early Breast CancerUnited States
-
Peking University People's HospitalRecruitingHER2-positive Early Breast CancerChina
-
Hoffmann-La RocheActive, not recruiting
-
Fudan UniversityRecruitingHER2 Positive Early Breast CancerChina
-
AstraZenecaDaiichi SankyoRecruitingBreast Cancer | Breast Neoplasms | HER2-positive Early Breast CancerChina, Russian Federation, United States, Thailand, Bulgaria, India, Peru, Austria, Saudi Arabia, Canada, Italy, Korea, Republic of, Spain, Brazil, Japan, Philippines, Poland, Taiwan, Germany
-
Renske AltenaTerminatedHER2-positive Breast Cancer | Early-stage Breast CancerSweden
-
Peking Union Medical College HospitalRecruitingHER2-positive Breast Cancer | Early-stage Breast CancerChina
-
Memorial Sloan Kettering Cancer CenterGlaxoSmithKlineCompletedHER2-Positive Early Stage Breast CancerUnited States
-
Spanish Breast Cancer Research GroupPierre Fabre Laboratories; Puma Biotechnology, Inc.RecruitingHER2 Positive Breast Cancer | Hormone Receptor Positive | Early-stage Breast CancerSpain
-
Hoffmann-La RocheCompletedHER2-Positive Early Breast CancerUnited States, Finland, Hong Kong, Panama, Portugal, Spain, Mexico, Sweden, Brazil, Serbia, Argentina, Lebanon, Cuba, Qatar, Saudi Arabia, Chile, Jordan
Clinical Trials on SIBP-01
-
Livzon Pharmaceutical Group Inc.Active, not recruiting
-
Zucara Therapeutics Inc.RecruitingType 1 Diabetes Mellitus With HypoglycemiaUnited States, Canada
-
Ixchelsis LimitedCompletedPremature EjaculationUnited States
-
Enterin Inc.TerminatedParkinson Disease | ConstipationUnited States
-
Shanghai Hongyitang Biopharmaceutical Technology...Completed
-
Zhongmou TherapeuticsRecruitingX-linked RetinoschisisChina
-
BioPharmX, Inc.CompletedAcne VulgarisUnited States
-
Enterin Inc.CompletedParkinson Disease | ConstipationUnited States
-
Hokkaido University HospitalJapan Agency for Medical Research and DevelopmentRecruiting
-
Valerio TherapeuticsRecruitingBreast Cancer | Prostate Cancer | Advanced or Metastatic Solid Tumors | Recurrent Ovarian CancerUnited States