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HER2-positive Early Breast CancerPhase 3NCT03989037

A Study Of SIBP-01 Or CN-Trastuzumab Plus Docetaxel And Carboplatin In HER2 Positive Breast Cancer

A Phase 3 study testing SIBP-01, Herceptin and Docetaxel in people with HER2-positive Early Breast Cancer, run by Shanghai Institute Of Biological Products at 1 site in China.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel and Carboplatin in patients with operable HER2 positive, with early or locally advanced… Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
HER2-positive Early Breast Cancer
What is being tested?
SIBP-01, Herceptin and Docetaxel
Type of treatment
Injection or infusion
Could I receive a placebo?
No, everyone receives an active treatment
How many people
580 participants
Where
1 siteChina
Study dates
27 Jun 2019to 26 Apr 2023
Phase
Phase 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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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;
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  • 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.

Trial locations and contacts

1 site in 1 country.

China1 site

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200032

Other trials in China

About this study

Official title: 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

The study will compare PK, efficacy, safety, and immunogenicity of SIBP-01 (Trastuzumab Biosimilar) in combination with Docetaxel and Carboplatin versus Herceptin® (CN-Trastuzumab) approved in the CN in combination with Docetaxel and Carboplatin in patients with operable HER2 positive, with early or locally advanced HER2-positive breast cancer. The hypothesis to be tested in this study is the tpCR of patients with Cycle 6 of SIBP-01 is similar to CN-approved trastuzumab, using a 90% bilateral confidence interval between 0.74 and 1.5.

Being tested
SIBP-01, Herceptin, Docetaxel, Carboplatin

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • SIBP-01Drug

    Also called Herceptin Biosimilar

    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

  • HerceptinDrug

    Also called Trastuzumab

    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

  • DocetaxelDrug

    Also called Docetaxel Injection

    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;

  • CarboplatinDrug

    Also called PARAPLATIN®，Carboplatin Injection

    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;

Study groups in NCT03989037
Study groupRoleWhat they receive
SIBP-01 & Docetaxel & CarboplatinExperimentalSIBP-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
Receives: Drug: SIBP-01; Drug: Docetaxel; Drug: Carboplatin
Herceptin & Docetaxel & CarboplatinActive comparatorHerceptin→ Docetaxel→ Carboplatin: injection, every 3 weeks for 18 weeks; Herceptin: first dose 8mg/kg, then 6mg/kg; Docetaxel: dose 75mg/m2; Carboplatin: dose AUC6
Receives: Drug: Herceptin; Drug: Docetaxel; Drug: Carboplatin

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Total pathologic complete response (tpCR)

    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)

    Measured: at the end of Cycle 6(each cycle is 3 weeks)

Secondary outcomes (3)

  1. Breast pathologic complete response (bpCR)

    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.

    Measured: at the end of Cycle 6(each cycle is 3 weeks)

  2. Proportion of patients with steady-state trough concentration (Ctrough, ss) > 20 μg/mL

    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

    Measured: after 5 cycles of treatment ( before cycle 6, each cycle is 3 weeks)

  3. PK Evaluation After Multi-Dose Administration

    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.

    Measured: Cycles 1 through 6 ( each cycle is 3 weeks )

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted18 Jun 2019
  2. Study start27 Jun 2019
  3. Primary completion26 Apr 2023
  4. Study completion26 Apr 2023

Resources

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
Model description
Multi-center, randomized, single-blind, positive drug parallel controlled equivalence clinical trial.
Masking
Double blind
Who is masked
Participant, Outcomes assessor
Enrolment
580 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03989037
Sponsor's protocol ID
SIBP-01-3
Status last verified
Dec 2023
First submitted
14 Jun 2019
Last updated
27 Dec 2023
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

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.

    PubMed 28547525

  • 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.

    PubMed 30002437

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing SIBP-01, Herceptin and Docetaxel in people with HER2-positive Early Breast Cancer, run by Shanghai Institute Of Biological Products 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 21 inclusion and 17 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 27 Dec 2023. 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 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?

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?

Total pathologic complete response (tpCR) (time frame: at the end of Cycle 6(each cycle is 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 NCT03989037, which also lists 2 linked publications.

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 27 Dec 2023.

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