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Breast CancerPhase 2NCT04681911

Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer

A Phase 2 study testing Inetetamab, Pyrotinib and Capecitabine in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University at 1 site in China.

Unknown status

Status not confirmed. The sponsor has not verified this record for over two years, so it may be out of date.

Official record
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Trial summary

HER2-targeted therapy after the failure of trastuzumab treatment has become a new difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after trastuzumab fails, showing good survival benefits. Read more about this study

Who is it for?
Ages 18 to 70 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Inetetamab, Pyrotinib and Capecitabine
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
71 participants
Where
1 siteChina
Study dates
9 Sep 2020to 9 Sep 2024
Phase
Phase 2
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

  • Subjects must meet all of the following conditions:
  • Adult female patients (age 18-70 years) with metastatic breast cancer confirmed by pathology or imaging;
  • Pathological diagnosis of HER-2 was positive (definition: immunohistochemical results were + + + or in situ hybridization results were positive);
  • Received trastuzumab treatment in the past;
  • the patients have received 1-3 treatments for metastatic breast cancer in the past;
  • According to RECIST 1.1, patients with at least one target lesion or simple bone metastasis can be evaluated;
Show all 12Show fewer
  • ECoG score of physical status was less than 2, and the expected survival time was not less than 3 months;
  • Prior treatment-related toxicity should be reduced to NCI CTCAE (version 5.0) ≤ 1 degree (except for hair loss or other toxicity which is considered as no risk to patient's safety according to the investigator's judgment) 8）LVEF≥50%；
  • 9) Sufficient functional reserve of bone marrow
  • White blood cell count (WBC) ≥ 3.0 × 10 ^ 9 / L,
  • Neutrophil count (ANC) ≥ 1.5 × 10 ^ 9 / L,
  • Platelet count (PLT) ≥ 100 × 10 ^ 9 / L 10) Previous treatment-related toxicity should be relieved as NCI CTCAE (version 5.0) ≤ 1 degree, total bilirubin (TBIL) ≤ 1.5 × upper limit of normal value (ULN), alanine aminotransferase (ALT / AST) ≤ 2.5 × ULN (liver metastasis patients ≤ 5xuln), serum creatinine ≤ 1.5 × ULN or creatinine clearance rate (CCR) ≥ 60 ml / min; 11) Be able to understand the research process, volunteer to participate in the study, and sign informed consent.

Who cannot join

  • Subjects were not allowed to participate in the study if they had any of the following conditions:
  • No trastuzumab treatment was received;
  • Have received more than 3 therapeutic regimens for metastatic breast cancer;
  • No treatment for metastatic breast cancer was received;
  • Patients who are known to be allergic to active or other components of the study drug.
  • They received radiotherapy, chemotherapy, endocrine therapy within 4 weeks before enrollment, or were participating in any clinical trials of intervention drugs;
  • Pregnant or lactating women, women of childbearing age who refused to take effective contraceptive measures during the study period.
  • Any other situation in which the researcher considers that the patient is not suitable for the study may interfere with the concomitant diseases or conditions involved in the study, or there are any serious medical barriers that may affect the safety of the subjects (e.g., uncontrollable heart disease, hypertension, active or uncontrollable infection, active hepatitis B virus infection)

Trial locations and contacts

1 site in 1 country.

Jianli Zhao contact

86-20-34070870

zhaojli5@mail.sysu.edu.cn

Ying Wang contact

86-20-34070499

wangy556@mail.sysu.edu.cn

China1 site, 1 recruiting

  • Sun Yat Sen Memorial Hospital，Sun Yat sen University

    Guangzhou, Guangdong, 510000

    Jianli Zhao, 020-34070870, zhaojli5@mail.sysu.edu.cn

    Ying Wang, 020-34070499, wangy556@mail.sysu.edu.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Single-arm Clinical Trial of Inetetamab Combined With Pyrotinib and Chemotherapy in the Treatment of HER2 Positive Metastatic Breast Cancer

HER2-targeted therapy after the failure of trastuzumab treatment has become a new difficulty and challenge. Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after trastuzumab fails, showing good survival benefits. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. Pyrotinib and Inetetamab showed excellent anti-tumor efficacy and good safety in TKI and optimized ADCC respectively. we plan to carry out a phase II single-arm clinical study to evaluate the efficacy and safety of "Inetetamab combined with Pyrotinib and chemotherapy" in the treatment of her positive metastatic breast cancer.

Read the detailed description

Trastuzumab is the first target drug for HER2 positive metastatic breast cancer, which can significantly improve the survival of patients with HER2 positive metastatic breast cancer and become the first-line standard treatment. However, the selection of second-line targeted drugs after the failure of trastuzumab treatment has become a new difficulty and challenge. Studies have shown that the ADCC effect is one of the main mechanisms of the anti-tumor effect of trastuzumab. Therefore, Inetetamab, a new antibody to optimize the ADCC effect, has become one of the second-line treatment options after trastuzumab fails, showing good survival benefits. Pyrotinib, another second-line HER2 targeted drug, is a typical representative of TKI drugs, which not only has a strong HER2 antagonistic effect but also can synergize with monoclonal antibodies to amplify the ADCC effect. As two important class 1.1 innovative drugs in China, Pyrotinib and Inetetamab showed excellent anti-tumor efficacy and good safety in TKI and optimized ADCC respectively. Considering that the current guidelines recommend the combination of multiple anti-HER2 targeted drugs, and basic research also shows that Pyrotinib and Inetetamab have a synergistic effect, we plan to carry out a phase II single-arm clinical study to evaluate the efficacy and safety of "Inetetamab combined with Pyrotinib and chemotherapy" in the treatment of her positive metastatic breast cancer, so as to provide better results for patients with HER2 positive metastatic breast cancer Treatment options!

Conditions
Breast Cancer
Being tested
Inetetamab, Pyrotinib, Capecitabine, Gemcitabine, Vinorelbine
Keywords
HER2 positive metastatic breast cancer, Inetetamab, Pyrotinib
Medical subject headings
Breast Neoplasms

What participants receive

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

  • InetetamabDrug

    Inetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle.

  • PyrotinibDrug

    Pyrotinib: 400mg, oral, every day.

  • CapecitabineDrug

    Also called xeloda or other names

    Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle

  • GemcitabineDrug

    Also called Gemzar or other names

    Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle

  • VinorelbineDrug

    Also called Navelbine or other names

    Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle

  • CarboplatinDrug

    Also called Paraplatin or other names

    Carboplatin, AUC = 6, 3-week cycle

  • Albumin paclitaxelDrug

    Also called Abraxane or other names

    Albumin paclitaxel, 100 mg/m2, weekly

  • EribulinDrug

    Also called Halaven

    Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle

Study groups in NCT04681911
Study groupRoleWhat they receive
Inetetamab Combined With Pyrotinib and ChemotherapyExperimentalInetetamab: 8mg/kg for the first dose, 6mg/kg for the following doses, every 3 weeks for one cycle. Pyrotinib: 400mg, oral, every day. Chemotherapy: the choice of physicians，as the following regimens: Capecitabine, 1000 mg/m2, d1-d14, 3-week cycle Gemcitabine, 1000 mg/m2, D1, D8, 3-week cycle Vinorelbine, 25-30 mg/m2, D1, D8, 3-week cycle Carboplatin, AUC = 6, 3-week cycle Albumin paclitaxel, 100 mg/m2, weekly Eribulin, 1.4 mg/m2, D1, D8, 3-week cycle
Receives: Drug: Inetetamab; Drug: Pyrotinib; Drug: Capecitabine; Drug: Gemcitabine; Drug: Vinorelbine; Drug: Carboplatin; Drug: Albumin paclitaxel; Drug: Eribulin

What is being measured

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

  1. Objective Response Rate，ORR

    Objective response rate assessed at 18 weeks after enrollment，that is about 6 cycles of treatment

    Measured: 18 weeks after enrollment

Secondary outcomes (6)

  1. Progression Free Survival，PFS

    The time from the beginning of treatment to the progression or death of the patient

    Measured: 2 years

  2. overall survival，OS

    The time from the beginning of treatment to the death of the patient

    Measured: 4 years

  3. Clinical Benefit Rate，CBR

    Clinical Benefit Rate assessed at 24 weeks after enrollment，that is about 8 cycles of treatment

    Measured: 24 weeks after enrollment

  4. the rate of adverse events

    The probability and severity of adverse reactions were analyzed up to 24 weeks after enrollment

    Measured: up to 24 weeks after enrollment

  5. Quality of life scale score，QoL

    The quality of life score of patients during treatment was analyzed（FACT-B）. Performance Status Rating (PSR) was demonstrated for the FACT-B total score, which is the result of the following subscale scores: SWB (the Social / family Well-Being subscale) , EWB (the Emotional Well-Being subscale), AC (Additional Concerns subscale), PWB (the Physical Well-Being subscale), FWB (the Functional Well-Being subscale)

    Measured: 1 year

  6. Exploration of biomarkers

    Objective to explore the correlation between biomarkers and the ORR. The biomarkers will be test by nest-generation sequence, which include 520 genes and tumor mutation burden, like ERBB2/TP53/PIK3CA/ERBB4/CCND1 and so on.

    Measured: the first week after the enrollment

Timeline

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

  1. First posted23 Dec 2020
  2. Study start9 Sep 2020
  3. Primary completion9 Sep 2023 (estimated)
  4. Study completion9 Sep 2024 (estimated)

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 2
Primary purpose
Treatment
Allocation
Not applicable
Intervention model
Single group
Model description
In order to improve the curative effect and prolong the survival rate, we added Inetetamab to the current second-line treatment regimen of Pyrotinib combined with chemotherapy
Masking
None (open label)
Enrolment
71 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04681911
Sponsor's protocol ID
2020-KY-125
Status last verified
Dec 2020
First submitted
25 Oct 2020
Last updated
23 Dec 2020
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: As personal information of patients is involved, we decided not to share individual participant data of patients.

Publications

  • Li X, Yang C, Wan H, Zhang G, Feng J, Zhang L, Chen X, Zhong D, Lou L, Tao W, Zhang L. Discovery and development of pyrotinib: A novel irreversible EGFR/HER2 dual tyrosine kinase inhibitor with favorable safety profiles for the treatment of breast cancer. Eur J Pharm Sci. 2017 Dec 15;110:51-61. doi: 10.1016/j.ejps.2017.01.021. Epub 2017 Jan 21.

    PubMed 28115222

  • Ma F, Ouyang Q, Li W, Jiang Z, Tong Z, Liu Y, Li H, Yu S, Feng J, Wang S, Hu X, Zou J, Zhu X, Xu B. Pyrotinib or Lapatinib Combined With Capecitabine in HER2-Positive Metastatic Breast Cancer With Prior Taxanes, Anthracyclines, and/or Trastuzumab: A Randomized, Phase II Study. J Clin Oncol. 2019 Oct 10;37(29):2610-2619. doi: 10.1200/JCO.19.00108. Epub 2019 Aug 20.

    PubMed 31430226

  • Ma F, Li Q, Chen S, Zhu W, Fan Y, Wang J, Luo Y, Xing P, Lan B, Li M, Yi Z, Cai R, Yuan P, Zhang P, Li Q, Xu B. Phase I Study and Biomarker Analysis of Pyrotinib, a Novel Irreversible Pan-ErbB Receptor Tyrosine Kinase Inhibitor, in Patients With Human Epidermal Growth Factor Receptor 2-Positive Metastatic Breast Cancer. J Clin Oncol. 2017 Sep 20;35(27):3105-3112. doi: 10.1200/JCO.2016.69.6179. Epub 2017 May 12.

    PubMed 28498781

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inetetamab, Pyrotinib and Capecitabine in people with Breast Cancer, run by Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University 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 8 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: status not confirmed, as of the sponsor's last update on 23 Dec 2020. 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Results are not available in the source record.

How can a doctor refer a patient or contact the research team?

Contact Jianli Zhao (86-20-34070870, zhaojli5@mail.sysu.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Objective Response Rate，ORR (time frame: 18 weeks after enrollment). 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 NCT04681911, which also lists 3 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 23 Dec 2020.

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