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Breast CancerPhase 3NCT04736589

Inetetamab Plus Rapamycin and Chemotherapy for HER2+ Metastatic Breast Cancer With Abnormal Activation of PAM Pathway

A Phase 3 study testing Inetetamab, Rapamycin and Pyrotinib in people with Breast Cancer, run by Peking Union Medical College at 1 site in China.

Not yet recruiting

Opening soon. The study is approved but enrolment has not started yet. Sites may already take enquiries.

Sites and contacts
Official record
Search all trials

Trial summary

This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib… Read more about this study

Who is it for?
Ages 18 to 85 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Inetetamab, Rapamycin and Pyrotinib
Could I receive a placebo?
No, everyone receives an active treatment
How many people
270 participants
Where
1 siteChina
Study dates
2 Feb 2021to 2 Feb 2027
Phase
Phase 3
Are there results?
Not yet: the study is under way

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 85 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, Aged > 18;
  • HER2-positive breast cancer are defined as immunohistochemical (IHC) testing as +++, or IHC++ with FISH testing of positive;
  • Histologically or cytologically confirmed invasive breast carcinoma with locally recurrent or radiological evidence of metastatic disease.
  • Patients with HER2-positive metastatic breast cancer who have progressed disease after trastuzumab treatment include the following four types of patients (Note: The following patients are in a parallel relationship):
  • Patients with HER2-positive breast cancer who have progressed during adjuvant trastuzumab treatment after surgery; or
  • Patients with HER2-positive breast cancer who have relapsed or metastasized after receiving adjuvant trastuzumab therapy; or
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  • HER2-positive recurrent or metastatic BC patients who have progressed after receiving at least 4 weeks of trastuzumab as first-line treatment ; or
  • HER2-positive metastatic BC patients who have never been treated have progressed after receiving at least 4 weeks of trastuzumab as first-line treatment.
  • Genetic testing shows that the PI3K/Akt/mTOR pathway related genes are mutated;
  • ECOG PS score ≤2, estimated survival time ≥6 months, and can be followed-up;
  • Patients with measurable disease as per RECIST 1.1 criteria;
  • Cardiopulmonary function is basically normal, LVEF≥50% within 4 weeks before starting treatment;
  • An adequate liver function with the following definition:
  • Total bilirubin ≤ 1.5 times the upper limit of normal value. Patients with known Gibert's disease can be included in the group if combined bilirubin ≤ 1.5 times the upper limit of normal value;
  • AST and ALT ≤2.5 times the upper limit of the normal value; if there is liver metastasis, ≤5 times the upper limit of the normal value (the normal value is the normal value specified by this clinical trial center);
  • Have sufficient baseline hematology parameters, defined as follows:
  • ANC≥1.5 x 10^3 /μL;
  • Platelet count ≥100 x 10^3/μL, if it is 75-100 x 10^3/μL, it may be included in the group, as long as the doctors believe it can be included;
  • Hemoglobin ≥9 g/dL.
  • Coagulation Indicators: International normalized ratio (INR) and activated partial thromboplastin time (aPTT) ≤ 1.5 times the upper limit of normal, unless drugs known to change INR and aPTT are used;
  • No history of serious heart, kidney and other important organs and endocrine disease;
  • Female patients of childbearing age have a negative pregnancy test and voluntarily take effective and reliable contraceptive measures;
  • The patients voluntarily signed an informed consent form.

Who cannot join

  • Anyone who has one of the following conditions cannot be selected for this trial:
  • Participated in other clinical trials within 4 weeks;
  • Have used mTOR inhibitors in the past;
  • Previous use of Pyrotinib in first-line treatment stage; previous use of lapatinib is allowed;
  • Accompanied by immunosuppressant or chronic corticosteroid medication, or more than 25% bone marrow radiotherapy within 4 weeks;
  • Symptomatic CNS metastases or evidence of leptomeningeal disease;
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  • Gastrointestinal dysfunction or gastrointestinal diseases (including active ulcers);
  • Hepatitis B or hepatitis C carriers, or other known chronic liver diseases; HIV positive;
  • Known hypersensitivity to any study medication
  • Women during pregnancy or lactation;
  • Left ventricular ejection fraction <50%; clinical manifestations of patients with obvious arrhythmia, myocardial ischemia, severe atrioventricular block, cardiac insufficiency, and severe valvular disease;
  • Any malignancy within 5 years prior to randomization, with the exception of adequately treated in-situ carcinoma of the cervix uteri, basal or squamous cell carcinoma;
  • The researchers decide that any other medical, social or psychological conditions which are inappropriate to participate in this trial.

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Fei Ma, MD contact

86-10-87788060

drmafei@126.com

Xiuwen Guan, MD contact

86-10-87788060

China1 site

  • National Cancer Center/National Clinical Research Center for Cancer/Cancer Hospital, Chinese Academy of Medical Sciences and Peking Union Medical College

    Beijing

Other trials in China

About this study

Official title: Efficacy and Safety of Inetetamab Combined With Rapamycin and Chemotherapy for HER2-positive Metastatic Breast Cancer Patients With Abnormal Activation of PI3K/Akt/mTOR Pathway After Progression on Trastuzumab.

This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib plus chemotherapy.The study aimed to access the efficacy and safety of Inetetamab combined with Rapamycin and chemotherapy in HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway.

Read the detailed description

This is a multi-center,randomized,phase 3 clinical trial. In the study, HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab are enrolled and randomized to receive the treatment of Inetetamab plus Rapamycin plus chemotherapy or Pyrotinib plus chemotherapy.The study aimed to access the efficacy and safety of Inetetamab combined with Rapamycin and chemotherapy in HER2-positive metastatic breast cancer patients with abnormal activation of PI3K/Akt/mTOR pathway after progression on trastuzumab. The primary end point is Progressive-free Survival (PFS). The secondary end points are Overall Response Rate (ORR),Overall Survival (OS),Clinical Benefit Rate (CBR) and safety.

Conditions
Breast Cancer
Being tested
Inetetamab, Rapamycin, Pyrotinib, Chemotherapy
Keywords
Breast Cancer, Inetetamab, Rapamycin, PI3K/Akt/mTOR pathway
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

    Initial dose of 8mg/kg, completed in 90 minutes IV infusion, and then 6 mg/kg over 30-90 minutes IV infusion every 3 weeks.

  • RapamycinDrug

    Oral 2mg, once a day.

  • PyrotinibDrug

    Oral 400mg, once a day.

  • ChemotherapyDrug

    Chemotherapy drugs are not limited in this trial, please refer to their instructions for specific usage.

Study groups in NCT04736589
Study groupRoleWhat they receive
Inetetamab plus Rapamycin plus ChemotherapyExperimentalDrug: Inetetamab Initial dose of 8mg/kg, completed in 90 minutes IV infusion, and then 6 mg/kg over 30-90 minutes IV infusion every 3 weeks, until disease progression (PD) or other termination criteria are met; Drug: Rapamycin Oral 2mg, once a day; Drug: Chemotherapy drugs are not limited in this trial, please refer to their instructions for specific usage.
Receives: Drug: Inetetamab; Drug: Rapamycin; Drug: Chemotherapy
Pyrotinib plus chemotherapyActive comparatorDrug:Pyrotinib Oral 400mg, once a day; Drug: Chemotherapy drugs are not limited in this trial, please refer to their instructions for specific usage.
Receives: Drug: Pyrotinib; Drug: Chemotherapy

What is being measured

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

  1. Progressive-free Survival (PFS)

    Progressive-free Survival (PFS) is defined as the time from the date of randomization to the date of first radiologically documented tumor progression or death from any cause, whichever occurs first.

    Measured: Estimated 24 months

Secondary outcomes (4)

  1. Overall Response Rate (ORR)

    Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by CT/MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.

    Measured: Estimated 24 months

  2. Overall Survival （OS）

    Overall Survival （OS）is defined as the time from date of randomization to the date of death from any cause.

    Measured: Estimated 48 months

  3. Clinical Benefit Rate (CBR)

    Clinical Benefit Rate (CBR) is defined as the percentage of participants whose best overall response, according to RECIST1.1, is either complete response (CR), a partial response (PR) or stable disease (SD) lasting for at least 24 weeks.

    Measured: Estimated 24 months

  4. Safety(AEs and SAEs)

    Adverse Events (AEs) and Serious Adverse Events (SAEs)

    Measured: From consent through 28 days following treatment completion

Timeline

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

  1. First posted3 Feb 2021
  2. Study start2 Feb 2021 (estimated)
  3. Primary completion2 Feb 2024 (estimated)
  4. Study completion2 Feb 2027 (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 3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
270 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04736589
Sponsor's protocol ID
IR-1.1
Status last verified
Jan 2021
First submitted
31 Jan 2021
Last updated
3 Feb 2021
Results posted
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing Inetetamab, Rapamycin and Pyrotinib in people with Breast Cancer, run by Peking Union Medical College 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 23 inclusion and 13 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: opening soon, as of the sponsor's last update on 3 Feb 2021. 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?

This study is still under way. Results are not available in the source record yet.

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

Contact Fei Ma, MD (86-10-87788060, drmafei@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progressive-free Survival (PFS) (time frame: Estimated 24 months). 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 NCT04736589.

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 3 Feb 2021.

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