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Breast CancerPhase 2IncreaseNCT04941885

Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer

A Phase 2 study testing Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI in people with Breast Cancer, run by 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 The sponsor has not verified this record for over two years, so it may be out of date.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

Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the important mechanisms for suppressing tumors of Trastuzumab. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab. Read more about this study

Who is it for?
Ages 18 to 75 years, women only
Conditions the study is for
Breast Cancer
What is being tested?
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI
Could I receive a placebo?
No, everyone receives an active treatment
How many people
78 participants
Where
1 siteChina
Study dates
25 Jun 2021to 1 Jul 2025
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 75 years
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Voluntarily sign the informed consent form;
  • 18-75 years old;
  • The expected survival period is ≥12 weeks;
  • Eastern Cooperative Oncology Group (ECOG) score [0-2] points;
  • The diagnosis of invasive carcinoma by histology or cytology; Estrogen receptor (ER) positive (defined as >1% nuclear ER staining); HER2 negative (defined as IHC 0 or 1+, or HER2(2+) with HER2 FISH detection no amplification);
  • Inoperable or recurrent/metastatic breast cancer patients with aromatase inhibitor treatment failure;
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  • In the state of disease progression before enrollment;
  • Measurable disease according to RECIST version 1.1 or only bone metastasis;
  • Adequate hematological, hepatic and renal function;
  • NYHA class I or II and Left ventricular ejection fraction (LVEF) ≥50%.
  • The diagnosis of invasive carcinoma by histology or cytology: Hormone receptor (HR) positive (defined as >1% nuclear estrogen receptor staining); HER2 positive (defined as IHC 3+, or HER2 FISH detection amplification);
  • In the state of disease progression before enrollment;
  • Have lesions able to and agree to perform tissue biopsy at the time requested in the study;
  • Treatment ≥1 line after recurrence/metastasis, or relapse within 12 months after completing trastuzumab-based adjuvant therapy or during trastuzumab adjuvant therapy;
  • Previously received trastuzumab for anti-HER2 therapy;
  • Measurable disease according to RECIST version 1.1.

Who cannot join

  • Allergic to the ingredients of Inetetamab, cyclophosphamide or similar drugs;
  • Concomitant diseases/conditions that is not controllable, and any other major illness that, in the investigator's judgment, will substantially increase the risk associated with the patient's participation in this study;
  • Patients who cannot accept drugs orally;
  • Women who are pregnant or breastfeeding or planning to give birth;
  • Patients with currently symptomatic brain or meningeal metastasis;
  • History of other primary malignancy;
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  • Resistant to steroidal or nonsteroidal aromatase Inhibitor;
  • Have used Inetetamab;
  • Patients with life-threatening, symptomatic, metastatic visceral disease.

Trial locations and contacts

1 site in 1 country.

Shusen Wang, MD contact

+86-13926168469

wangshs@sysucc.org.cn

Kuikui Jiang, MD contact

+86-15210589011

jiangkk@sysucc.org.cn

China1 site, 1 recruiting

  • Shusen Wang

    Guangzhou, Guangdong, 510060

    Shusen Wang, MD, +86-13926168469, wangshs@sysucc.org.cn

    Recruiting

Other trials in China

About this study

Official title: A Phase II Single-arm Clinical Trial of the Efficacy and Tolerability of Inetetamab Combined With Cyclophosphamide Metronomic Chemotherapy and Aromatase Inhibitor in Metastatic HER2+/HR+ Breast Cancer

Antibody-dependent cell-mediated cytotoxicity (ADCC) is one of the important mechanisms for suppressing tumors of Trastuzumab. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab. Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits. Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies. Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients and to explore the possible mechanisms.

Read the detailed description

Trastuzumab is a humanized monoclonal antibody, and antibody-dependent cell-mediated cytotoxicity (ADCC) is one of its important mechanisms for suppressing tumors. Pre-clinical data suggest that the ADCC effect of Inetetamab, an anti-HER2 monoclonal antibody with a modified Fc segment, is 1.11 times that of trastuzumab. Previous studies indicated that enhanced ADCC effects can be transformed into clinical benefits, but the absolute benefits are still unsatisfactory. Further improvement of ADCC effects and monoclonal antibody-induced immune responses may improve the clinical benefits. Immune induction through cyclophosphamide metronomic chemotherapy may further enhance the ADCC effect of anti-HER2 monoclonal antibodies. According to previous clinical studies, for HR-positive and HER2-positive metastatic breast cancer patients, metronomic chemotherapy combined with endocrine therapy and anti-HER2 targeted therapy may be one of the treatment options. Therefore, we conducted this study to explore the efficacy and the safety of Inetetamab combined with cyclophosphamide metronomic chemotherapy and aromatase inhibitors(AI) in the treatment of metastatic HER2-positive and HR-positive breast cancer patients, and we further exploring the possible mechanisms.

Conditions
Breast Cancer
Being tested
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI
Medical subject headings
Breast Neoplasms

What participants receive

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

  • Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AIDrug

    Each participant receives Inetetamab plus cyclophosphamide metronomic chemotherapy plus AI.

Study groups in NCT04941885
Study groupRoleWhat they receive
Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AIExperimentalEach participant receives Inetetamab(8mg/kg iv day 1 followed by 6mg/kg iv day 1, cycled every 21 days) plus cyclophosphamide metronomic chemotherapy(50mg once a day orally) plus aromatase(once a day orally).
Receives: Drug: Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI

What is being measured

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

  1. Objective response rate (ORR)

    The proportion of best overall response of either complete or partial response.

    Measured: 1 year

Secondary outcomes (6)

  1. Clinical benefit rate (CBR)

    Response and progression will be evaluated using RECIST 1.1. Evaluation will occur every 3 months till progression or termination of the study. CBR is defined as ratio of participants who have stable disease for over 24 weeks.

    Measured: 1 year

  2. Progression free survival (PFS)

    Time from the date of treatment to the date of tumor progression.

    Measured: 1 year

  3. Duration of response (DOR)

    Time from the first assessment of the tumor as complete or partial response to the first assessment as PD (Progressive Disease) or death from any cause.

    Measured: 1 year

  4. Overall survival (OS)

    Time from the date of treatment to the date of death.

    Measured: 3 years

  5. Number of Participants with Adverse Events

    Number of participants with adverse events related to the treatment.

    Measured: 1 year

  6. The quality of life

    Using Functional Assessment of Cancer therapy -Breast (FACT-B) scale. The minimum and maximum values are 0 and 144, respectively. Higher scores mean better outcome.

    Measured: 1 year

Timeline

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

  1. First posted28 Jun 2021
  2. Study start25 Jun 2021 (estimated)
  3. Primary completion1 Jul 2023 (estimated)
  4. Study completion1 Jul 2025 (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
Masking
None (open label)
Enrolment
78 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04941885
Sponsor's protocol ID
SYSU-2021
Acronym
Increase
Status last verified
Jul 2021
First submitted
25 Jun 2021
Last updated
2 Jul 2021
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Inetetamab Plus Cyclophosphamide Metronomic Chemotherapy Plus AI in people with Breast Cancer, run by 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 16 inclusion and 9 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 2 Jul 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 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 Shusen Wang, MD (+86-13926168469, wangshs@sysucc.org.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: 1 year). 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 NCT04941885.

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 2 Jul 2021.

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