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HER2-negative Breast Cancer Brain MetastasesPhase 2NCT06418594

Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis

A Phase 2 study testing Adebrelimab, Apatinib and Etoposide in people with HER2-negative Breast Cancer Brain Metastases, run by Beijing 302 Hospital at 1 site in China.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

Some studies have shown that approximately 15% of patients with advanced hormone receptor (HR) positive breast cancer and 1/3 of triple negative breast cancer will develop brain metastasis. At present, there is no unified drug treatment standard for HER2-negative breast cancer brain metastasis (BCBM). Read more about this study

Who is it for?
Ages 18 years and older, women only
What is being tested?
Adebrelimab, Apatinib and Etoposide
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
30 participants
Where
1 siteChina
Study dates
10 Oct 2024to 31 Dec 2026
Phase
Phase 2
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 years and older
  • Women only
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Female, aged ≥18 years
  • Expected survival time ≥3 months.
  • Histologically or cytologically confirmed HER2-negative (IHC 0 or 1+; or IHC 2+ ISH negative) locally recurrent or metastatic disease
  • New brain metastasis or brain metastasis progression after treatment
  • HR+ advanced breast cancer with prior CDK4/6 inhibitor treatment failure or the investigator deems unsuitable for CDK4/6 inhibitors
  • At least one intracranial measurable lesion as defined by RECIST V1.1 criteria；
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  • ECOG PS 0-2；
  • Patients must have the ability to swallow oral medication；
  • Prior WBRT, stereotactic radiosurgery, and surgical resection are allowed；
  • Organ function levels are basically normal, and the investigator believes that the study drug can be applied：
  • Voluntarily join this study, sign the informed consent, have good compliance, and are willing to cooperate with follow-up

Who cannot join

  • Urgent need for local treatment of brain metastasis
  • Immunohistochemistry HER2 positive (IHC 3 or IHC 2 ISH amplification)
  • Previously treated with Apatinib, Avelumab, or VP-16；
  • Severe dysfunction of important organs such as the heart, liver, or kidneys；
  • Inability to swallow, chronic diarrhea, and intestinal obstruction, with multiple factors affecting drug administration and absorption；
  • Participants diagnosed with any other malignant tumor within 5 years before this study, excluding non-melanoma skin cancer that has undergone radical treatment. Basal cell or squamous cell skin cancer or cervical carcinoma in situ and thyroid papillary carcinoma。
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  • Patients who allergy to any component of the drugs in this protocol; patients with history of immunodeficiency, including HIV positive, HCV, active hepatitis B, or other acquired or congenital immunodeficiency diseases, or history of organ transplantation
  • History of any cardiac disease, including: (1) arrhythmia requiring medication or clinically significant; (2) myocardial infarction; (3) heart failure; (4) any other cardiac disease judged by the investigator to be unsuitable for participation in this trial, etc.
  • Pregnant or lactation female patients; females of childbearing age with a positive baseline pregnancy test or unwilling to take effective contraceptive measures during the entire trial period；
  • According to the investigator's judgment, there are severe accompanying diseases that endanger the patient's safety or affect the completion of the study (including but not limited to uncontrolled severe hypertension, severe diabetes, active infection, etc.).

Trial locations and contacts

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

Jinmei Zhou, Doctor contact

+86-010-66947250

jinzhu2714@sina.com

China1 site, 1 recruiting

  • The Fifth Medical Center of PLA General Hospital

    Beijing, Beijing Municipality, 100071

    Tao Wang, 01066947250, wangtaotg@163.com

    Recruiting

Other trials in China

About this study

Official title: Adebrelimab Plus Apatinib and Etoposide for the Treatment of HER2-Negative Breast Cancer Brain Metastasis: A Phase II Study

Some studies have shown that approximately 15% of patients with advanced hormone receptor (HR) positive breast cancer and 1/3 of triple negative breast cancer will develop brain metastasis. At present, there is no unified drug treatment standard for HER2-negative breast cancer brain metastasis (BCBM). The evidence of single traditional chemotherapy drug as the main treatment of brain metastasis is not sufficient. Some exploratory studies on HER2-negative BCBM have shown that the central nervous system objective response rate (CNS-ORR) of anti-angiogenic drugs combined with chemotherapy is around 55%-80%。 Adebrelimab (a humanized PD-L1 monoclonal antibody) specifically blocks the binding of PD-1 and PD-L1, terminates the immunosuppressive signal produced by T cells, and makes T cells re-recognize tumor cells and kill them, thereby inhibiting tumor growth. In China, Adebelizumab has been approved for using in combination with chemotherapy as a first-line treatment for extensive stage small cell lung cancer. Apatinib (a small molecule VEGFR tyrosine kinase inhibitor) mainly plays an anti-angiogenic effect in the treatment of malignant tumors by inhibiting VEGFR. Apatinib has been approved monotherapy for advanced gastric adenocarcinoma or gastroesophageal junction adenocarcinoma that has progressed or relapsed after at least two systematic chemotherapies, advanced liver cancer that has failed or is intolerable after at least first-line systematic treatment, and first-line treatment in patients with unresectable or metastatic hepatocellular carcinoma combined with camrelizumab.

Due to the lack of effective drug therapy for HER2-negative BCBM, a variety of treatment combinations are still being explored. We hypothesized that adebrelimab plus apatinib and etoposide is an explorable and effective treatment for HER2- negative BCBM.

Being tested
Adebrelimab, Apatinib, Etoposide

What participants receive

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

  • AdebrelimabDrug

    Adebrelimab: 1200mg, ivgtt, administered on the first day of each cycle, with a cycle of 21 days

  • ApatinibDrug

    Also called Apatinib Mesylate Tablets

    Apatinib: 250 mg, oral, once daily, continuous use, with a cycle of 21 days

  • EtoposideDrug

    Also called VP-16

    Etoposide: 50mg/day, oral, administered on days 1-14 of each cycle, with a cycle of 21 days

Study groups in NCT06418594
Study groupRoleWhat they receive
Adebrelimab+Apatinib+EtoposideExperimentalAdebrelimab: 1200mg， ivgtt，administered on the first day of each cycle, with a cycle of 21 days. Apatinib: 250 mg, oral, once daily, continuous use, with a cycle of 21 days. Etoposide: 50mg/day, oral, administered on days 1-14 of each cycle, with a cycle of 21 days.
Receives: Drug: Adebrelimab; Drug: Apatinib; Drug: Etoposide

What is being measured

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

  1. CNS-ORR

    Central nervous system objective response rate (CNS-ORR), as assessed according to the RANO-BM criteria

    Measured: 2 months

Secondary outcomes (7)

  1. CNS-PFS

    CNS progression-free survival

    Measured: 1 Year

  2. Extracranial objective response rate

    According to recist1.1 standard, the proportion of patients whose extracranial best remission was CR or PR accounted for the total number of evaluable patients

    Measured: 2 Years

  3. Extracranial progression-free survival

    The time to the date of first documented progression or date of death from any cause, whichever came first

    Measured: 2 Years

  4. OS

    The time from the beginning of treatment to the time of death caused by any cause

    Measured: 3 Years

  5. CBR

    Clinical benefit rate: CR+PR+SD≥6 months

    Measured: 2 Years

  6. DoR

    The time from the beginning of CR or PR to the time when the tumor was first evaluated as PD or any cause of death.

    Measured: 2 Years

  7. Safety

    Adverse events (AE), serious adverse events (SAE), and immune-related adverse events (irAE), in accordance with the NCI-CTC AE version 5.0 criteria. AE recorded from infromed consent to 28 days after treatment completion.

    Measured: AE recorded from infromed consent to 28 days after 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 posted17 May 2024
  2. Study start10 Oct 2024
  3. Primary completion30 Nov 2025 (estimated)
  4. Study completion31 Dec 2026 (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
This study adopts a single-arm, open-label design, planning to enroll 30 patients with HER2-negative breast cancer brain metastasis.
Masking
None (open label)
Enrolment
30 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT06418594
Sponsor's protocol ID
MA-BC-II-070
Status last verified
Dec 2024
First submitted
13 May 2024
Last updated
10 Dec 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Adebrelimab, Apatinib and Etoposide in people with HER2-negative Breast Cancer Brain Metastases, run by Beijing 302 Hospital 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 11 inclusion and 10 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: looking for participants now, as of the sponsor's last update on 10 Dec 2024. 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?

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 Jinmei Zhou, Doctor (+86-010-66947250, jinzhu2714@sina.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

CNS-ORR (time frame: 2 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 NCT06418594.

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 10 Dec 2024.

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