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HER2-negative Breast CancerPhase 2NCT03575065

Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China

A Phase 2 study testing BGB-290 in people with HER2-negative Breast Cancer, run by BeiGene at 20 sites 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

This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite standard therapy, or for which no standard therapy exists. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
HER2-negative Breast Cancer
What is being tested?
BGB-290
Type of treatment
Pill or oral medicine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
88 participants
Where
20 sitesChina
Study dates
22 Jun 2018to 14 Apr 2021
Phase
Phase 2
Are there results?
Yes, posted in the registrySummary in the doctors' view

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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Confirmed deleterious or suspected deleterious germline BRCA1 or BRCA2 mutation
  • Locally advanced or metastatic breast cancer despite standard therapy and the following:
  • Histologically or cytologically confirmed HER2(-) breast cancer (TNBC or estrogen receptor-positive and/or PR+)
  • ≤ 2 prior lines of chemotherapy in advanced or metastatic setting
  • Prior platinum therapy allowed as long as no disease progression while on treatment, or if given in neoadjuvant/adjuvant setting with ≥ 6 months from last platinum to relapse
  • Prior therapy with an anthracycline and/or a taxane in neoadjuvant/adjuvant or metastatic setting
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  • Archival tumor tissues will be collected from all patients, if available
  • For HR(+)/HER2(-) breast cancer only: patients must have received and progressed on at least one endocrine therapy either in adjuvant or metastatic setting, or have disease that the treating physician believes to be inappropriate for endocrine therapy
  • Measurable disease as defined per RECIST, version 1.1
  • Eastern Cooperative Oncology Group (ECOG) performance status ≤ 1
  • Adequate hematologic and organ function

Who cannot join

  • Unresolved acute effects of prior therapy of ≥ Grade 2
  • Prior treatment with a poly[ADP-ribose] polymerase (PARP) inhibitor
  • Chemotherapy, radiotherapy, biologic therapy, immunotherapy, investigational agent, anticancer Chinese medicine, or anticancer herbal remedies ≤ 14 days (or ≤ 5 half lives, if applicable, whichever is shorter) prior to Day 1 of Cycle 1
  • Major surgical procedure, open biopsy, or significant traumatic injury ≤ 14 days prior to Day 1 of Cycle 1, or anticipation of need for major surgical procedure during the course of the study
  • Diagnosis of myelodysplastic syndrome (MDS)
  • Other diagnosis of malignancy
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  • Untreated and/or active brain metastases.
  • Active infection requiring systemic treatment, active viral hepatitis, or active tuberculosis
  • Clinically significant cardiovascular disease
  • Pregnancy or nursing
  • Known history of intolerance to the excipients of the BGB-290 capsule

Trial locations and contacts

20 sites in 1 country.

20 sites in 1 country

China20 sites

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • The First Hospital of Jilin University

    Changchun, Jilin, 130021

  • The Second Hospital of Jilin University

    Changchun, Jilin, 130022

  • Xiangya Hospital of Central South University

    Changsha, Hunan, 410008

  • Hunan Cancer Hospital

    Changsha, Hunan, 410013

  • West China Hospital, Sichuan University

    Chengdu, Sichuan, 610041

  • Sichuan Academy of Medical Sciences and Sichuan Provincial Peoples Hospital

    Chengdu, Sichuan, 610071

  • Fujian Medical University Union Hospital

    Fuzhou, Fujian, 350001

  • Sun Yat Sen Memorial Hospital, Sun Yat Sen University (North)

    Guangzhou, Guangdong, 510000

  • Sun Yat Sen University Cancer Center

    Guangzhou, Guangdong, 510060

  • Zhejiang University College of Medicine Second Affiliated Hospital

    Hangzhou, Zhejiang, 310009

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang, 310022

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang, 150000

  • Jiangsu Province Cancer Hospital

    Nanjing, Jiangsu, 210008

  • Jiangsu Province Hospital

    Nanjing, Jiangsu, 210029

  • Fudan University Shanghai Cancer Center

    Shanghai, Shanghai Municipality, 200000

  • Liaoning Cancer Hospital and Institute

    Shenyang, Liaoning, 110042

  • Tianjin Medical University Cancer Institute and Hospital

    Tianjin, Tianjin Municipality, 300060

  • Zhongnan Hospital of Wuhan University Wuhan

    Wuhan, Hubei, 430071

  • Henan Cancer Hospital

    Zhengzhou, Henan, 450000

Other trials in China

About this study

Official title: An Open Label, Multi-Center Phase 2 Study to Evaluate Efficacy and Safety of BGB-290 in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China

This is a Phase 2, open-label, multi-center study of BGB-290 administered orally (PO) twice daily (BID) in adult Chinese patients with advanced HER2(-) breast cancer harboring germline BRCA mutation, which have progressed despite standard therapy, or for which no standard therapy exists.

Being tested
BGB-290

What participants receive

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

  • BGB-290Drug

    Also called Pamiparib

    Administered orally

Study groups in NCT03575065
Study groupRoleWhat they receive
Cohort 1: Triple-negative breast cancer (TNBC)ExperimentalLocally advanced or metastatic TNBC
Receives: Drug: BGB-290
Cohort 2: HR(+)/HER2(-) breast cancerExperimentalLocally advanced or metastatic Hormone receptor-positive(HR+) human epidermal growth factor receptor2 Negative(HER2-) breast cancer
Receives: Drug: BGB-290

What is being measured

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

  1. Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC)

    ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by IRC per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 months)

Secondary outcomes (9)

  1. ORR as Assessed by Investigator

    ORR is defined as the percentage of participants who achieved a best overall response of confirmed complete response (CR) or partial response (PR), assessed by the investigator per Response Evaluation Criteria in Solid Tumors (RECIST v1.1)

    Measured: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

  2. Progression-free Survival (PFS) as Assessed by IRC and Investigator

    PFS is defined as the time from first dose of pamiparib to the first documented disease progression or death due to any cause, assessed by IRC or the investigator

    Measured: From the first dose of pamiparib to first documentation of disease progression or death (Approximately 2 years and 10 months)

  3. Duration of Response (DOR) as Assessed by IRC

    DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by IRC

    Measured: From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

  4. Duration of Response (DOR) as Assessed by the Investigator

    DOR is defined as the time from first determination of a confirmed best overall response until the first documentation of progression or death, whichever comes first, assessed by the investigator

    Measured: From first documentation of confirmed CR or PR to first documentation of disease progression or death (Approximately 2 years and 10 months)

  5. Confirmed Best Overall Response (BOR) as Assessed by IRC and Investigator

    BOR is defined as the percentage of participants with best overall response recorded from the start of the treatment until disease progression or recurrence, assessed by IRC or the investigator. BOR included complete response [CR], partial response [PR], stable disease [SD], disease progression and not evaluable [NE].

    Measured: Approximately 2 years and 10 months

  6. Disease Control Rate (DCR) as Assessed by IRC and Investigator

    DCR is defined as the percentage of participants who achieved a confirmed BOR of CR, PR, or stable disease (SD), assessed by IRC or the investigator

    Measured: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months).

  7. Clinical Benefit Rate (CBR) as Assessed by IRC and Investigator

    CBR is defined as percentage of participants with confirmed CR or confirmed PR or a durable SD (SD lasting ≥ 24 weeks), assessed by IRC or the investigator

    Measured: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 10 months)

  8. Overall Survival (OS)

    OS is defined as time from the first dose of pamiparib to the date of death due to any cause

    Measured: From the first dose of pamiparib until death (approximately 2 years and 10 months)

  9. Number of Participants With Treatment-Emergent Adverse Events (TEAE) and Serious Adverse Events (SAE)

    A TEAE is defined as an adverse event (AE) that had an onset date on or after the first dose of study drug up to 30 days following study drug discontinuation. SAE is defined as any AE that leads to death or is life-threatening.

    Measured: Up to approximately 2 years and 10 months

Timeline

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

  1. First posted2 Jul 2018
  2. Study start22 Jun 2018
  3. Primary completion9 Oct 2020
  4. Study completion14 Apr 2021

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
Non-randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
88 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03575065
Sponsor's protocol ID
BGB-290-201
Other IDs
CTR20171623
Status last verified
Oct 2024
First submitted
19 Jun 2018
Last updated
26 Oct 2024
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Xu B, Zhang QY, Yang H, Gu T, Zhang K, Liang J, Qiu JJ, Yang R, Zhang L, Mu S, Sun J, Huang V, Dong M. An Open-Label, Multicenter, Phase 2 Study to Evaluate the Antitumor Activity and Safety of Pamiparib in the Treatment of Metastatic HER2-Negative Breast Cancer Patients With BRCA Mutation in China. Chinese Society of Clinical Oncology. 2018.

  • Xu B, Sun T, Shi Y, Cui J, Yin Y, Ouyang Q, Liu Q, Zhang Q, Chen Y, Wang S, Wang X, Tong Z, Zhong Y, Wang J, Yan M, Yan X, Wang C, Feng J, Wang X, Hu G, Cheng Y, Ge R, Zhu Z, Zhang W, Shao Z. Pamiparib in patients with locally advanced or metastatic HER2-negative breast cancer with germline BRCA mutations: a phase II study. Breast Cancer Res Treat. 2023 Feb;197(3):489-501. doi: 10.1007/s10549-022-06785-z. Epub 2022 Dec 2.

    PubMed 36459284

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing BGB-290 in people with HER2-negative Breast Cancer, run by BeiGene at 20 sites 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 11 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 26 Oct 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 20 sites 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?

Yes. Results are posted in the registry (first posted 7 Sep 2022). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

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?

Objective Response Rate (ORR) as Assessed by Independent Radiology Review (IRC) (time frame: From the first dose of pamiparib to first documentation of disease progression while participant is alive (Approximately 2 years and 4 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 NCT03575065, 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 26 Oct 2024.

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