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HER2-positive Advanced Breast CancerPhase 3NCT04185649

The Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer

A Phase 3 study testing BAT8001 for injection, Lapatinib and Capecitabine in people with HER2-positive Advanced Breast Cancer, run by Bio-Thera Solutions at 51 sites 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 The sponsor has not verified this record for over two years, so it may be out of date.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

To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug. Read more about this study

Who is it for?
Ages 18 to 75 years
Conditions the study is for
HER2-positive Advanced Breast Cancer
What is being tested?
BAT8001 for injection, Lapatinib and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
410 participants
Where
51 sitesChina
Study dates
1 Jul 2018to 31 Dec 2021
Phase
Phase 3
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
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Patients are required to provide at least 10 unstained sections.
  • HER2-positive (defined as: IHC 3+ or FISH+) confirmed by the central laboratory of this study.
  • Histologically and/or cytologically confirmed invasive breast cancer, including unresectable locally advanced breast cancer (LABC) or metastatic breast cancer (MBC).
  • LABC or MBC that has progressed during or after treatment, or during or within 12 month following adjuvant therapy as confirmed by imaging.
  • Previously received adjuvant therapy, or locally advanced/metastatic breast cancer treatment regimen that included taxanes and trastuzumab (including approved biosimilars) as monotherapy or combination therapy。
  • At least one measurable lesion or a single metastatic tumor in the bone as per the Response Evaluation Criteria in Solid Tumor (RECIST) 1.1.
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  • A score of 0-1 for performance status as per the Eastern Cooperative Oncology Group (ECOG) scale.
  • Expected survival ≥ 3 months.
  • Left ventricular ejection fraction (LVEF) ≥ 50%.
  • If anthracyclines are used, the cumulative dose must meet the following criteria: the cumulative dose must not exceed the equivalent dose of doxorubicin 500 mg/m2.
  • Women of childbearing age or fertile male subjects must agree to use oral, implanted, or injectable hormone contraceptives as well as one or two forms of non-hormonal contraceptive measures during the study period and until 6 months after the end of the study.
  • Blood pregnancy test must indicate non-pregnant for all women of childbearing potential and those who do not meet the definition of postmenopause.

Who cannot join

  • Current presence of grade ≥ 2 peripheral neuropathy.
  • History of other malignant tumors within the past 5 years, but does not include properly treated cervical carcinoma in situ, non-melanoma skin cancer, stage 1 uterine cancer, or other tumors with good prognosis.
  • Received treatment with a cancer drug or investigational drug within 21 days from the first dose of the study drug, except for hormone therapy..
  • Received radiation therapy within 14 days prior to the first test drug administration of this study; or subject has not recovered from the acute toxicity of radiation therapy prior to the first test drug administration of this study.
  • Brain metastasis that is symptomatic or requires treatment to control symptoms within 30 days before randomization.
  • Subjects who must receive the first test drug administration within less than 14 days following the completion of radiation therapy for symptomatic brain metastasis.
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  • Currently experiences moderate or severe dyspnea at rest caused by advanced malignancy or other complications or severe primary lung diseases, or currently requires continuous oxygen therapy, or subject currently suffers from interstitial lung disease (ILD) or pneumonia/pneumonitis.
  • History of myocardial infarction or unstable angina within 6 months prior to first test drug administration.
  • Previous history of LVEF falling below 40%; or presence of symptomatic congestive heart failure (CHF) during trastuzumab (including other analogues) treatment.
  • Symptomatic congestive heart failure (CHF; New York Heart Association [NYHA] Class II-IV); Severe arrhythmias requiring treatment.
  • Presence of severe and uncontrollable systemic diseases (e.g. clinically significant cardiovascular, lung or metabolic diseases).
  • Patients who currently require coumarin derivative-based anticoagulation therapy such as warfarin and phenprocoumon.
  • Presence of diseases that may affect intestinal absorption, including malabsorption syndrome, stomach and small bowel resection, and ulcerative colitis.
  • Intolerance (grade 3-4 infusion reactions) or allergy to trastuzumab (and other analogues) or mouse proteins or any ingredient of the medication.

Trial locations and contacts

51 sites in 1 country.

51 sites in 1 country

China51 sites

  • Beijing Hospital

    Beijing, Beijing Municipality

  • Beijing Shijitan Hospital

    Beijing, Beijing Municipality

  • Chinese PLA General Hospital

    Beijing, Beijing Municipality

  • Peking union medical college hospital

    Beijing, Beijing Municipality

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu, Anhui

  • Jilin Cancer Hospital

    Changchun, Jilin

  • The First Bethune Hospital of Jilin University

    Changchun, Jilin

  • Hunan Cancer Hospital

    Changsha, Hunan

  • Xiangya Hospital Central South University

    Changsha, Hunan

  • West China Hospital of Sichuan University

    Chengdu, Sichuan

  • Chongqing Cancer Hospital

    Chongqing, Chongqing Municipality

  • Foshan City No. 1 People's Hospital

    Foshan, Guangdong

  • Cancer Center of Guangzhou Medical University

    Guangzhou, Guangdong

  • Sun Yat-sen Memorial Hospital. SYSU

    Guangzhou, Guangdong

  • Sun Yat-sen University Cancer Center

    Guangzhou, Guangdong

  • The First Affiliated Hospital of Hainan Medical College

    Haikou, Hainan

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou, Zhejiang

  • Zhejiang Cancer Hospital

    Hangzhou, Zhejiang

  • Harbin Medical University Cancer Hospital

    Harbin, Heilongjiang

  • Anhui Provincial Hospital

    Hefei, Anhui

  • Shandong Cancer Hospital

    Jinan, Shandong

  • Jinzhou Central Hospital

    Jinzhou, Liaoning

  • Yunnan Cancer Hospital

    Kunming, Yunnan

  • Linyi Cancer Hospital

    Linyi, Shandong

  • Liuzhou workers hospital

    Liuzhou, Guangxi

  • The First Affiliated Hospital of Henan University of science and technology

    Luoyang, Henan

  • Jiangxi Cancer Hospital

    Nanchang, Jiangxi

  • The Third Hospital of Nanchang

    Nanchang, Jiangxi

  • Jiangsu Cancer Hospital

    Nanning, Jiangsu

  • Fudan University Shanghai Cancer Hospital

    Shanghai, Shanghai Municipality

  • Shanghai General Hospital

    Shanghai, Shanghai Municipality

  • Shanghai Sixth People's Hospital

    Shanghai, Shanghai Municipality

  • The Second Hospital of Anhui Medical University

    Shanghai, Shanghai Municipality

  • Liaoning Cancer Hospital

    Shenyang, Liaoning

  • Peking University Shenzhen Hospital

    Shenzhen, Guangdong

  • Shenzhen People's Hospital

    Shenzhen, Guangdong

  • Taizhou Hispotal of Zhejiang Province

    Taizhou, Zhejiang

  • Weifang People's Hospital

    Weifang, Shandong

  • Hubei Cancer Hospital

    Wuhan, Hubei

  • Tongji Hospital of Tongji Medical College of HUST

    Wuhan, Hubei

  • Zhongnan Hospital of Wuhan University

    Wuhan, Hubei

  • Affiliated Hospital of Jiangnan University

    Wuxi, Jiangsu

  • Shanxi Cancer Hospital

    Xi’an, Shanxi

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi’an, Shanxi

  • The First Affiliated Hospital of Xiamen University

    Xiamen, Fujian

  • The First Affiliated Hospital of Xixiang Medical College

    Xinxiang, Henan

  • Yancheng City No. 1 People's Hospital

    Yancheng, Jiangsu

  • Yichang Central Hospital

    Yichang, Hubei

  • General Hospital of Ningxia Medical University

    Yinchuan, Ningxia

  • The First Affiliated Hospital of Guangdong Medical University

    Zhanjiang, Guangdong

  • The Fifth Affiliated Hospital Sun Yat-sen University

    Zhuhai, Guangdong

Other trials in China

About this study

Official title: A Clinical Study Evaluating the Efficacy and Safety of BAT8001 Injection for the Treatment of HER2-positive Advanced Breast Cancer - A Multicenter, Randomized, Open-label, Positive-controlled, Superiority Phase III Clinical Trial in China

To evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.

Read the detailed description

This is a multicenter, randomized, open-label, positive-controlled, superiority phase III clinical study. The object is to evaluate the safety and efficacy of BAT8001 for the treatment of HER2-positive advanced breast cancer, using lapatinib in combination with capecitabine as the positive control drug.

Eligible subjects will be randomized to the experimental or control group in a 1:1 ratio and stratified by the number of HER2-positive advanced/metastatic breast cancer treatment regimens (0, 1 VS > 1) and lesion site (organ VS non-organ).

Being tested
BAT8001 for injection, Lapatinib, Capecitabine

What participants receive

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

  • BAT8001 for injectionBiological

    3.6 mg/kg, q3w, administered intravenously on day 1 of each treatment cycle, 21 days/treatment cycle.

  • LapatinibDrug

    Also called Lapatinib ditosylate tablets

    Lapatinib 1250 mg was administered orally once per day of each 21-day cycle.

  • CapecitabineDrug

    Also called capecitabine tablets

    Capecitabine 1000 milligrams per square meter (mg/m^2) was administered orally twice daily on Days 1-14 of each 21-day cycle.

Study groups in NCT04185649
Study groupRoleWhat they receive
BAT8001 for injectionExperimentalParticipants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with trastuzumab emtansine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
Receives: Biological: BAT8001 for injection
Control (lapatinib + capecitabine)Active comparatorParticipants with HER2-positive, unresectable LABC or MBC who have experienced disease progression after treatment with trastuzumab and a taxane will be treated with lapatinib plus capecitabine. Participants may continue to receive study treatment until disease progression (as assessed by the investigator), unmanageable toxicity, or study termination by the Sponsor.
Receives: Drug: Lapatinib; Drug: Capecitabine

What is being measured

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

  1. Progression-free survival (PFS)

    PFS is defined as the time from randomization to the first occurrence of disease progression as determined by the investigator using Response Evaluation Criteria in Solid Tumors (RECIST) Version (v1.1), or death from any cause during the study, whichever occurs first.

    Measured: Up to approximately 18 months

Secondary outcomes (8)

  1. Overall Survival (OS)

    OS is defined as the time from the date of randomization to the date of death from any cause.

    Measured: Up to approximately 30 months

  2. Objective Response Rate (ORR)

    ORR is defined as percentage of participants with partial response (PR) or complete response (CR) determined on the basis of investigator assessments with the use of RECIST v1.1.

    Measured: Up to approximately 30 months

  3. Duration of Response (DOR)

    DOR is defined as as the time from the date of initial confirmed PR or CR to the date of disease progression or death within the study.

    Measured: Up to approximately 30 months

  4. Clinical Benefit Rate (CBR)

    CBR is defined as the proportion of subjects with best overall response (confirmed PR or CR) or with stable disease (confirmed SD) for at least 6 months;

    Measured: Up to approximately 30 months

  5. Serum Concentration of BAT8001

    Concentration of BAT8001 will be measured in serum from participants, who received BAT8001.

    Measured: Pre-dose and 15-30 minutes after dose on Day 1, Day 8, Day 15 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)

  6. Serum Concentration of total antibody of BAT8001 for injection

    Concentration of total antibody will be measured in serum from participants, who received BAT8001.

    Measured: Pre-dose and 15-30 minutes after dose on Day 1, Day 8, Day 15 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)

  7. Plasma Concentration of batansine (a maytansine derivative, which is the 3AA-MDC complex)

    Concentration of batansine will be measured in plasma from participants, who received BAT8001.

    Measured: Pre-dose and 15-30 minutes after dose on Day 1, Day 8, Day 15 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)

  8. Percentage of Participants with Anti-therapeutic Antibodies (ATA) to BAT8001

    ATA to BAT8001 were measured in serum of participants, who received BAT8001.

    Measured: Pre-dose on Day 1 of each 21-day cycle during Cycles 1-4 and at completion/early termination visit (up to approximately 30 months)

Timeline

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

  1. First posted4 Dec 2019
  2. Study start1 Jul 2018
  3. Primary completion31 Jul 2020 (estimated)
  4. Study completion31 Dec 2021 (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
410 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT04185649
Sponsor's protocol ID
BAT-8001-002-CR
Status last verified
Dec 2019
First submitted
1 Dec 2019
Last updated
4 Dec 2019
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 3 study testing BAT8001 for injection, Lapatinib and Capecitabine in people with HER2-positive Advanced Breast Cancer, run by Bio-Thera Solutions at 51 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 12 inclusion and 14 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 4 Dec 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 51 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 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?

Results are not available in the source record.

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?

Progression-free survival (PFS) (time frame: Up to approximately 18 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 NCT04185649.

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 4 Dec 2019.

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