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Breast NeoplasmsPhase 2/3NCT03500380

A Study of RC48-ADC Administered Intravenously to Patients With HER2-Positive Metastatic Breast Cancer With or Without Liver Metastases

A Phase 2/3 study testing RC48-ADC, Lapatinib and Capecitabine in people with Breast Neoplasms and Breast Diseases, run by RemeGen Co., Ltd. at 67 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 The sponsor has not verified this record for over two years, so it may be out of date.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

This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced… Read more about this study

Who is it for?
Ages 18 to 70 years
Conditions the study is for
Breast Neoplasms, Breast Diseases, Capecitabine
What is being tested?
RC48-ADC, Lapatinib and Capecitabine
Could I receive a placebo?
No, everyone receives an active treatment
How many people
301 participants
Where
67 sitesChina
Study dates
24 Apr 2018to 31 Dec 2024
Phase
Phase 2/3
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 70 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • Had previously participated in the study of randomized controlled period and received lapatinib plus capecitabine, and received no anti-tumor treatment after disease progression (RECIST v1.1 criteria);
  • The general situation part refers to the selection criteria of the first stage randomized control period.
  • Had previously participated in the study of randomized controlled period and received lapatinib plus capecitabine, and received no anti-tumor treatment after disease progression (RECIST v1.1 criteria);
  • Expected survival ≥ 12 weeks;
  • ECOG PS score 0 or 1;
  • Female subjects should be surgically sterilized or in post-menopausal status, or agree to use at least one medically accepted contraceptive methods (such as intrauterine device, contraceptive drug or condom) during study treatment period and for up to 6 months after the study treatment is completed, and the blood pregnancy test must be negative within 7 days prior to study enrollment, and they must not be lactating. For male subjects: all the subjects should be surgically sterilized or agree to use one of the medically approved contraceptive methods during the study treatment period and for an additional of 6 months after the end of the study treatment period.
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  • Able to understand study requirements, willing and able to comply with study protocol and follow-up procedures.
  • With Adequate Organ Function
  • Bone marrow function:
  • Hemoglobin ≥ 9 g/dL; Absolute neutrophil count ≥ 1.5×109/L; Platelets ≥ 100 × 109/L;
  • Liver function (based on the normal values specified by study site):
  • Serum total bilirubin ≤ 1.5 × the upper limit of normal (ULN); Alanine aminotransferase (ALT), aspartate aminotransferase (AST) and alkaline phosphatase (ALP) ≤ 2.5 × ULN in the absence of liver metastases, while ALT, AST and ALP ≤ 5 × ULN in the presence of liver metastases;
  • Renal function (based on the normal values specified by study site):
  • Serum creatinine ≤ 1.5 × ULN, or creatinine clearance (CrCl) ≥ 60 mL/min as calculated by Cockcroft-Gault formula, or 24-hour urine Crcl ≥ 60 mL/min;
  • Cardiac function:
  • New York Heart Association (NYHA) classification < Grade III; Left ventricular ejection fraction ≥ 50%;

Who cannot join

  • Have received major surgeries within 4 weeks prior to study treatment and have not recovered yet;
  • Have received a live vaccine inoculation within 4 weeks prior to the start of study drug administration or was scheduled to receive any vaccine during the study (except the COVID-19 vaccine);
  • Have experienced arterial/venous thromboembolic events, such as cerebrovascular accident (including transient ischemic attack), deep vein thrombosis and pulmonary embolism within 1 year prior to the initiation of study treatment;
  • Suffering uncontrolled systemic diseases, including diabetes, hypertension, pulmonary fibrosis, acute lung disease, interstitial lung disease, cirrhosis, etc.;
  • Currently suffering from active infections requiring systemic treatment;
  • With positive HIV test result;
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  • Patients with active hepatitis B or C (HBsAg positive and HBV DNA positive; HCVAb positive);
  • Presence of effusiona in the third space (including massive hydrothorax or ascites) that cannot be controlled by drainage or other means;
  • With known hypersensitivity or delayed-type hypersensitivity to certain components of RC48-ADC or similar drugs;
  • With known psychiatric disorders or drug abuse disorders that might have an impact on compliance with protocol requirements;
  • Have any other diseases, metabolic disorders, abnormal physical examination findings or abnormal laboratory test results, which, judged by the investigator, are reasonably to suspect a disease or condition as a contraindication of the study drug, or may interfere the interpretation of the study results in the future, or that put the patient at a high risk;
  • Women who are pregnant or in lactation period or women/men with childbearing plans;
  • Subjects who are estimated to have poor compliance with the protocol of this cross-over period or the investigator determines that there are other factors not appropriate to participate in the study;
  • Presence of brain metastases and/or carcinomatous meningitis. Have received prior treatment for brain metastases may be considered for participating in this study, provided that the diseases were stable, had no disease progression as confirmed by imaging examinations within 4 weeks prior to the first dose of the investigational product (IP), and that all neurological symptoms have recovered to baseline level without any evidence of newly emerging or spread brain metastases; moreover, treatment with radiation, surgery or steroids was discontinued at least 14 days prior to the first dose of study drug. This exception did not include cancerous meningitis, which should be excluded regardless of the stability of its clinical status;
  • Patients who received palliative radiotherapy for bone metastases within 2 weeks before the start of study treatment;
  • Received treatment with lapatinib and/or capecitabine within 2 weeks prior to the first dose of the study drug;
  • The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 4.03] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator;
  • Inclusion Criteria for Randomized Controlled Period in Stage II：
  • The general situation part refers to the selection criteria of the first stage randomized control period.
  • Exclusion Criteria for Randomized Controlled Period in Stage II：
  • The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 5.0] Grade 0-1, with the following exceptions: a). alopecia; b). pigmentation; c). long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator;
  • The remaining parts refer to the exclusion criteria of the first stage randomized control period.
  • The toxicity of prior anti-tumor therapy had not recovered to CTCAE [Version 5.0] Grade 0-1, with the following exceptions: a. alopecia; b. pigmentation; c. long-term toxicity caused by radiotherapy, which are considered as irreversible by the investigator;
  • The remaining parts refer to the exclusion criteria of the first phase of the crossover period.

Trial locations and contacts

67 sites in 1 country.

67 sites in 1 country

China67 sites

  • An Yang Cancer Hospital

    Anyang

  • Cancer Hospital Chinese Academy of Medical Sciences

    Beijing, Beijing Municipality, 100021

  • Beijing Luhe Hospital

    Beijing

  • Peking University People's Hospital

    Beijing

  • The First Affiliated Hospital of Bengbu Medical College

    Bengbu

  • Bin Zhou No.1 People's Hospital

    Binzhou

  • Jilin Cancer Hospital

    Changchun

  • The First Hospital Jilin University

    Changchun

  • The First Hospital of Jilin University

    Changchun

  • Hunan Cancer Hospital

    Changsha

  • The Second Xiyang Hospital of Central South University

    Changsha

  • Xiangya Hospital Central South University

    Changsha

  • Heping Hospital Affiliated to Changzhi Medical College

    Changzhi

  • Affiliated Hospital of Chengde Medical University

    Chengde

  • West China Hospital,Sichuan University

    Chengdu

  • Chongqing University Three gorges Hospital

    Chongqing

  • The Southwest Hospital of AMU

    Chongqing

  • The Second Hospital of Dalian Medical University

    Dalian

  • Fujian Cancer Hospital

    Fuzhou

  • Guangdong Provincial People's Hospital

    Guangzhou

  • Sun Yat-Sen Memorial Hospital

    Guangzhou

  • The Affiliated Tumor Hospital of Guangzhou Medical University

    Guangzhou

  • Guizhou Cancer Hospital

    Guiyang

  • Harbin Medical University Cancer Hospital

    Ha’erbin

  • The First Affiliated Hospital of Medical School of Zhejiang University

    Hangzhou

  • The Second Affiliated Hospital of Zhejiang University School of Medicine

    Hangzhou

  • Zhejiang Cancer Hospital

    Hangzhou

  • Anhui Cancer Hospital

    Hefei

  • Anhui Province Hospital

    Hefei

  • The First Affiliated Hospital of Anhui Medical University

    Hefei

  • Qilu Hospital of Shandong University

    Jinan

  • The First People's Hospital of Jining

    Jining

  • Yunnan Cancer Hospital

    Kunming

  • Linyi Cancer Hospital

    Linyi

  • The First Affiliated Hospital of Henan University of Science & Technology

    Luoyang

  • Jiangsu Cancer Hospital

    Nanjing

  • The Affiliated Tumor Hospital of Guangxi Medical University

    Nanning

  • The Second People's Hospital of Neijiang

    Neijiang

  • Hospital of Qingdao University

    Qingdao

  • Fudan University Shanghai Cancer Center

    Shanghai

  • Shanghai Changhai Hospital

    Shanghai

  • Shanghai Ruijin Hospital

    Shanghai

  • Cancer Hospital of Shantou University Medical College

    Shantou

  • Yue Bei People's Hospital

    Shaoguan

  • Liaoning Cancer Hospital & Institute

    Shenyang, Liaoning

  • The First Hospital of China Medical University

    Shenyang, Liaoning

  • The Fourth Hospital of Hebei Medical University

    Shijiazhuang

  • Tai'an City Central Hospital

    Tai’an

  • Shanxi Bethune Hospital

    Taiyuan

  • Shanxi Cancer Hospital

    Taiyuan

  • Taizhou Enze Medical Center

    Taizhou

  • Tianjin Cancer Hospitial

    Tianjin

  • Weihai Municipal Hospital

    Weihai

  • Hubei Cancer Hospital

    Wuhan

  • Tongji Medical College of HUST

    Wuhan

  • Wuhan Union Hospital

    Wuhan

  • The First Affiliated Hospital of the Fourth Military University of P.L.A.

    Xi'an

  • The First Affiliated Hospital of Xi'an Jiaotong University

    Xi'an

  • Xing Tai People's Hospital

    Xingtai

  • The First Affiliated Hospital of Xinxiang Medical University

    Xinxiang

  • The Affiliated Hospital of Xuzhou Medical University

    Xuzhou

  • Xuzhou Central Hospital

    Xuzhou

  • Yanbian University Hospital

    Yanbian

  • Yantai Yuhuangding Hospital

    Yantai

  • Yuncheng Central Hospital

    Yuncheng

  • Henan Cancer Hospital

    Zhengzhou

  • The First Affiliated Hospital of Zhengzhou University

    Zhengzhou

Other trials in China

About this study

Official title: A Randomized, Controlled, Multi-center Phase II Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Locally Advanced or Metastatic Breast Cancer and Phase III Clinical Study to Evaluate the Efficacy and Safety of Recombinant Humanized Anti-HER2 Monoclonal Antibody-MMAE Conjugate for Injection in the Treatment of HER2-positive Advanced Breast With Liver Metastases

This is a randomized, open, parallel-controlled, multicenter, phase II/III, seamless design clinical trial to compare the efficacy and safety of RC48-ADC with capecitabine + lapatinib in locally advanced or metastatic human epidermal growth factor receptor 2 (HER2) positive breast cancer and HER2-positive advanced breast cancer with liver metastasis.

Being tested
RC48-ADC, Lapatinib, Capecitabine
Medical subject headings
Breast Neoplasms, Breast Diseases

What participants receive

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

  • RC48-ADCDrug

    Also called RC48

    RC48-ADC 2.0 mg/kg IV every 14 days

  • LapatinibDrug

    Lapatinib 1250 mg orally once daily during each 21-day cycle.

  • CapecitabineDrug

    Capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle.

Study groups in NCT03500380
Study groupRoleWhat they receive
RC48-ADCExperimentalParticipants will receive RC48-ADC 2.0 mg/kg intravenous (IV) infusion each 14-day treatment cycle until disease progression (PD) (as assessed by the investigator), unmanageable toxicity, or study termination.
Receives: Drug: RC48-ADC
Lapatinib + CapecitabineActive comparatorParticipants will receive lapatinib 1250 mg orally once daily during each 21-day cycle + capecitabine 2000 mg/m^2 orally daily on Days 1-14 of each 21-day treatment cycle until PD (as assessed by the investigator), unmanageable toxicity, or study termination.
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) as Assessed by an IRC

    Tumor response was assessed by an IRC according to RECIST v1.1.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

Secondary outcomes (6)

  1. Progression-free Survival (PFS) as Assessed by Investigator

    Tumor response was assessed by investigator according to RECIST v1.1.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  2. Objective Response Rate （ORR）

    Objective Response Rate was defined as the percentage of participants with a complete response (CR) or partial response (PR).

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  3. Duration of Objective Response (DOR)

    DOR was defined as the time from first documented OR to first documented PD or death from any cause, whichever occurred earlier.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  4. Clinical Benefit Rate （CBR）

    Participants were considered as experienced clinical benefit if they had an OR or maintained stable disease (SD) for at least 6 months from randomization. OR: CR or PR determined on 2 consecutive tumor assessments >/=4 weeks apart.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  5. Time to Treatment Failure

    Time to treatment failure was defined as the time from randomization to discontinuation of treatment for any reason, including PD (per investigator review), treatment toxicity, or death from any cause.

    Measured: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 24 months

  6. Overall Survival

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

    Measured: From date of randomization until the date of death from any cause, assessed up to 48 months

Timeline

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

  1. First posted18 Apr 2018
  2. Study start24 Apr 2018
  3. Primary completion31 Jul 2024 (estimated)
  4. Study completion31 Dec 2024 (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 2/3
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Crossover
Masking
None (open label)
Enrolment
301 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03500380
Sponsor's protocol ID
RC48-C006
Status last verified
Nov 2023
First submitted
8 Apr 2018
Last updated
20 Feb 2024
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No

Publications

  • Wang J, Ouyang Q, Xie W, Niu Z, Zhang Q, Yan X, Teng Y, Chang J, Cheng Y, Wang A, Wang J, Yao H, Yang Z, Sun T, Tong Z, Wu X, Wang Y, Zhou E, Kong X, Wang X, Zeng D, Gu S, Hou Y, Gao D, Qu Z, Han C, Fang J, Xu B. Disitamab vedotin for HER2-positive breast cancer with liver metastases: phase 3 results from the RC48-C006 phase 2/3 trial. Nat Commun. 2026 Aug 27;17(1):10236. doi: 10.1038/s41467-026-75733-y.

    PubMed 42802176

Questions about this trial

What is this clinical trial studying?

A Phase 2/3 study testing RC48-ADC, Lapatinib and Capecitabine in people with Breast Neoplasms and Breast Diseases, run by RemeGen Co., Ltd. at 67 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 16 inclusion and 24 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 20 Feb 2024. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 67 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 combined 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.

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) as Assessed by an IRC (time frame: From date of randomization until the date of first documented progression or date of death from any cause, whichever came first, assessed up to 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 NCT03500380, which also lists 1 linked publication.

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 20 Feb 2024.

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