Breast CancerPhase 3NCT04400695

A Study of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

A Phase 3 study testing RC48-ADC, Paclitaxel Injection and Docetaxel Injection in people with Breast Cancer, run by RemeGen Co., Ltd. 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

Search all trials

Trial summary

This study will compare RC48-ADC to physician choice standard treatment. Participants must have HER2-low breast cancer ，previous use of anthracyclines, and have been treated with one or two systemic chemotherapy regimens following recurrence/metastasis. Read more about this study

Who is it for?: Ages 18 to 70 years
Conditions the study is for: Breast Cancer
What is being tested?: RC48-ADC, Paclitaxel Injection and Docetaxel Injection
Type of treatment: Pill or oral medicine, Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 366 participants
Where: 1 siteChina
Study dates: 29 Sep 2020to 31 Dec 2027
Phase: Phase 3
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 to 70 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Voluntarily agree to participate in the study and sign the informed consent;
Subjects aged 18-70 years (including 18 years and 70 years) and not reaching the 71st birthday were all considered to be ≤70 years old;
Expected survival ≥12 weeks;
Eastern Cooperative Oncology Group(ECOG) physical condition 0 or 1;
For female subjects of child-bearing age women agreed to study during treatment and experimental subjects within 6 months after the end of the treatment period using an approved by the medical contraception (e.g. intrauterine device, the pill or condoms), before the study drug delivery within 7 days of pregnancy blood test must be negative (sterilization surgery or age 60 or more subjects can choose no pregnancy blood test), and must be an lactation. For male subjects: should be sterilized surgically, or agree to use a medically approved contraceptive method during the study period and for 6 months after the end of the treatment period. Control subjects after the end of the treatment period according to the choice of control drugs to determine the length of contraception.
Able to understand the study requirements and be willing and able to follow the study and follow-up procedures.

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Bone marrow function:
hemoglobin ≥9g/dL; absolute neutrophil count ≥1.5×109/L; white blood cell count ≥3.0×109/L platelet ≥100 ×109/L;
Liver function (according to the normal value of the clinical trial center) :
serum total bilirubin ≤1.5 times the upper limit of normal value (ULN); alanine aminotransferase (ALT), aspartate aminotransferase(AST) and Alkaline phosphatase（ALP） were ≤2.5 × ULN in the absence of liver metastasis, and ALT, AST and Alkaline phosphatase(ALP) were ≤5 × ULN in the presence of liver metastasis
Renal function (according to the normal value of the clinical trial center) :
serum creatinine ≤1.5×ULN, or calculated by Cockcroft-Gault formula, the creatinine clearance rate (CrCl) ≥60 mL/min;
Cardiac function:
American New York college of cardiology (NYHA) grade < 3; left ventricular ejection fraction ≥50%;
Breast cancer subjects diagnosed by histology and / or cytology are currently at a locally advanced or metastatic stage and cannot be radically removed;
The low expression of HER2 confirmed by the IHC and FISH results of the central laboratory (defined as: IHC 2+ and no amplification of FISH); the subject can provide a specimen of the primary or metastatic tumor site (paraffin wax) for HER2 detection Block, paraffin-embedded section or fresh tissue section can be used);
Previous use of anthracycline drugs;
Received 1 or 2 systemic chemotherapy treatments after relapse / metastasis. Subjects who relapsed during adjuvant chemotherapy or within 12 months after the end of adjuvant chemotherapy were considered to have failed first-line chemotherapy after relapse / metastasis.
Hormone receptors are negative or positive. Hormone receptor-positive subjects need to progress after receiving endocrine therapy after relapse / metastasis or relapse after less than 2 years. Patients who are not suitable for endocrine therapy can be included in this study after undergoing chemotherapy treatment (first-line or second-line);
The imaging evidence confirmed by the investigator that the tumor disease progressed during or after the most recent treatment is required;
There has been no diagnosis of HER2 positive (HER2 IHC 3+ or FISH amplification)
Have not used drugs targeting HER2 (including antibodies, small molecule Tyrosine kinase inhibitor（TKIs） and antibody drug conjugates).
According to the RECIST 1.1 standard, there is at least one measurable lesion.

Who cannot join

Received chemotherapy within 4 weeks before the start of study administration (treatment with nitrosourea and mitomycin C within 6 weeks, oral fluorouracil within 2 weeks), radiotherapy (palliative for bone metastases Local radiotherapy is within 2 weeks before study administration), immunotherapy; received endocrine therapy for breast cancer within 2 weeks before study administration;
The research drug was used within 4 weeks before the start of study administration;
Have undergone major surgery within 4 weeks before the start of study administration;
Have received a live vaccine within 4 weeks before the start of study administration or plan to receive any vaccine during the study period;
Serious cardiovascular and cerebrovascular events occurred within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except for asymptomatic and untreated lacunar infarction)；
Those who are suffering from heart disease are not suitable for enrollment, including but not limited to arrhythmia and heart failure requiring medical treatment or accompanied by symptoms;

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There are other lung diseases requiring treatment or serious, including but not limited to active pulmonary tuberculosis, interstitial lung disease, etc ;
Suffering from active infection requiring systemic treatment;
Have active autoimmune diseases (such as the use of corticosteroids or immunosuppressive drugs, etc.) that require systemic treatment within the past 2 years, allowing related alternative treatments (such as thyroxine, insulin, or the physiology of adrenal or pituitary insufficiency Corticosteroid replacement therapy);
The toxicity of the previous anti-tumor therapy has not been restored to the 0 to 1 level defined by CTCAE version 5.0, of which the neurotoxicity has not been restored to 0; except for hair loss, pigmentation or other researches that do not increase the risk of medication Happening;
Have a clear past or current history of neurological or mental disorders, including epilepsy or dementia;
According to the investigator's judgment, there are concomitant diseases that seriously endanger the safety of the subject or affect the completion of the clinical study；
Positive HIV test results; patients with active hepatitis B or C (HBsAg positive and hepatitis B virus（HBV） DNA titers above the upper limit of normal; Hepatitis C Virus Antibody(HCVAb) positive hepatitis C virus （HCV） RNA titers above the upper limit of normal)；
There is a third interstitial fluid that cannot be controlled by drainage or other methods (including a large amount of pleural effusion or ascites);
Known hypersensitivity or delayed allergic reaction to certain components of RC48-ADC or similar drugs;
Subjects who are not suitable for using any of the alternative control drugs;
The presence of brain metastases and / or cancerous meningitis;
Have other malignant tumors within 5 years before signing the informed consent form (except for non-melanoma skin cancer, cervical carcinoma in situ or other tumors that have been effectively treated, except malignant tumors that are considered cured);
Subjects who are estimated to be inadequate for patients to participate in this clinical study or other factors that the investigator believes are inappropriate to participate in this study;

Trial locations and contacts

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

Binghe Xu, M.D. contact

010-87788826

bhxu@hotmail.com

China1 site, 1 recruiting

Oncology Hospital, Chinese Academy of Medical Sciences
Beijing, Beijing Municipality, 100021
Binghe Xu, 010-87788826, bhxu@hotmail.com
Recruiting

Other trials in China

About this study

Official title: Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2

Read the detailed description

This study is a multi-center, randomized, open, parallel control to evaluate the effectiveness and safety of Phase III clinical trials of the efficacy and safety of recombinant humanized anti-HER2 monoclonal antibody-Monomethyl auristatin E (MMAE) conjugate for the treatment of locally advanced or metastatic breast cancer the study.The low expression of HER2 is defined as: the immunohistochemistry (IHC) confirmed by the central laboratory detects the expression of HER2 protein as IHC 2+ and the fluorescence in situ hybridization (FISH) detection has no amplification.

Conditions: Breast Cancer
Being tested: RC48-ADC, Paclitaxel Injection, Docetaxel Injection, Vinorelbine Tartrate Injection, Capecitabine Tablets
Medical subject headings: Breast Neoplasms

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 2.0mg / kg, intravenous drip, once every 2 weeks
Paclitaxel InjectionDrug
Also called Taxol
Administered according to label, as one option for Physician's Choice (determined before randomization)
Docetaxel InjectionDrug
Also called Taxotere
Administered according to label, as one option for Physician's Choice (determined before randomization)
Vinorelbine Tartrate InjectionDrug
Also called Navelbine
Administered according to label, as one option for Physician's Choice (determined before randomization)
Capecitabine TabletsDrug
Also called Xeloda
Administered according to label, as one option for Physician's Choice (determined before randomization)

Study groups in NCT04400695
Study group	Role	What they receive
RC48-ADC	Experimental	RC48-ADC common name：Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection Dosage form：Lyophilized powder injection specification：60 mg / piece Medication plan：Every 2 weeks Expiration date：18 months HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis. Receives: Drug: RC48-ADC
Physician's Choice	Active comparator	Physician's Choice: HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis. Physician's choice from the following options: Paclitaxel Injection Docetaxel Injection Vinorelbine Tartrate Injection Capecitabine Tablets Receives: Drug: Paclitaxel Injection; Drug: Docetaxel Injection; Drug: Vinorelbine Tartrate Injection; Drug: Capecitabine Tablets

What is being measured

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

Progression-free survival (PFS), evaluated by an independent efficacy evaluation committee
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Measured: within approximately 3 years

Secondary outcomes (6)

Progression-free survival (PFS), evaluated by the investigator
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.
Measured: within approximately 3 years
Objective remission rate (ORR)
The objective response rate will be mainly analyzed by the independent efficacy evaluation committee according to the RECIST 1.1 standard tumor evaluation (the evaluation by the investigator will also be performed).
Measured: within approximately 3 years
Duration of relief (DOR)
DOR is defined as the time from the first documented objective response (CR or PR) to the first documented disease progression or death
Measured: within approximately 3 years
Disease control rate (DCR)
Disease control rate (DCR) is defined as cases where objective remission (assessed as complete remission or partial remission according to RECIST 1.1 standard) or stable disease during the study.
Measured: within approximately 3 years
Tumor progression time (TTP)
Time to disease progression (TTP) refers to the time from the random date to the first disease progression (calculated by the event that occurred first). Disease progression will be evaluated by the investigator according to the RECIST 1.1 standard (investigator and Independent Review Committee(IRC) evaluation).
Measured: within approximately 3 years
Overall survival (OS)
Overall survival (OS) refers to the time from the date of randomization to the date of death of the subject.
Measured: within approximately 3 years

Timeline

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

29 Sep 202031 Dec 2027

First posted22 May 2020
Study start29 Sep 2020
Primary completion31 Dec 2027 (estimated)
Study completion31 Dec 2027 (estimated)

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Other trials for Breast CancerStudies of the same condition, open and under way.
More trials run by RemeGen Co., Ltd.The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

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: 366 participants (estimated)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04400695
Sponsor's protocol ID: RC48-C012
Status last verified: Sep 2026
First submitted: 30 Apr 2020
Last updated: 23 Sep 2026
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: No
Individual data sharing: No

Interested in taking part?

Binghe Xu, M.D.

010-87788826

bhxu@hotmail.com

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See sites and contacts

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All Breast Cancer trials

Study at a glance

From the registry record, last updated by the sponsor on 23 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized, Controlled, Multicenter Phase III Clinical Study Evaluating the Efficacy and Safety of RC48-ADC for the Treatment of Locally Advanced or Metastatic Breast Cancer With Low Expression of HER2
ClinicalTrials.gov ID: NCT04400695
Acronym / sponsor ID: RC48-C012
Conditions: Breast Cancer
Phase: Phase 3
Study type: Interventional
Recruitment status: Recruiting
Enrolment: 366 participants (estimated)
Lead sponsor: RemeGen Co., Ltd.Industry (pharma, biotech, devices)
Study start: 29 Sep 2020 (actual)
Primary completion: 31 Dec 2027 (estimated)
Study completion: 31 Dec 2027 (estimated)
First posted: 22 May 2020 (actual)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
RC48-ADC	Experimental	Drug: RC48-ADCRC48-ADC common name：Recombinant Humanized anti-HER2 Monoclonal Antibody-MMAE Conjugate For Injection Dosage form：Lyophilized powder injection specification：60 mg / piece Medication plan：Every 2 weeks Expiration date：18 months HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis.
Physician's Choice	Active comparator	Drug: Paclitaxel Injection, Drug: Docetaxel Injection, Drug: Vinorelbine Tartrate Injection, Drug: Capecitabine TabletsPhysician's Choice: HER2-low, unresectable, locally advanced or metastatic breast cancer participants previously treated with anthracycline and received 1 or 2 systemic chemotherapy after relapse / metastasis. Physician's choice from the following options: Paclitaxel Injection Docetaxel Injection Vinorelbine Tartrate Injection Capecitabine Tablets

Who may qualify

Ages: 18 to 70 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (23 listed)

Voluntarily agree to participate in the study and sign the informed consent;
Subjects aged 18-70 years (including 18 years and 70 years) and not reaching the 71st birthday were all considered to be ≤70 years old;
Expected survival ≥12 weeks;
Eastern Cooperative Oncology Group(ECOG) physical condition 0 or 1;
For female subjects of child-bearing age women agreed to study during treatment and experimental subjects within 6 months after the end of the treatment period using an approved by the medical contraception (e.g. intrauterine device, the pill or condoms), before the study drug delivery within 7 days of pregnancy blood test must be negative (sterilization surgery or age 60 or more subjects can choose no pregnancy blood test), and must be an lactation. For male subjects: should be sterilized surgically, or agree to use a medically approved contraceptive method during the study period and for 6 months after the end of the treatment period. Control subjects after the end of the treatment period according to the choice of control drugs to determine the length of contraception.

Key exclusion criteria (19 listed)

Received chemotherapy within 4 weeks before the start of study administration (treatment with nitrosourea and mitomycin C within 6 weeks, oral fluorouracil within 2 weeks), radiotherapy (palliative for bone metastases Local radiotherapy is within 2 weeks before study administration), immunotherapy; received endocrine therapy for breast cancer within 2 weeks before study administration;
The research drug was used within 4 weeks before the start of study administration;
Have undergone major surgery within 4 weeks before the start of study administration;
Have received a live vaccine within 4 weeks before the start of study administration or plan to receive any vaccine during the study period;
Serious cardiovascular and cerebrovascular events occurred within 12 months, including but not limited to unstable angina, myocardial infarction, cerebral hemorrhage, and cerebral infarction (except for asymptomatic and untreated lacunar infarction)；

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
RC48-ADCAlso: RC48RC48-ADC 2.0mg / kg, intravenous drip, once every 2 weeks	Drug	RC48-ADC
Paclitaxel InjectionAlso: TaxolAdministered according to label, as one option for Physician's Choice (determined before randomization)	Drug	Physician's Choice
Docetaxel InjectionAlso: TaxotereAdministered according to label, as one option for Physician's Choice (determined before randomization)	Drug	Physician's Choice
Vinorelbine Tartrate InjectionAlso: NavelbineAdministered according to label, as one option for Physician's Choice (determined before randomization)	Drug	Physician's Choice
Capecitabine TabletsAlso: XelodaAdministered according to label, as one option for Physician's Choice (determined before randomization)	Drug	Physician's Choice

Primary outcome

Progression-free survival (PFS), evaluated by an independent efficacy evaluation committee
Time frame: within approximately 3 years
Progression-free survival (PFS) refers to the time from the date of randomization to the first researcher's evaluation of disease progression or death (calculated by the event that occurred first). The disease progression will be evaluated by the researchers according to the RECIST 1.1 standard.

6 secondary outcomes

Progression-free survival (PFS), evaluated by the investigator
Time frame: within approximately 3 years
Objective remission rate (ORR)
Time frame: within approximately 3 years
Duration of relief (DOR)
Time frame: within approximately 3 years
Disease control rate (DCR)
Time frame: within approximately 3 years
Tumor progression time (TTP)
Time frame: within approximately 3 years
Overall survival (OS)
Time frame: within approximately 3 years

Results and safety

This study is still under way. Results are not available in the source record yet.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 23 Sep 2026.
Individual participant dataSharing planned: No

Related trials for Breast Cancer

Active, not recruitingPhase 1/2
Phase I/II Study of the Anti-Programmed Death Ligand-1 Durvalumab Antibody (MEDI4736) in Combination With Olaparib and/or Cediranib for Advanced Solid Tumors and Advanced or Recurrent Ovarian, Triple Negative Breast, Lung, Prostate and Colorectal Can...
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A Study Evaluating the Efficacy and Safety of Multiple Treatment Combinations in Patients With Metastatic or Locally Advanced Breast Cancer
Metastatic Breast Cancer
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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.

Binghe Xu, M.D. contact

010-87788826

bhxu@hotmail.com

Binghe Xu principal investigator

Oncology Hospital, Chinese Academy of Medical Sciences

Tao Sun principal investigator

Liaoning Cancer Hospital & Institute

Wei Li principal investigator

Jilin University First Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 3 study testing RC48-ADC, Paclitaxel Injection and Docetaxel Injection in people with Breast Cancer, run by RemeGen Co., Ltd. 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 23 inclusion and 19 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 23 Sep 2026. 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 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?

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 Binghe Xu, M.D. (010-87788826, bhxu@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Progression-free survival (PFS), evaluated by an independent efficacy evaluation committee (time frame: within approximately 3 years). 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 NCT04400695.

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 23 Sep 2026; AzTrials last refreshed its copy on 8 Nov 2026.