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Compares treatment options for HER2-positive Breast Cancer
Official title IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
ClinicalTrials.gov ID: NCT07377643
What this study is testing
What is Trastuzumab?
Trastuzumab is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for her2-positive breast cancer.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- This is a randomized, multicenter, open-label, phase 3 study evaluating the efficacy, safety, and tolerability of IBI354 combined with or without pertuzumab vs. THP as first-line treatment for HER2-positive unresectable, locally advanced or metastatic breast cancer.
- Phase 3: a large, late-stage study
- Which group you join is decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- Participants are eligible to be included in the study only if they meet all of the following criteria:
- Have signed the informed consent form (ICF) and are able to comply with the follow-up visits and related procedures required in the protocol.
- Male or female participants: ≥18 years of age
- Pathologically confirmed breast cancer:
- Unresectable, locally advanced or metastatic breast cancer, i.e. participants who cannot be treated with curative intent and confirmed HER2-positive...
See the full eligibility criteria
Who can join
- Participants are eligible to be included in the study only if they meet all of the following criteria:
- Have signed the informed consent form (ICF) and are able to comply with the follow-up visits and related procedures required in the protocol.
- Male or female participants: ≥18 years of age
- Pathologically confirmed breast cancer:
- Unresectable, locally advanced or metastatic breast cancer, i.e. participants who cannot be treated with curative intent and confirmed HER2-positive (HER2 IHC 3+ or HER2 ISH+) on specimens taken after confirmed locally...
- Documented history of hormone receptor (HR)-positive (defined as estrogen receptor [ER] and/or progesterone receptor [PgR] positive [ER or PgR ≥1%]) or HR-negative after local testing in the metastatic setting according...
- No prior chemotherapy or HER2-targeted therapy for unresectable, locally advanced or metastatic breast cancer (first-line endocrine therapy is allowed for patients with metastatic breast cancer). Participants who have...
- Eastern Cooperative Oncology Group Performance Status (ECOG PS) score of 0 or 1.
- Evidence of radiographic or objective disease progression on or after the last systemic therapy prior to starting study treatment.
- Have a life expectancy of ≥12 weeks at screening.
- At least 1 measurable lesion as defined per RECIST v1.1 that has not been previously irradiated. Must be ≥ 10 mm in long axis (except for lymph nodes, which must be ≥ 15 mm in short axis) when accurately measured at...
- Left ventricular ejection fraction (LVEF) ≥ 50% within 28 days prior to randomization.
- Adequate organ and bone marrow function. Laboratory test values within 7 days prior to the first dose of the investigational product meet the following requirements in (if the laboratory tests during the screening...
- Hemoglobin (HGB) ≥ 90 g/L (transfusion of red blood cells or erythropoietin are not allowed within 1 week prior to the screening assessment, and participants requiring ongoing transfusion or growth factor support to...
- Absolute neutrophil count (ANC) ≥ 1.5 × 109 /L or within the normal range (G-CSF is not allowed within 1 week prior to the screening assessment).
- Platelet (PLT) ≥ 90 × 109 /L (transfusion with platelets or thrombopoietin is not allowed within 1 week prior to screening assessment, participants requiring thrombopoietic growth factors to maintain adequate platelet...
- Total bilirubin (TBIL) ≤ 1.5 × upper limit of normal (ULN) in the absence of liver metastasis; TBIL \< 3 × ULN in the presence of Gilbert syndrome (unconjugated hyperbilirubinemia) or liver metastasis.
- Alanine aminotransferase (ALT) and aspartate aminotransferase (AST) ≤3×ULN (\<5×ULN for participants with liver metastases).
- Serum albumin ≥ 25 g/L.
- Serum creatinine ≤ 1.5 × ULN, or creatinine clearance ≥ 60 mL/min ( calculated using the Cockcroft-Gault formula ); if urinalysis indicates that the urine protein is \< 2+, participants with urine protein ≥ 2+ from...
- International normalized ratio (INR) ≤ 1.5 × ULN, and prothrombin time (PT) or activated partial thromboplastin time (APTT) ≤ 1.5 × ULN.
- Participants with evidence of postmenopausal status or negative serum pregnancy test (Sexually active, WOCBP with a non-sterilized male partner) must have a negative serum pregnancy test at the screening visit. WOCBP...
- Female participants of childbearing potential or male participants with partners of childbearing potential must take effective contraceptive measures during the entire course of the trial and 6 months after the...
- Prior treatment with antibody-drug conjugates containing camptothecin or its derivatives (topoisomerase I inhibitors).
- Uncontrolled or significant cardiovascular and cerebrovascular diseases, including any of the following:
- History of myocardial infarction or symptomatic congestive heart failure (New York Heart Association [NYHA] class II to IV) or uncontrolled myocarditis within 6 months before randomization. Participants with troponin...
- Uncontrolled hypertension (systolic blood pressure ≥ 160 mmHg or diastolic blood pressure ≥ 100 mmHg) despite of standard treatment.
- History of any arterial thromboembolic events within 6 months prior to randomization, including myocardial infarction, unstable angina, cerebrovascular accident, or transient ischemic attack.
- History of deep vein thrombosis, pulmonary embolism, or any other serious thromboembolic events within 3 months prior to randomization (thrombosis or catheter-derived thrombosis of caused by implanted venous ports, or...
- History of arrhythmia (polymorphic premature ventricular contractions, bigeminy, trigeminy, ventricular tachycardia, ventricular fibrillation, torsades de pointes) that is symptomatic or requires treatment (CTCAE 5.0...
- Fridericia-corrected QT interval (QTcF) \>480 msec. If QTcF is \> 480 ms in 1 ECG during the screening period, 3 consecutive ECGs should be performed and the mean QTcF should be calculated. If QTcF is still \> 480 ms...
- History of QT prolongation associated with other drugs that require discontinuation, or any current concomitant medication known to prolong QT interval leading to Torsade de Pointes.
- Congenital long QT syndrome, family history of long QT syndrome, or unexplained sudden death in first-degree relatives under 40 years old.
- Non-infectious pneumonitis that requires corticosteroid treatment, or other clinically significant lung diseases such as a history of interstitial lung disease (ILD)/non-infectious pneumonitis, current...
- Have a lung-specific intercurrent clinically significant illness including, but not limited to, any underlying pulmonary disorder (e.g., pulmonary embolism within 3 months prior to study randomization, severe asthma...
- Prior to the first dose of study drug:
- Antibody-based anticancer therapy within 4 weeks, except for receptor activator of nuclear factor-κb ligand (RANKL) inhibitors (eg, denosumab for the treatment of complications resulting from bone metastases).
- Hormonal therapy or immunotherapy (based on non-antibody therapy) within 3 weeks.
- Fixed-field palliative radiotherapy within 2 weeks, or wide-field palliative radiotherapy within 4 weeks or palliative radiotherapy cumulatively exceeding 30% of bone marrow.
- Received oral chemotherapy drugs, small molecule targeted drugs, and Chinese herbal medicines indicated for anti-tumor treatment within 2 weeks or 5 half-lives (whichever is longer).
- Had major surgery (craniotomy, thoracotomy, or laparotomy, and other types of surgery considered "major" by the investigator, excluding needle biopsy and vascular access) or major traumatic injury within 4 weeks, or...
- Treatment with strong inhibitors or inducers of cytochrome P450 3A4 (CYP3A4) within 2 weeks or 5 half-lives (whichever is longer).
- Live vaccines (mRNA and non-replicating adenovirus vaccines are not considered live) within 4 weeks.
- Participants who had used immunosuppressive medications within 14 days prior to the first dose of study drug, with the exception of intranasal and inhaled corticosteroids or systemic corticosteroids at doses of less...
- Known symptomatic central nervous system (CNS) metastasis and/or spinal cord compression and/or carcinomatous meningitis, or a history of leptomeningeal carcinoma. Participants with asymptomatic CNS metastases (without...
- Non-remission of adverse events (AEs) after previous anti-cancer treatment, defined as AEs that have not been relieved to ≤ grade 1 or baseline before enrollment according to NCI-CTCAE v5.0 criteria (except for alopecia...
- Tumor invades surrounding important tissues and organs (such as mediastinal great vessels, superior vena cava and inferior vena cava, pericardium, heart, trachea, esophagus, etc.).
- Bleeding within 3 months prior to the first dose of study treatment that is life-threatening and requires blood transfusion or invasive treatment.
- Symptomatic abdominopelvic fluid collections, pleural effusions, or pericardial effusions requiring intervention (participants with stable controlled effusions, defined as clinically asymptomatic effusions that do not...
- Participants with varices in the esophagus or stomach that require immediate intervention (e.g., ligation or sclerotherapy), or who are considered by the investigator or a gastroenterologist or hepatologist to be at...
- Unhealed gastrointestinal obstruction, perforation, or fistula, or participants at risk of gastrointestinal obstruction or perforation (including but not limited to acute diverticulitis and abdominal abscess), or a...
- After endoluminal stenting of the trachea and after stenting of the digestive tract, and the participant did not resume normal diet or defecation.
- Participants with biliary obstruction, unless local treatment for obstruction (e.g., endoscopic stent placement or percutaneous liver drainage) has been performed and TBIL has decreased to less than 1.5 × ULN.
- Hepatic encephalopathy, hepatorenal syndrome, or cirrhosis with Child-Pugh Class B or above.
- Significant malnutrition, such as malnutrition requiring parenteral nutrition; except for those who have not used intravenous nutrition within 4 weeks before the first study treatment.
- Uncontrolled active infection, including the following:
- Infection requiring systemic antibiotic, antiviral, or antifungal therapy.
- Human immunodeficiency virus (HIV) infection, or positive for HIV 1/2 Ab.
- Acute or chronic active hepatitis B, defined as hepatitis B surface antigen positive (regardless of the results of antibodies to other antigens) or hepatitis B core antibody positive only (hepatitis B surface antibody...
- Active tuberculosis infection, or still receiving anti-tuberculosis treatment, or received anti-tuberculosis treatment within 1 year before the first dose of study drug.
- Active syphilis infection or latent syphilis requiring treatment.
- History of immunodeficiency diseases, including congenital or acquired immunodeficiency diseases.
- History of allogeneic organ transplantation, allogeneic bone marrow transplantation, or autologous hematopoietic stem cell transplantation (except corneal transplantation).
- Pregnant or lactating (may be considered if breastfeeding is discontinued) female participants, or participants planning to become pregnant.
- Ineligible for any drug under study. Participants with contraindications to trastuzumab, pertuzumab monoclonal antibody, taxanes according to local prescribing information or IBI354 per the IBI354 Investigator's...
- Participant has known allergic or hypersensitivity reactions to the study treatments, camptothecin and its derivatives, other ADCs/anti-HER2 antibodies, and any excipients.
- Complicated with other primary malignant tumors within 3 years or other malignant tumors with active or recurrent risk, excluding radically resected non-melanoma skin cancer (mainly including squamous cell carcinoma of...
- Participation in any other treatment clinical study, except for observational (non-treatment) studies or follow-up period after the end of study treatment in treatment studies.
- Presence of substance abuse (excessive or inappropriate use of drugs, alcohol, or other harmful substances that may lead to physical, psychological, or social problems) or other acute or chronic diseases or laboratory...
- The participant has a neurologic, psychiatric, or psychological illness or social condition that would interfere with trial compliance, substantially increase the risk of adverse events, or prevent the participant from...
The study team makes the final eligibility decision.
Where it's taking place
- Beijing, Beijing Municipality, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Beijing, Beijing Municipality, China. Enter your location above to see the nearest site and check your eligibility.
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BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.