IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer

NCT07377643 | Recruiting Phase 3 DMC

• 1 other identifier: CIBI354B302
• Study Type: interventional
• Target: 540
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

HER2-positive Breast Cancer

Outcome Measures

Primary Outcomes (1)

• Progression Free Survival (PFS) by Blinded Independent Central Review (BICR) assessment

  Defined as time from date of randomisation until the date of objective radiological disease progression according to Blinded Independent Central Review (BICR) using RECIST 1.1 or death by any cause.

  Until progression or death, up to 54 months

Secondary Outcomes (8)

• Progression Free Survival (PFS) by Investigator assessment

  Until progression or death, up to 54 months

• Overall Survival (OS)

  Until death, up to 54 months

• Objective Response Rate (ORR) by BICR and Investigator assessment

  Until progression or death, up to 54 months

• Duration of Response (DoR) by BICR and Investigator Assessment

  Until progression or death, up to 54 months

• Disease control rate (DCR) by BICR and Investigator assessment

  Until progression or death, up to 54 months

Study Arms (3)

Group A

EXPERIMENTAL

IBI354 plus pertuzumab

Drug: IBI354; Drug: Pertuzumab

Group C

ACTIVE COMPARATOR

THP

Drug: Trastuzumab; Drug: Docetaxel; Drug: Pertuzumab; Drug: Paclitaxel

Group B

EXPERIMENTAL

IBI354

Drug: IBI354

Interventions

Docetaxel DRUG

IV infusion

Group C

Pertuzumab DRUG

IV infusion

Group A; Group C

Paclitaxel DRUG

IV infusion

Group C

Trastuzumab DRUG

IV infusion

Group C

IBI354 DRUG

IV infusion

Group A; Group B

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Note: CNS lesions will not be considered target lesions.
• 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 and pigmentation). Note: Participants with chronic, stable Grade 2 toxicities (defined as not worsening to \>Grade 2 for at least 3 months prior to enrollment and manageable with standard of care) that were considered by the investigator to be related to prior anticancer therapy, e.g., fatigue, insomnia, hypomagnesemia, chemotherapy-induced peripheral neuropathy, hypothyroidism stably controlled by replacement therapy, and hypertension stably controlled below 160/100 mmHg by antihypertensives, were eligible for study entry.
• 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 increase significantly with drain removal or no drainage, for at least 7 days, are allowed).
• 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 high risk for bleeding, have evidence of portal hypertension (including splenomegaly on imaging), or have a history of variceal bleeding, must have endoscopic assessment within 3 months prior to the first start of study treatment.
• 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 history of extensive bowel resection (partial colectomy or extensive small bowel resection accompanied with chronic diarrhea), Crohn's disease, ulcerative colitis, or chronic diarrhea. Note: The digestive tract refers to the muscular tube from the oral cavity to the anal canal, including the oral cavity, pharynx, esophagus, stomach, small intestine (duodenum, jejunum, and ileum), large intestine (cecum, appendix, colon, and rectum), and anal canal.
• 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 negative and hepatitis B e antibody negative), and hepatitis B virus (HBV) DNA ≥ 1 × 10 4 copies/mL or ≥ 2000 IU/mL; or acute or chronic active hepatitis C, defined as hepatitis C virus (HCV) antibody positive and HCV RNA titer above the lower limit of detection.

Sponsors & Collaborators

• Innovent Biopharmaceutical Technology (Hangzhou) Co., LTD.: lead

Study Sites (1)

Chinese Academy of Medical Sciences and Peking Union Medical College

Beijing, Beijing Municipality, 100021, China

RECRUITING

MeSH Terms

Interventions

Trastuzumab; Docetaxel; pertuzumab; Paclitaxel

Intervention Hierarchy (Ancestors)

Antibodies, Monoclonal, Humanized; Antibodies, Monoclonal; Antibodies; Immunoglobulins; Immunoproteins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Serum Globulins; Globulins; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Diterpenes; Terpenes

Central Study Contacts

Xiaodong Sun

CONTACT

0512-69566088-8095; xiaodong.sun@innoventbio.com

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 15, 2026
• First Posted: January 30, 2026
• Study Start: February 10, 2026
• Primary Completion (Estimated): April 28, 2028
• Study Completion (Estimated): May 31, 2030
• Last Updated: February 25, 2026

Record last verified: 2026-02

Locations

CN (1)