Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer
Active, enrolledPhase 2Results postedLast updated 3 June 2025
What this trial tests
Phase 2 trial testing pertuzumab in HER2-positive Breast Cancer in 63 participants. Participants enrolled and being followed up; not accepting new ones.
19 and older, female only, with HER2-positive Breast Cancer or Recurrent Breast Cancer. Patients with the condition only — healthy volunteers not accepted.
Results — posted to ClinicalTrials.gov
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
Progression Free Survival (MBC Cohort)Primary· assessed up to 5 years
Estimated using the product-limit method of Kaplan and Meier. From time of initial treatment until disease progression or death. Progression is defined using Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1), as a 20% increase in the sum of the longest diameter of target lesions, or a measurable increase in a non-target lesion, or the appearance of new lesions.
Group
Value
95% CI
Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients
22.4
7.1 – NA
Five Year Disease-free Survival (LABC Cohort)Primary· assessed up to 5 years
Estimated using the method of Kaplan-Meier. Disease-free survival is defined as the time from Initial treatment to recurrence of tumor or death
Group
Value
95% CI
Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients
96.3
76.5 – 99.5
Overall Response (MBC Cohort)Secondary· Up to 5 years
Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.1) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), \>=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR
Group
Value
95% CI
Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients
13
Five Year Overall SurvivalSecondary· Assessed up to 5 years
Estimated by the Kaplan-Meier method. From the initial date of treatment to date of death from any cause.
Group
Value
95% CI
Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients
54.5
8.6 – 86.1
Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients
94.1
77.6 – 98.5
Adverse events — posted to ClinicalTrials.gov
Time frame: Adverse events were assessed from the time of initial treatment until 30 days post discontinuation of treatment, up to 5 years..
Reporting threshold: 0%.
Adverse-event reports describe events observed during the trial — not all are caused by the drug.
Cohort1: Stage IV HER-2 Overexpressing Metastatic Breast Cancer (MBC) Patients
Serious: 3/18 (17%)
Deaths: 8/18
Cohort 2: HER2+ Locally Advanced Breast Cancer (LABC) Patients
Serious: 4/45 (9%)
Deaths: 2/45
Serious adverse events (11 terms)
Reaction
System
Cohort1: Stage IV HER-2 Ov…
Cohort 2: HER2+ Locally Ad…
Dyspnea
Respiratory, thoracic and mediastinal disorders
—
—
Thromboembolic event
Vascular disorders
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Atrial fibrillation
Cardiac disorders
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Cardiac disorders - Other, specify
Cardiac disorders
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Blurred vision
Eye disorders
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Edema limbs
General disorders
—
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Catheter related infection
Infections and infestations
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Creatinine increased
Investigations
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Hyponatremia
Metabolism and nutrition disorders
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Metabolism and nutrition disorders - Oth
Metabolism and nutrition disorders
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Respiratory, thoracic and mediastinal di
Respiratory, thoracic and mediastinal disorders
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Other adverse events (185 terms — click to expand)
This phase II trial studies how well pertuzumab, trastuzumab, and paclitaxel albumin-stabilized nanoparticle formulation work in treating patients with human epidermal growth factor receptor (HER) 2-positive stage II-IV breast cancer. Monoclonal antibodies, such as pertuzumab and trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Drugs used in chemotherapy, such as paclitaxel albumin-stabilized nanoparticle formulation, work in different ways to kill tumor cells or stop them from growing. Giving pertuzumab and trastuzumab together with paclitaxel albumin-stabilized nanoparticle formulation may be a better way to block tumor growth.
Publications & conference data
8 peer-reviewed publications reference this trial (live from Europe PMC):
NCT04683445 — Efficacy and Safety of Eribulin in the Treatment of Advanced Breast Cancer
· unknown
NCT02947685 — Randomized, Open Label, Clinical Study of the Targeted Therapy, Palbociclib, to Treat Metastatic Breast Cancer
· Phase 3
· active not recruiting
NCT01875666 — Defining the HER2 Positive (+) Breast Cancer Kinome Response to Trastuzumab, Pertuzumab, Combination Trastuzumab +Pertuz
· EARLY_PHASE1
· completed
Other recruiting trials for HER2-positive Breast Cancer
Currently open trials in the same condition.
NCT07459673 — HERizon-Breast: A ctDNA-Guided Adaptive Study of Sequential Anti-HER2 Therapies and CNS Prophylaxis to Induce Long-Term
· Phase 2
· recruiting
NCT07377643 — IBI354 With or Without Pertuzumab Versus Taxane, Trastuzumab and Pertuzumab in HER2-positive Metastatic Breast Cancer
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· recruiting
NCT07510802 — Dual-Target CAR-NK Cells for Advanced Breast Cancer HER2+ TNBC
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· recruiting
NCT07486089 — Dual-Target CAR-NK Cells for Advanced Breast Cancer (HER2+ and TNBC)
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· recruiting
NCT07102381 — A Phase 2 Neoadjuvant Study of Zanidatamab in Combination With Chemotherapy in Participants With HER2-positive Breast Ca
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Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
Sponsor: as reported to ClinicalTrials.gov by City of Hope Medical Center
Last refreshed: 3 June 2025
Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT01730833.