Pertuzumab, Trastuzumab, and Paclitaxel Albumin-Stabilized Nanoparticle Formulation in Treating Patients With HER2-Positive Advanced Breast Cancer

NCT01730833 | Active Not Recruiting Phase 2 Results DMC

• 4 other identifiers: 12147NCI-2012-02371R01CA166020AACR Grant 12-60-26-WANG
• Study Type: interventional
• Target: 63
• Locations: 1 country
• Sites: 3

Brief Summary

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.

Conditions

HER2-positive Breast Cancer; Recurrent Breast Cancer; Stage IIA Breast Cancer; Stage IIB Breast Cancer; Stage IIIA Breast Cancer; Stage IIIB Breast Cancer; Stage IIIC Breast Cancer; Stage IV Breast Cancer; Breast Adenocarcinoma; Inflammatory Breast Carcinoma

Outcome Measures

Primary Outcomes (2)

• Progression Free Survival (MBC Cohort)

  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.

  assessed up to 5 years

• Five Year Disease-free Survival (LABC Cohort)

  Estimated using the method of Kaplan-Meier. Disease-free survival is defined as the time from Initial treatment to recurrence of tumor or death

  assessed up to 5 years

Secondary Outcomes (2)

• Overall Response (MBC Cohort)

  Up to 5 years

• Five Year Overall Survival

  Assessed up to 5 years

Study Arms (1)

Treatment (pertuzumab, trastuzumab, nab-paclitaxel)

EXPERIMENTAL

Patients receive pertuzumab IV over 30-60 minutes on day 1, trastuzumab IV over 30-90 minutes and paclitaxel albumin-stabilized nanoparticle formulation IV over 30 minutes on days 1, 8, and 15. Courses repeat every 21 days in the absence of disease progression or unacceptable toxicity.

Biological: pertuzumab; Biological: trastuzumab; Drug: paclitaxel albumin-stabilized nanoparticle formulation; Other: laboratory biomarker analysis

Interventions

pertuzumab BIOLOGICAL

Given IV

Also known as: 2C4 antibody, monoclonal antibody 2C4, Perjeta, rhuMAb-2C4

Treatment (pertuzumab, trastuzumab, nab-paclitaxel)

trastuzumab BIOLOGICAL

Given IV

Also known as: anti-c-erB-2, Herceptin, MOAB HER2

Treatment (pertuzumab, trastuzumab, nab-paclitaxel)

paclitaxel albumin-stabilized nanoparticle formulation DRUG

Given IV

Also known as: ABI-007, nab paclitaxel, nab-paclitaxel, nanoparticle albumin-bound paclitaxel

Treatment (pertuzumab, trastuzumab, nab-paclitaxel)

laboratory biomarker analysis OTHER

Optional correlative studies

Treatment (pertuzumab, trastuzumab, nab-paclitaxel)

Eligibility Criteria

• Age: 19 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients must be diagnosed with metastatic cytologically or histologically confirmed adenocarcinoma of the breast with HER2 over-expression or with newly diagnosed locally advanced (including inflammatory) breast cancer (LABC) with stage II-III disease; patients with metastatic (stage IV) disease (MBC) must have measurable lesions
• Women of child-bearing potential and men must agree to use adequate contraception (hormonal or barrier method of birth control or abstinence) prior to study entry and for six months following duration of study participation; should a woman become pregnant or suspect that she is pregnant while participating on the trial, she should inform her treating physician immediately
• Tumor positive or negative for expression of hormone receptors (\< 1% or \> 1%) and overexpressing HER2 by immunohistochemistry (IHC) (3+), or, HER2-amplified by fluorescence in situ hybridization (FISH) or by alternative gene testing
• For patients with LABC, no prior therapy is allowed
• For patients with MBC, prior adjuvant chemotherapy and trastuzumab more than or equal to 12 months prior to enrollment are allowed
• No prior chemotherapy or trastuzumab for treatment of metastatic breast cancer
• Left ventricular ejection fraction (LVEF) \>= 50% (determined by echocardiogram or multigated acquisition scan) within 42 days of treatment
• Eastern Cooperative Oncology Group performance status of 0 or 1
• Hemoglobin \>= 9 g/dl
• Leukocytes \>= 3.0 x 10\^9/L
• Absolute neutrophil count \>= 1.5 x 10\^9/L
• Platelets \>= 100 x 10\^9/L
• Total bilirubin =\< 1.3 mg/dl (institutional upper limit of normal)
• Aspartate aminotransferase (AST) (serum glutamic oxaloacetic transaminase \[SGOT\])/alanine aminotransferase (ALT) (serum glutamate pyruvate transaminase \[SGPT\]) =\< 2 x institutional upper limit of normal
• Creatinine within normal institutional limits or creatinine clearance \> 50 mL/min/1.73 m\^2 for patients with creatinine levels above institutional normal (using Cockcroft-Gault formula)

You may not qualify if:

• Known active hepatitis B or C
• Known active human immunodeficiency virus (HIV)
• Prior breast cancer or other invasive malignancy treated within 5 years
• Pregnancy
• Neuropathy \> grade 1
• Cumulative dose of doxorubicin or equivalent of \> 360 mg/m\^2 during prior adjuvant therapy
• LVEF \< 50% during previous trastuzumab therapy
• Central nervous system metastases
• Another malignancy excluding basal cell skin cancer
• Pregnant women
• Subjects will be excluded who, in the opinion of the investigator, may not be able to comply with the safety monitoring requirements of the study

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (3)

City of Hope Medical Center

Duarte, California, 91010, United States

Location

City of Hope Antelope Valley

Lancaster, California, 93534, United States

Location

City of Hope- South Pasadena Cancer Center

South Pasadena, California, 91030, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

pertuzumab; 2C4 antibody; Trastuzumab; Taxes; Albumin-Bound Paclitaxel; 130-nm albumin-bound paclitaxel

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

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

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• Joanne Mortimer, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 16, 2012
• First Posted: November 21, 2012
• Study Start: July 17, 2013
• Primary Completion: January 12, 2021
• Study Completion (Estimated): May 20, 2026
• Last Updated: June 3, 2025
• Results First Posted: June 28, 2023

Record last verified: 2025-05

Locations

US (3)