Trastuzumab and Pertuzumab in Treating Patients With Unresectable Locally Advanced or Metastatic Breast Cancer That Did Not Respond to Previous Trastuzumab

NCT00301899 | Completed Phase 2

• 4 other identifiers: 06003506-C-0035NCI-P6660CDR0000462639
• Study Type: interventional
• Target: 37
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Monoclonal antibodies, such as trastuzumab and pertuzumab, 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. Giving trastuzumab together with pertuzumab may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving trastuzumab together with pertuzumab works in treating patients with unresectable locally advanced or metastatic breast cancer that did not respond to previous trastuzumab.

Conditions

Breast Cancer

Keywords

recurrent breast cancer; male breast cancer; stage IIIA breast cancer; stage IIIB breast cancer; stage IIIC breast cancer; stage IV breast cancer

Outcome Measures

Primary Outcomes (2)

• Safety

• Minimal rate of clinical responses

Secondary Outcomes (4)

• Time to progression

• Time to response

• Response duration

• Progression-free survival

Interventions

pertuzumab BIOLOGICAL

trastuzumab BIOLOGICAL

Eligibility Criteria

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

DISEASE CHARACTERISTICS: * Histologically confirmed invasive breast cancer of 1 of the following stages: * Metastatic disease (stage IV) * Inoperable locally advanced disease * Disease progression after prior neoadjuvant chemotherapy required * Disease progression on or after trastuzumab (Herceptin®) based-therapy * Received 1-3 prior trastuzumab-based regimens * HER2/neu-positive tumor, defined as 3+ by fluorescent in situ hybridization * Measurable disease, defined as at least 1 lesion that can be measured in at least one dimension * No clinical signs or symptoms of brain and/or leptomeningeal metastases confirmed by CT scan or MRI * Brain and/or leptomeningeal metastases allowed if patient has stable lesions after standard treatment (surgery or radiotherapy), is asymptomatic on neurological exam, and is not receiving corticosteroid therapy to control symptoms * Hormone receptor status: * Not specified PATIENT CHARACTERISTICS: * ECOG performance status 0-1 * Male or female * Menopausal status not specified * Not pregnant or nursing * Negative pregnancy test * Fertile patients must use effective contraception * Absolute neutrophil count ≥ 1,500/mm\^3 * Platelet count ≥ 75,000/mm\^3 * Creatinine ≤ 1.5 times upper limit of normal (ULN) * Bilirubin ≤ 1.5 times ULN * Alkaline phosphatase \< 5 times ULN * AST and ALT ≤ 2.5 times ULN (5 times ULN if liver metastases are present) * LVEF above lower limit of normal by echocardiogram or MRI * No clinical signs or symptoms of heart failure * No uncontrolled hypertension (i.e., blood pressure ≥ 180/100 mm Hg) * No significant valvular disease (i.e., aortic or mitral regurgitation of 3 or 4+/4+ severity or stenosis of either valve) * No history of uncontrolled cardiac arrhythmia * No symptomatic or asymptomatic myocardial infarction * No angina pectoris requiring medication * No other documented significant cardiac event * No poorly controlled diabetes mellitus (i.e., fasting blood sugar ≥ 200 mg/dL) * No history of hypersensitivity reaction to trastuzumab * No AIDS * No nonmalignant condition requiring ≥ 20 mg of prednisone (or equivalent) * No other malignancy within the past 5 years except carcinoma in situ of the cervix or nonmelanoma skin cancer * No ongoing liver disease, including viral or other hepatitis, alcohol abuse, or cirrhosis * No other serious medical illness * No medical or psychiatric condition that would preclude study participation PRIOR CONCURRENT THERAPY: * See Disease Characteristics * Recovered from prior therapy * More than 3 weeks since prior investigational anticancer agents * More than 4 weeks since prior chemotherapy (6 weeks for nitrosoureas or mitomycin C), major surgery, or immunotherapy * More than 4 weeks since prior radiotherapy except short-course palliative radiotherapy for bone pain * More than 2 weeks since prior and no concurrent oral hormonal therapy * More than 4 weeks since prior fulvestrant * No prior doxorubicin hydrochloride or doxorubicin HCl liposome at a cumulative dose of \> 360 mg/m\^2 * No prior mitoxantrone hydrochloride at a cumulative dose of \> 120 mg/m\^2 * No prior epirubicin hydrochloride at a cumulative dose of \> 600 mg/m\^2 * No prior idarubicin at a cumulative dose of \> 90 mg/m\^2 * No concurrent radiation therapy, including for symptomatic bone metastases

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• National Institutes of Health Clinical Center (CC): lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

Warren Grant Magnuson Clinical Center - NCI Clinical Trials Referral Office

Bethesda, Maryland, 20892-1182, United States

Location

Related Publications (1)

• Baselga J, Gelmon KA, Verma S, Wardley A, Conte P, Miles D, Bianchi G, Cortes J, McNally VA, Ross GA, Fumoleau P, Gianni L. Phase II trial of pertuzumab and trastuzumab in patients with human epidermal growth factor receptor 2-positive metastatic breast cancer that progressed during prior trastuzumab therapy. J Clin Oncol. 2010 Mar 1;28(7):1138-44. doi: 10.1200/JCO.2009.24.2024. Epub 2010 Feb 1.

  PMID: 20124182 RESULT

MeSH Terms

Conditions

Breast Neoplasms; Breast Neoplasms, Male

Interventions

pertuzumab; Trastuzumab

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

Study Officials

• Chia Portera, MD

  NCI - Medical Oncology Branch

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 2
• Masking: NONE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: March 9, 2006
• First Posted: March 13, 2006
• Study Start: December 1, 2005
• Study Completion: October 1, 2007
• Last Updated: March 8, 2012

Record last verified: 2012-03

Locations

US (1)