Safety and Efficacy Study of the Trifunctional Antibody Ertumaxomab to Treat Patients With Advanced or Metastatic Breast Cancer

NCT00351858 | Terminated Phase 2

• 2 other identifiers: FBT-IVREXBC 02EudraT number: 2005-004294-21
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

Brief Summary

The purpose of this study is to determine the safety and efficacy of the investigational trifunctional anti-Her-2/neu x anti-CD3 antibody ertumaxomab as treatment for hormone therapy refractory Her-2/neu 1+ or 2+ expressing advanced or metastatic breast cancer

Conditions

Breast Neoplasms; Breast Cancer

Keywords

Breast Cancer; investigational drug; drug therapy; Antineoplastic Protocols; Immunotherapy; Metastatic breast cancer; Advanced breast cancer; Stage III to IV breast cancer; Hormonal therapy refractory; Failure of hormonal therapy; Her-2/neu expressing breast cancer; low to moderate Her-2/neu expression

Outcome Measures

Primary Outcomes (1)

• To demonstrate clinical efficacy of the investigational trifunctional antibody ertumaxomab for the treatment of hormone therapy refractory advanced or metastatic breast cancer tumors (stage IIIb or IV) which are known to express Her-2/neu (1+ or 2+)

Secondary Outcomes (5)

• Time to progression

• Duration of response

• Time to response

• Clinical benefit of ertumaxomab (defined as the rate of confirmed complete remission, partial remission and stable disease)

• Tumor marker levels (CA 15-3 and CEA)

Interventions

ertumaxomab DRUG

Eligibility Criteria

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

You may qualify if:

• Female gender, and if of child-bearing potential must have negative pregnancy test result within 2 days before enrolment and must agree to practice effective birth control during the study.
• Aged 18 years and older.
• Histologically or cytologically confirmed invasive breast cancer with stage IIIb or IV disease with documented progression.
• Measurable disease according to RECIST.
• Histologically documented advanced primary breast cancer or biopsy of metastatic site demonstrating HER-2/neu expression (HER-2/neu 1+ or 2+, determined by immunohistochemistry \[IHC\]). HER-2/neu 2+ patients must have a negative Fluorescence In Situ Hybridization \[FISH\] test result.
• Hormone receptor status Estrogen Receptors (ERs) positive and/or Progesterone Receptors (PRs) positive.
• No prior treatment with mouse or rat antibodies.
• Life expectancy of at least six months (if the life expectancy of a patient is unspecified she will be allowed to enter the study).
• An Eastern Cooperative Oncology Group (ECOG) performance score of £ 1.
• Patients must have had disease progression after hormonal therapy including at least one aromatase inhibitor.
• Adequate hematological, liver and kidney function:
• Thrombocytes ³ 100000 / mm³ (= 100 x 109 /l)
• Hemoglobin ³ 10 g/dl
• Neutrophil count ³ 1500/mm³ (= 1.5 x 109 /l)
• WBC ³ 3 X 109 /l

Sponsors & Collaborators

• Neovii Biotech: lead

Study Sites (1)

Jules Bordet Institute, Free University of Brussels

Brussels, 1000, Belgium

Location

Related Publications (6)

• Kiewe P, Hasmuller S, Kahlert S, Heinrigs M, Rack B, Marme A, Korfel A, Jager M, Lindhofer H, Sommer H, Thiel E, Untch M. Phase I trial of the trifunctional anti-HER2 x anti-CD3 antibody ertumaxomab in metastatic breast cancer. Clin Cancer Res. 2006 May 15;12(10):3085-91. doi: 10.1158/1078-0432.CCR-05-2436.

  PMID: 16707606 BACKGROUND

• Lindhofer H, Mocikat R, Steipe B, Thierfelder S. Preferential species-restricted heavy/light chain pairing in rat/mouse quadromas. Implications for a single-step purification of bispecific antibodies. J Immunol. 1995 Jul 1;155(1):219-25.

  PMID: 7602098 BACKGROUND

• Zeidler R, Reisbach G, Wollenberg B, Lang S, Chaubal S, Schmitt B, Lindhofer H. Simultaneous activation of T cells and accessory cells by a new class of intact bispecific antibody results in efficient tumor cell killing. J Immunol. 1999 Aug 1;163(3):1246-52.

  PMID: 10415020 BACKGROUND

• Zeidler R, Mysliwietz J, Csanady M, Walz A, Ziegler I, Schmitt B, Wollenberg B, Lindhofer H. The Fc-region of a new class of intact bispecific antibody mediates activation of accessory cells and NK cells and induces direct phagocytosis of tumour cells. Br J Cancer. 2000 Jul;83(2):261-6. doi: 10.1054/bjoc.2000.1237.

  PMID: 10901380 BACKGROUND

• Ruf P, Lindhofer H. Induction of a long-lasting antitumor immunity by a trifunctional bispecific antibody. Blood. 2001 Oct 15;98(8):2526-34. doi: 10.1182/blood.v98.8.2526.

  PMID: 11588051 BACKGROUND

• Zeidler R, Mayer A, Gires O, Schmitt B, Mack B, Lindhofer H, Wollenberg B, Walz A. TNFalpha contributes to the antitumor activity of a bispecific, trifunctional antibody. Anticancer Res. 2001 Sep-Oct;21(5):3499-503.

  PMID: 11848515 BACKGROUND

MeSH Terms

Conditions

Breast Neoplasms

Interventions

ertumaxomab

Condition Hierarchy (Ancestors)

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

Study Officials

• Fatima Cardoso, MD

  Brussels

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY

Study Record Dates

• First Submitted: July 12, 2006
• First Posted: July 13, 2006
• Study Start: July 1, 2006
• Study Completion: February 1, 2009
• Last Updated: May 1, 2015

Record last verified: 2015-04

Locations

BE (1)