Study investigating new drug, IMC-1121B, in patients with advanced breast cancer who have not yet been treated with drugs for breast cancer that has returned or is growing again and can not be removed by surgery, or that has spread to different parts of the body. Study has two groups: All patients will be treated with docetaxel. In addition, one group will receive IMC-1121B, the other group an inactive substance. Neither the patient nor the doctor will know the treatment group.
- Conditions
- HER2-Negative, Unresectable, Locally-Recurrent or Metastatic Breast CancerMedDRA version: 19.0Level: LLTClassification code 10027475Term: Metastatic breast cancerSystem Organ Class: 100000004864Therapeutic area: Diseases [C] - Cancer [C04]
- Registration Number
- EUCTR2008-001727-65-PL
- Lead Sponsor
- ImClone LLC
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Recruiting
- Sex
- Female
- Target Recruitment
- 1113
Each patient must meet the following criteria to be randomized in this study:
1. The patient is able to provide signed informed consent.
2. The patient is female and = 18 years of age or older if required by local laws or regulations.
3. The patient has histologically or cytologically confirmed adenocarcinoma of the breast that is now metastatic or locally-recurrent and inoperable with curative intent. Every effort should be made to make paraffin-embedded tissue or slides from the diagnostic biopsy or surgical specimen available for confirmation of diagnosis.
4. The patient has measurable and/or non-measurable disease.
5. The patients’ primary and/or metastatic tumor is HER2-negative by fluorescence in situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC).
6. The patient has not received prior chemotherapy for metastatic or locally recurrent and inoperable breast cancer.
7. The patient completed (neo) adjuvant taxane therapy at least 6 months prior to randomization.
8. The patient completed (neo) adjuvant biologic therapy at least 6 weeks prior to randomization.
9. The patient completed all prior radiotherapy with curative intent = 3 weeks prior to randomization.
10. The patient may have received prior hormonal therapy for breast cancer in the (neo) adjuvant and/or the metastatic setting provided it was discontinued = 2 weeks prior to randomization.
11. The patient’s left ventricular ejection fraction is within normal institutional ranges.
12. The patient has resolution to grade = 1 by the National Cancer Institute Common Terminology Criteria for Adverse Events, Version 3 (NCI-CTCAE v 3.0) of all clinically significant toxic effects of prior chemotherapy, surgery, radiotherapy, or hormonal therapy with the exception of peripheral neuropathy which must have resolved to grade = 2.
13. The patient has an Eastern Cooperative Oncology Group (ECOG) performance status of 0-1.
14. The patient is amenable to compliance with protocol schedules and testing.
15. The patient has adequate hematological functions (absolute neutrophil count [ANC] = 1500 cells/mL, hemoglobin = 9 g/dL, and platelets = 100,000 cells/mL and
= 850,000 cells/mL).
16. The patient has adequate hepatic function (bilirubin within normal limits [WNL], or below the upper limit of normal [ULN], aspartate transaminase [AST] and alanine transaminase [ALT] = 2.5 times the upper limit of normal [ULN], or = 5.0 times the ULN if the transaminase elevation is due to liver metastases, and alkaline phosphatase = 5.0 times the ULN).
17. The patient has serum creatinine = 1.5 x ULN. If serum creatinine > 1.5 x ULN the
calculated creatinine clearance should be > 40 mL/min).
18. The patient’s urinary protein is = 1+ on dipstick or routine urinalysis (UA); if urine
protein = 2+, a 24-hour urine collection must demonstrate < 1000 mg of protein in 24 hours to allow participation in the study.
19. The patient must have adequate coagulation function as defined by international
normalized ratio (INR) = 1.5 and a partial thromboplastin time (PTT) = 1.5 X ULN if not receiving anticoagulation therapy. Patients on full-dose anticoagulation must be on a stable dose of oral anticoagulant or low molecular weight heparin and if on warfarin must have a INR between 2 and 3 and have no active bleeding (defined as within 14 days of randomization) or pathological condition that carries a high risk of bleeding (eg, tumor
A patient who has any of the following criteria will be excluded from the study:
1. The patient has a concurrent active malignancy other than breast adenocarcinoma,
adequately treated non-melanomatous skin cancer, or other non-invasive carcinoma or in situ neoplasm. A patient with previous history of malignancy is eligible, provided that she has been disease free for > 3 years.
2. The patient has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.
3. The patient has a known sensitivity to agents of similar biologic composition as IMC-1121B or other agents that specifically target VEGF.
4. The patient has a history of chronic diarrheal disease within 6 months prior to randomization.
5. The patient has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (eg, pelvic or abdominal radiation) within 30 days prior to randomization.
6. The patient has participated in clinical trials of experimental agents within 4 weeks prior to randomization.
7. The patient has a history of uncontrolled hereditary or acquired bleeding or thrombotic disorders.
8. The patient has active, high risk bleeding (eg, via gastric ulcers or gastric varices) within 14 days prior to randomization.
9. The patient has an ongoing or active infection requiring parenteral antibiotic, antifungal, or antiviral therapy.
10. The patient has uncontrolled hypertension, symptomatic congestive heart failure, unstable angina pectoris, symptomatic or poorly controlled cardiac arrhythmia, psychiatric illness/social situations, or any other serious uncontrolled medical disorders in the opinion of the investigator.
11. The patient has brain metastases, uncontrolled spinal cord compression, or carcinomatous meningitis, or new evidence of brain or leptomeningeal disease.
12. The patient has known human immunodeficiency virus infection or acquired immunodeficiency syndrome-related illness.
13. The patient has pulmonary lymphangitic involvement that results in pulmonary dysfunction requiring active treatment, including the use of oxygen.
14. The patient is pregnant or lactating.
Study & Design
- Study Type
- Interventional clinical trial of medicinal product
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method
- Secondary Outcome Measures
Name Time Method