OT AVAILABLE

Not Applicable

• Registration Number: PER-034-10
• Lead Sponsor: ImClone LLC,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2010-08-31
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 16

Inclusion Criteria

1)Participant is able to provide signed informed consent
2)Participant is female and ≥ 18 years of age or older if required by local laws or regulations

3)Participant 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)Participant has measurable and/or non-measurable disease

5)Participants´ primary and/or metastatic tumor is human epidermal growth factor receptor 2 (HER2)-negative by fluorescence in-situ hybridization (FISH) or chromogenic in-situ hybridization (CISH) or 0, 1+ overexpression by immunohistochemistry (IHC)

6)Participant completed (neo) adjuvant taxane therapy at least 6 months prior to randomization

Exclusion Criteria

1)Participant 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 participant with previous history of malignancy is eligible, provided that she has been disease free for > 3 years.

2)Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.

3)Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.

4)Participant has a known sensitivity to docetaxel or other drugs formulated with polysorbate 80.

5)Participant has received irradiation to a major bone marrow area as defined as > 25% of bone marrow (such as, pelvic or abdominal radiation) within 30 days prior to randomization

Study & Design

• Study Type: Interventional
• Study Design: Not specified