apatinib In Chemotherapy-Naive Or Metastatic Breast Cancer

Not Applicable

• Conditions: -C501 Central portion of breast; Central portion of breast; C501

• Registration Number: PER-027-04
• Lead Sponsor: GLAXOSMITHKLINE PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2004-06-11
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

Histologically confirmed invasive breast cancer with incurable stage IIIB, IIIC with T4 lesion or stage IV disease at primary diagnosis or at relapse after curative intent surgery.
Eastern Cooperative Oncology Group (ECOG) performance status 0 or 1.
Documented amplification of ErbB2 by Fluorescence in situ hybridization (FISH)
Measurable disease by Response Evaluation Criteria In Solid Tumors (RECIST)
Adequate renal, hepatic and cardiac function

Exclusion Criteria

Prior chemotherapy, immunotherapy, biologic therapy or anti-ErbB1/ErbB2 therapy other than adjuvant therapy. [Prior neo-adjuvant or adjuvant therapy (including trastuzumab) will be allowed provided it was stopped at least 12 months before study entry.
Patients with active brain metastases
Patients with bilateral breast cancer, bone metastases as the only disease site or metastases to more than 30% of the hepatic parenchyma.

Study & Design

• Study Type: Interventional
• Study Design: Not specified