CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 45 enrolled
Drug / intervention
Bevacizumab +4 moredrug
Likely dose
Bevacizumab 15 mg/kg IV every 21 days (4 cycles concurrently with AC, then 2 cycles with taxane/capecitabine, then 10 cycles postoperatively); Doxorubicin 60 mg/m² IV every 21 days x 4 cycles; Cyclophosphamide 600 mg/m² IV every 21 days x 4 cycles; Docetaxel 75 mg/m² IV every 21 days x 4 cycles; Capecitabine 650 mg/m² orally twice daily days 1-14 every 21 days x 4 cyclesAI-extracted
Key inclusion· 6
  • ✓Female patients ≥18 years old
  • ✓Invasive adenocarcinoma of breast diagnosed by core needle or limited incisional biopsy
  • ✓Clinical Stage IIIA, IIIB, or IIIC disease with primary tumor ≥2.0 cm by clinical exam (or inflammatory breast carcinoma without measurability requirement)
  • ✓Ability to swallow oral medication
Key exclusion· 11
  • ✕HER2-positive disease (3+ by immunohistochemistry or positive by FISH)
  • ✕Excisional biopsy for primary tumor
  • ✕Synchronous bilateral invasive breast cancer
  • ✕Surgical axillary staging procedure prior to entry (except FNA or sentinel node biopsy for clinically negative nodes)

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT00365417
NCT00365417Phase 2Completed
CompareCT.gov

A Phase II Clinical Trial of Bevacizumab Beginning Concurrently With a Sequential Regimen of Doxorubicin and Cyclophosphamide Followed by Docetaxel and Capecitabine as Neoadjuvant Therapy Followed by Postoperative Bevacizumab Alone for Women With Locally Advanced Breast Cancer

NSABP Foundation Inc·interventional·Posted Aug 17, 2006·Updated Apr 13, 2021

In Brief

A Phase 2 clinical trial evaluating Bevacizumab, Doxorubicin, and 3 other interventions for Breast Cancer. Completed, enrolled 45 participants across 1 site.

Detailed Summary

Bevacizumab is an angiogenesis inhibitor which means it works to stop blood vessel formation in tumors. Without new blood vessels, the growth of a tumor is slowed. Chemotherapy drugs kill cancer cells more directly. This study will evaluate: * How bevacizumab, given with chemotherapy before surgery, and then bevacizumab given alone after surgery, will affect locally advanced breast tumors * Side effects from adding bevacizumab to chemotherapy * Whether adding bevacizumab to chemotherapy for breast cancer will affect the heart * If receiving bevacizumab will have any effect on how patients recover from surgery * Side effects of the combinations of drugs used in this study

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States
CollaboratorsGenentech, Inc., Hoffmann-La Roche, International Drug Development Institute

Timeline

Phase 2CompletedFinished
200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedAug 17, 2006
Enrollment StartAug 1, 2006
Primary CompletionFeb 1, 2008
Study CompletionNov 1, 2009
TodayJul 1, 2026
Enrollment to primary: 1.5 yearsPosted 19.9 years ago

Interventions

Bevacizumabdrug

15 mg/kg IV every 21 days x 4 cycles, then after clinical response assessment, 15 mg/kg IV every 21 days x 2 cycles, then following surgery, 15 mg/kg every 21 days x 10 cycles

Doxorubicindrug

60 mg/m\^2 IV every 21 days x 4 cycles

Cyclophosphamidedrug

600 mg/m\^2 IV every 21 days x 4 cycles

Capecitabinedrug

Following clinical response assessment, 650 mg/m\^2 twice a day (orally), days 1-14 every 21 days x 4 cycles

Docetaxeldrug

Following clinical response assessment, 75 mg/m\^2 IV every 21 days x 4 cycles