CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 226 enrolled
Drug / intervention
doxorubicin hydrochloride +8 moredrug
Likely dose
Doxorubicin and cyclophosphamide (dose-dense formulation) followed by paclitaxel with concurrent bevacizumab; specific doses not stated in criteria or arms.AI-extracted
Key inclusion· 6
  • Histologically confirmed breast adenocarcinoma with axillary or internal mammary lymph node involvement documented by routine H&E staining (not immunohistochemistry alone).
  • Completed definitive breast surgery: mastectomy with axillary dissection, mastectomy with sentinel node biopsy, lumpectomy with axillary dissection, or lumpectomy with sentinel node biopsy.
  • Lumpectomy or mastectomy margins histologically free of invasive breast cancer and DCIS. Margins positive for LCIS are acceptable.
  • ECOG performance status 0-2.
Key exclusion· 12
  • HER2+ breast cancer (3+ by IHC or FISH+).
  • Prior cytotoxic chemotherapy, hormonal therapy, or radiation for this breast cancer. Prior anthracycline, anthracenedione, or taxane for any condition is disqualifying. Prior tamoxifen or raloxifene for chemoprevention allowed if discontinued.
  • Inflammatory breast disease or fixed axillary nodes (N2) at diagnosis.
  • Major surgical procedure within 4 weeks of entry (excluding non-operative biopsy or vascular access device placement).

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

Search/NCT00119262
NCT00119262Phase 2Completed

Phase II Feasibility Trial Incorporating Bevacizumab Into Dose Dense Doxorubicin and Cyclophosphamide Followed by Paclitaxel in Patients With Lymph Node Positive Breast Cancer

National Cancer Institute (NCI)·interventional·Posted Jul 13, 2005·Updated May 15, 2014

In Brief

A Phase 2 clinical trial evaluating doxorubicin hydrochloride, cyclophosphamide, and 7 other interventions for Male Breast Cancer and 3 related conditions. Completed, enrolled 226 participants across 1 site.

Detailed Summary

This phase II trial is studying how well giving bevacizumab together with combination chemotherapy works in treating patients who have undergone surgery for breast cancer that has spread to the lymph nodes. Monoclonal antibodies, such as bevacizumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. Bevacizumab may also stop the growth of tumor cells by blocking blood flow to the tumor. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving bevacizumab together with more than one chemotherapy drug (combination chemotherapy), may be a better way to block tumor growth.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States
Collaborators--

Timeline

Phase 2CompletedFinished
20052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJul 13, 2005
Enrollment StartOct 1, 2005
Primary CompletionAug 1, 2009
Study CompletionSep 1, 2009
TodayJul 2, 2026
Enrollment to primary: 3.8 yearsPosted 21.0 years ago

Interventions

doxorubicin hydrochloridedrug

Given IV

cyclophosphamidedrug

Given IV

bevacizumabbiological

Given IV

paclitaxeldrug

Given IV

filgrastimbiological

Given SC

pegfilgrastimbiological

Given SC

radiation therapyradiation

Undergo radiation therapy

tamoxifen citratedrug

Given orally

aromatase inhibition therapydrug

Receive aromatase inhibition therapy