CI

At a glance

ClinicalIndex Comparison Record
Phase 2Completed· 27 enrolled
Drug / intervention
cyclophosphamide +2 moredrug
Likely dose
Not stated in record
Key inclusion· 6
  • Histologically confirmed adenocarcinoma of the breast
  • Primary tumor ≤4 cm with 0-3 positive axillary lymph nodes (pathologic T1-2, pathologic N0-N1, M0)
  • Segmental mastectomy with level I/II axillary dissection or sentinel lymph node biopsy within past 14 weeks
  • Surgical margins negative (>3 mm) for invasive carcinoma and ductal carcinoma in situ
Key exclusion· 5
  • Squamous cell carcinoma or sarcoma of the breast
  • Prior radiation therapy to the breast
  • Prior trastuzumab (Herceptin)
  • Other malignancy within past 5 years (except adequately treated basal/squamous skin cancer or cervical carcinoma in situ)

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

Search/NCT00278109
NCT00278109Phase 2Completed

Phase I/II Partial Breast Irradiation With Concurrent Chemotherapy

Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins·interventional·Posted Jan 18, 2006·Updated Feb 19, 2020

In Brief

A Phase 2 clinical trial evaluating cyclophosphamide, Doxorubicin, and 1 other intervention for Breast Cancer. Completed, enrolled 27 participants across 1 site.

Detailed Summary

RATIONALE: Radiation therapy uses high-energy x-rays to kill tumor cells. Drugs used in chemotherapy, such as cyclophosphamide and doxorubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving radiation therapy together with cyclophosphamide and doxorubicin after surgery may kill any tumor cells that remain. PURPOSE: This phase I/II trial is studying the side effects of radiation therapy when given together with cyclophosphamide and doxorubicin and to see how well they work in treating women with stage I or stage II breast cancer who have undergone surgery.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsBreast Cancer
CountriesUnited States

Timeline

Phase 2CompletedFinished
200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
First PostedJan 18, 2006
Enrollment StartJul 1, 2004
Primary CompletionDec 1, 2016
TodayJul 2, 2026
Enrollment to primary: 12.4 yearsPosted 20.5 years ago

Interventions

cyclophosphamidedrug

chemotherapy

Doxorubicindrug

doxorubicin

radiationradiation

radiation