At a glance

ClinicalIndex Comparison Record

Phase 2Completed· 82 enrolled

Drug / intervention

trastuzumab +4 morebiological

Likely dose

Doxorubicin 60 mg/m² IV every 3 weeks × 4 cycles; cyclophosphamide 600 mg/m² IV every 3 weeks × 4 cycles; paclitaxel 90 mg/m² IV weekly × 12 weeks (with trastuzumab) or 175 mg/m² IV every 3 weeks × 12 weeks (without trastuzumab); trastuzumab 4 mg/kg load week 1, then 2 mg/kg weekly × 12 weeksAI-extracted

Key inclusion· 5

✓Histologically confirmed stage IIB, IIIA, IIIB, IIIC, or previously untreated stage IV breast cancer
✓Biopsy by fine needle aspiration, core needle biopsy, or incisional biopsy (no excisional biopsy)
✓Tumor meets size/node criteria: T2N1, T3N0, any T with N2 or N3, any T4 (including inflammatory), or supraclavicular/infraclavicular positive nodes without distant metastases, or distant metastases with measurable disease in breast/nodes
✓Measurable or evaluable disease

Key exclusion· 1

✕Prior malignancies except: squamous cell/basal cell skin cancer, in situ cervical carcinoma treated by surgery, or nonbreast malignancy with disease-free survival ≥5 years and low recurrence risk

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

Search/NCT00006110

NCT00006110Phase 2Completed

Compare CT.gov

Nonrandomized Ph II Study of Multimodality Therapy for Stg IIB, IIIA/B, or Stg IV Breast Cancer w/4 Cycles of Adriamycin and Cytoxan (AC),Followed by 12 Weeks of Paclitaxel w/ or w/o Herceptin Followed by Local Therapy Followed by Wkly Herceptin or no Additional Therapy

UNC Lineberger Comprehensive Cancer Center·interventional·Posted Jan 27, 2003·Updated Jul 31, 2017

In Brief

A Phase 2 clinical trial evaluating trastuzumab, cyclophosphamide, and 3 other interventions for Breast Cancer. Completed, enrolled 82 participants across 2 sites.

Detailed Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Monoclonal antibodies such as trastuzumab can locate tumor cells and either kill them or deliver tumor-killing substances to them without harming normal cells. Combining chemotherapy, monoclonal antibody therapy, and surgery may be a more effective treatment for breast cancer. PURPOSE: Phase II trial to study the effectiveness of combination chemotherapy, monoclonal antibody therapy, and surgery in treating women who have stage II, stage III, or stage IV breast cancer.

Study Details

Study Typeinterventional

Allocation--

Masking--

Primary Purpose--

ConditionsBreast Cancer

CountriesUnited States

Collaborators--

Timeline

Phase 2CompletedFinished

19992000200120022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027

Enrollment StartDec 1998

First PostedJan 2003

Primary CompletionMar 2012

Study CompletionApr 2013

TodayJul 2026

First PostedJan 27, 2003

Enrollment StartDec 1, 1998

Primary CompletionMar 1, 2012

Study CompletionApr 1, 2013

TodayJul 2, 2026

Enrollment to primary: 13.3 yearsPosted 23.4 years ago

Interventions

trastuzumabbiological

infusion 4 mg/kg load week 1; 2 mg/kg weekly thereafter for 12 weeks

cyclophosphamidedrug

600 mg/m2, intravenous infusion every 3 weeks for four cycles

doxorubicin hydrochloridedrug

60 mg/m2 intravenously, 5-10 minutes, every 3 weeks, up to 12 weeks

paclitaxeldrug

90 mg/m2 weekly, intravenously 1 hour after herceptin, given weekly up to 12 weeks or 175 mg/m2, intravenously every 3 weeks, up to 12 weeks (only if not receiving Herceptin®)

conventional surgeryprocedure

Surgical excision will take place 12-13 weeks for the neo-adjuvant herceptin setting and 12-13 weeks in the non-herceptin setting. Surgery will take place prior to chemotherapy in the adjuvant herceptin setting