NCT00513292|CompletedPhase 3Results

Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery

A Randomized Phase III Trial Comparing a Neoadjuvant Regimen of FEC-75 Followed by Paclitaxel Plus Trastuzumab With a Neoadjuvant Regimen of Paclitaxel Plus Trastuzumab Followed by FEC-75 Plus Trastuzumab in Patients With HER-2 Positive Operable Breast Cancer

National Cancer Institute (NCI)ClinicalTrials.gov

Compare

5 other identifiers

NCI-2009-00341CDR0000559039ACOSOG-Z1041Z1041U10CA012027

Study Type

interventional

Target

280

Locations

2 countries

Sites

115

Timeline

RegisteredAug 2007

StartedJul 2007

CompletionFeb 2013

Brief Summary

This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. 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. Monoclonal antibodies, such as trastuzumab, 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. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.

Trial Health

On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment

280

participants targeted

Target at P50-P75 for phase_3

Timeline

Completed

Started Jul 2007

Longer than P75 for phase_3

Geographic Reach

2 countries

115 active sites

Status

completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

5.6 years study duration

Study Start

First participant enrolled

July 1, 2007

Completed

1 month until next milestone

First Submitted

Initial submission to the registry

August 6, 2007

Completed

2 days until next milestone

First Posted

Study publicly available on registry

August 8, 2007

Completed

4.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 1, 2012

Completed

9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 21, 2013

Completed

2.6 years until next milestone

Results Posted

Study results publicly available

September 29, 2015

Completed

Last Updated

January 23, 2019

Status Verified

January 1, 2019

Enrollment Period

4.9 years

First QC Date

August 6, 2007

Results QC Date

July 14, 2015

Last Update Submit

January 3, 2019

Conditions

HER2/Neu Positive Stage IA Breast Cancer Stage IB Breast Cancer Stage II Breast Cancer Stage IIIA Breast Cancer

Outcome Measures

Primary Outcomes (1)

pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy
Pathological complete response (pCR) rates will be based on institutional pathology reports. In the final analysis for publication, rates will be based on blinded central review of these institutional pathology reports. The Chi-squared test will be conducted at the two-sided 0.05 level. A 95% confidence interval will be computed for the difference in pCR rates.
Up to 5 years

Secondary Outcomes (8)

Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy
Up to 5 years
Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12
Baseline, at 12 week
Asymptomatic Decreases From Baseline in LVEF at Week 24
Baseline, at 24 week
LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week
At 12 week
Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week
Baseline, at 24 week
+3 more secondary outcomes

Study Arms (2)

FEC-75 then Paclitaxel/trastuzumab

ACTIVE COMPARATOR

Patients receive FEC comprising fluoroucacil IV, epirubicin hydrochloride IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Beginning 21 days after completion of FEC, patients receive paclitaxel IV once weekly and trastuzumab (Herceptin) IV once weekly for 12 weeks. Within 6 weeks after completion of paclitaxel and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab IV once every 3 weeks for up to 52 weeks.

Drug: CyclophosphamideDrug: Epirubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: PaclitaxelProcedure: Therapeutic Conventional SurgeryBiological: Trastuzumab

Paclitaxel/trastuzumab then trastuzumab/FEC-75

EXPERIMENTAL

Patients receive paclitaxel IV once weekly and trastuzumab IV once weekly for 12 weeks. Beginning 7 days after the completion of paclitaxel and trastuzumab, patients receive FEC comprising fluoroucacil IV, epirubicin IV, and cyclophosphamide IV on day 1. Treatment repeats every 21 days for 4 courses. Patients also receive trastuzumab IV once weekly for an additional 12 weeks. Within 6 weeks after completion of FEC and trastuzumab, patients undergo surgery. Beginning 3-4 weeks after surgery, patients receive trastuzumab as in arm I.

Drug: CyclophosphamideDrug: Epirubicin HydrochlorideOther: Laboratory Biomarker AnalysisDrug: PaclitaxelProcedure: Therapeutic Conventional SurgeryBiological: Trastuzumab

Interventions

CyclophosphamideDRUG

Given IV

Also known as: (-)-Cyclophosphamide, 2H-1,3,2-Oxazaphosphorine, 2-[bis(2-chloroethyl)amino]tetrahydro-, 2-oxide, monohydrate, Carloxan, Ciclofosfamida, Ciclofosfamide, Cicloxal, Clafen, Claphene, CP monohydrate, CTX, CYCLO-cell, Cycloblastin, Cycloblastine, Cyclophospham, Cyclophosphamid monohydrate, Cyclophosphamidum, Cyclophosphan, Cyclophosphane, Cyclophosphanum, Cyclostin, Cyclostine, Cytophosphan, Cytophosphane, Cytoxan, Fosfaseron, Genoxal, Genuxal, Ledoxina, Mitoxan, Neosar, Revimmune, Syklofosfamid, WR- 138719