NCT00118053|TerminatedPhase 2Results

Study Stopped

slow accrual

Trastuzumab, Docetaxel, and Carboplatin in Treating Women With Stage II, Stage III, or Inflammatory Breast Cancer

A Phase II Trial of Taxotere, Carboplatin and Herceptin in Locally Advanced or Inflammatory Breast Cancer

University of Medicine and Dentistry of New Jersey ClinicalTrials.gov

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5 other identifiers

040412;CDR0000433511P30CA072720CINJ-0404120220045191CINJ-NJ1104

Study Type

interventional

Target

Locations

1 country

Sites

Timeline

RegisteredJul 2005

StartedApr 2005

CompletionDec 2008

Brief Summary

RATIONALE: 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. Drugs used in chemotherapy, such as docetaxel and carboplatin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving trastuzumab together with docetaxel and carboplatin may kill more tumor cells. PURPOSE: This phase II trial is studying how well giving trastuzumab together with docetaxel and carboplatin works in treating women with stage II, stage III, or inflammatory breast cancer.

Trial Health

Monitor

Trial Health Score

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

Enrollment

participants targeted

Target at below P25 for phase_2 breast-cancer

Timeline

Completed

Started Apr 2005

Geographic Reach

1 country

9 active sites

Status

terminated

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

3.7 years study duration

Study Start

First participant enrolled

April 1, 2005

Completed

3 months until next milestone

First Submitted

Initial submission to the registry

July 8, 2005

Completed

3 days until next milestone

First Posted

Study publicly available on registry

July 11, 2005

Completed

3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2008

Completed

Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2008

Completed

5 years until next milestone

Results Posted

Study results publicly available

November 20, 2013

Completed

Last Updated

November 20, 2013

Status Verified

September 1, 2013

Enrollment Period

3.7 years

First QC Date

July 8, 2005

Results QC Date

September 17, 2013

Last Update Submit

September 17, 2013

Conditions

Breast Cancer

Keywords

inflammatory breast cancerstage II breast cancerstage IIIA breast cancerstage IIIB breast cancerstage IIIC breast cancer

Outcome Measures

Primary Outcomes (1)

Antitumor Activity as Measured by Response Rate
5 years

Secondary Outcomes (3)

Pathological Complete Response
5 years
Disease-free Survival
10 years
Pathologic and Molecular Markers for Predicting Efficacy
5 years

Study Arms (1)

Docetaxel, Carboplatin and Trastuzumab

EXPERIMENTAL

A total of six cycles of TCH \[(Taxotere® (75 mg/m2) + Carboplatin (AUC = 6) + Herceptin® (2 mg/kg weekly after a 4 mg/kg load on Day 1)\] will be administered every 3 weeks.Three weeks after receiving the sixth cycle of TCH, all patients will be restaged. * Those determined to have localized and operable disease (as determined by surgical consultation) will undergo a modified radical mastectomy or lumpectomy and axillary node dissection. After recovery from surgery, the patients will receive whole breast or chest wall irradiation (as determined by radiologist) with concurrent Herceptin® (6 mg/kg). Following radiation, patients will continue Herceptin® (6 mg/kg) every 3 weeks until they have been on study for a total of 52 weeks. * If patients are staged and are negative they will continue Herceptin® (6 mg/kg)every 3 weeks until they have been on study for a total of 52 weeks.

Biological: herceptinDrug: carboplatinDrug: docetaxelProcedure: conventional surgeryProcedure: radiation therapy