Carboplatin and Gemcitabine in Treating Patients With Locally Advanced or Metastatic Breast Cancer

Phase 2

Terminated

• Conditions: Breast Cancer
• Interventions: Drug: Carboplatin; Drug: Gemcitabine Hydrochloride

• Registration Number: NCT00470249
• Lead Sponsor: University of Southampton

Brief Summary

RATIONALE: Drugs used in chemotherapy, such as carboplatin and gemcitabine, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving carboplatin together with gemcitabine works in treating patients with locally advanced or metastatic breast cancer.

Detailed Description

OBJECTIVES:

Primary

* Determine the overall response rate in patients with anthracycline- and taxane-resistant locally advanced or metastatic breast cancer treated with dose-dense carboplatin and gemcitabine hydrochloride.

Secondary

* Determine the overall toxicity of this regimen in these patients.

* Determine the overall survival of patients treated with this regimen.

* Determine the time to disease progression in patients treated with this regimen.

* Determine the duration of response in patients treated with this regimen.

* Determine the time to treatment failure in patients treated with this regimen.

OUTLINE: This is a nonrandomized, open-label study.

Patients receive carboplatin IV over 30 minutes on day 1 and gemcitabine hydrochloride IV over 150 minutes on day 2. Treatment repeats every 14 days for up to 9 courses in the absence of disease progression or unacceptable toxicity.

After completion of study therapy, patients are followed periodically for 2 years.

PROJECTED ACCRUAL: A total of 35 patients will be accrued for this study.

Study Timeline

• Study Start: 2006-07-15
• Study First Submitted: 2007-05-03
• Study First Submitted QC: 2007-05-03
• Study First Posted: 2007-05-07
• Primary Completion: 2008-11-03
• Study Completion: 2008-11-03
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-29
• Last Update Posted: 2021-02-01

Recruitment & Eligibility

• Status: TERMINATED
• Sex: All
• Target Recruitment: 5

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Patients with (HER-2)-negative and anthracycline- and taxane-resistant	Gemcitabine Hydrochloride	Patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant
Patients with (HER-2)-negative and anthracycline- and taxane-resistant	Carboplatin	Patients with human epidermal growth factor 2 (HER-2)-negative locally advanced or metastatic breast cancer that was anthracycline- and taxane-resistant

Primary Outcome Measures

Name	Time	Method
Overall response rate (complete or partial response)	8 months	Assess the Overall response rate (complete or partial response)

Secondary Outcome Measures

Name	Time	Method
Time to disease progression	8 months	Assess Time to disease progression
Overall toxicity as assessed by NCI CTCAE v3.0	8 months	Summary Overall toxicity as assessed by NCI CTCAE v3.0
Overall survival	8 months	Assess Overall survival
Time to treatment failure	8 months	Assess Time to treatment failure
Duration of response	8 months	Assess Duration of response

Trial Locations

Locations (3)

Royal Bournemouth Hospital; 🇬🇧 Bournemouth, England, United Kingdom

Portsmouth Oncology Centre at Saint Mary's Hospital; 🇬🇧 Portsmouth, England, United Kingdom

Southampton General Hospital; 🇬🇧 Southampton, England, United Kingdom