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Platinum-based compound

Paclitaxel + Chemotherapy for Metastatic Breast Cancer

Phase 1 & 2

Waitlist Available

Research Sponsored by St. Louis University

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Cardiovascular: Left ventricular ejection fraction greater than 50% on MUGA or echocardiogram, No abnormal cardiac conduction on EKG (i.e., No second- or third-degree heart block, No bundle-branch block, No arrhythmia except: Supraventricular sinus tachycardia, Occasional premature atrial or ventricular contractions)

Renal: Creatinine clearance greater than 60 mL/min

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well giving paclitaxel together with high-dose chemotherapy works in treating women with breast cancer that has spread to other parts of the body.

Who is the study for?

This trial is for women with metastatic breast cancer who haven't had treatment or only had adjuvant chemotherapy. They must be aged 18-65, have a good performance status (ECOG 0-2), no severe peripheral neuropathy, HIV, recent cancers (except certain skin/cervical cancers), active brain metastases, or be pregnant/nursing. Their heart and kidney functions should meet specific criteria.Check my eligibility

What is being tested?

The study tests adding paclitaxel to high-dose chemo with cyclophosphamide and carboplatin followed by stem cell transplantation in treating metastatic breast cancer. It's a Phase I/II trial aiming to see if this combination can more effectively kill tumor cells.See study design

What are the potential side effects?

Potential side effects include those common to chemotherapy such as nausea, hair loss, fatigue, risk of infection due to low blood counts; nerve damage from paclitaxel; organ dysfunction risks from high-dose chemo; and complications related to stem cell transplant.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My heart functions well and I don't have serious heart rhythm problems.

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My kidneys are functioning well.

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I've had a partial or complete response to my initial chemotherapy.

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I am between 18 and 65 years old.

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I am either before or after menopause.

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I have either not been treated or only received initial chemotherapy.

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My breast cancer is at stage IV and confirmed by tissue analysis.

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I am a woman.

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I am able to get out of my bed or chair and move around.

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My lung function test shows normal breathing ability.

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My bilirubin level is 2.0 mg/dL or lower.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ up to 5 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~up to 5 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

0 / 11Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor

194 Previous Clinical Trials

43,605 Total Patients Enrolled

1 Trials studying Breast Cancer

30 Patients Enrolled for Breast Cancer

Paul J. Petruska, MDStudy ChairSt. Louis University

1 Previous Clinical Trials

30 Total Patients Enrolled

1 Trials studying Breast Cancer

30 Patients Enrolled for Breast Cancer

Media Library

Carboplatin (Platinum-based compound) Clinical Trial Eligibility Overview. Trial Name: NCT00002628 — Phase 1 & 2

Breast Cancer Clinical Trial 2023: Carboplatin Highlights & Side Effects. Trial Name: NCT00002628 — Phase 1 & 2

Carboplatin (Platinum-based compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00002628 — Phase 1 & 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any unfilled slots available in this research protocol?

"The information hosted on clinicaltrials.gov shows that this medical study is no longer actively recruiting, as the last update was posted in January 2014. Nevertheless, there are still 2596 trials currently seeking participants at this time."

Answered by AI

Who is most suitable for inclusion in this medical experiment?

"To be eligible for this trial, applicants must have been diagnosed with breast cancer and fit within the age bracket of 18 to 65. A total of 50 patients will be accepted upon meeting these criteria."

Answered by AI

Is participation in this trial limited to adults above a certain age cutoff?

"Participants must be between 18 and 65 years old to qualify for this trial. Conversely, there are 74 trials available for minors and 2501 specifically designed for patients aged over 65."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer

1994. "Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Women With Metastatic Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00002628.

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