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Anti-microtubule agent

Paclitaxel +/- Carboplatin for Breast Cancer

Phase 3
Waitlist Available
Research Sponsored by Theradex
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Patients with disease progression after prior response to hormonal therapy are eligible
HER-2/neu negative (0, 1+, or 2+ by immunohistochemistry or fluorescent in situ hybridization) OR status unknown
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights

Study Summary

This trial is looking at whether paclitaxel with or without carboplatin is more effective in treating stage IV breast cancer.

Who is the study for?
This trial is for women over 18 with stage IV breast cancer who haven't had chemotherapy for metastatic disease, trastuzumab, or certain other treatments in the last 6 months. They must have a measurable tumor and no serious medical conditions that would interfere with participation. Women with bone-only disease or certain heart conditions can't join.Check my eligibility
What is being tested?
The study is testing whether paclitaxel alone or combined with carboplatin is more effective in treating stage IV breast cancer. Participants will be randomly assigned to one of these two treatment groups to compare outcomes.See study design
What are the potential side effects?
Paclitaxel may cause side effects like allergic reactions, blood disorders, hair loss, muscle and joint pain. Carboplatin can add risks such as kidney damage, hearing problems, and more severe blood-related issues.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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My condition worsened after initially responding to hormone therapy.
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My cancer is not HER2 positive or its HER2 status is unknown.
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My breast cancer diagnosis was confirmed through lab tests.
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My liver tests are within the required range.
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My kidney function is within the required range and my calcium levels are not too high.
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My heart is generally healthy with no recent major issues.
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I do not have any serious infections.
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I do not have severe numbness or pain in my hands or feet.
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I am able to get out of my bed or chair and move around.
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I am female.
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My condition is at stage IV, indicating it has spread to other parts of my body.
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I am 18 years old or older.

Timeline

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

Find a Location

Who is running the clinical trial?

TheradexLead Sponsor
33 Previous Clinical Trials
1,532 Total Patients Enrolled
1 Trials studying Breast Cancer
80 Patients Enrolled for Breast Cancer
Edith A. Perez, MDStudy ChairMayo Clinic
18 Previous Clinical Trials
10,227 Total Patients Enrolled
17 Trials studying Breast Cancer
10,121 Patients Enrolled for Breast Cancer

Media Library

Paclitaxel (Anti-microtubule agent) Clinical Trial Eligibility Overview. Trial Name: NCT00025688 — Phase 3
Breast Cancer Research Study Groups:
Breast Cancer Clinical Trial 2023: Paclitaxel Highlights & Side Effects. Trial Name: NCT00025688 — Phase 3
Paclitaxel (Anti-microtubule agent) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00025688 — Phase 3

Frequently Asked Questions

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

On how many continents is this research being conducted?

"Currently, this trial is being conducted at 25 sites across the country. If you are considering participating in this study, please choose the location nearest to you from the list of locations below to minimize travel time and expenses."

Answered by AI

Are people able to sign up for this clinical trial at this time?

"Unfortunately, this particular trial is not looking for new participants at the moment. According to the clinicaltrials.gov website, this study was first posted on 01/01/2001 and was last edited on 07/23/2008. Although this specific research project isn't recruiting right now, there are 2,695 other trials that are currently accepting patients."

Answered by AI

Does this medication have the FDA's blessing?

"There is some clinical data supporting the efficacy of this treatment and it has received multiple rounds of safety testing, so we have given it a score of 3."

Answered by AI
~14 spots leftby Mar 2025