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Chemotherapy

Paclitaxel + Chemotherapy for 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

Histologically diagnosed adenocarcinoma of the breast of the following stages: Stage II/IIIA disease with 4 or more involved axillary lymph nodes, Stage IIIB Inflammatory

No history of second malignancy within 5 years except: Nonmelanomatous skin cancer, In situ carcinoma of the cervix

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 combination chemotherapy followed by a peripheral stem cell transplant works in treating women with breast cancer.

Who is the study for?

This trial is for women aged 18-65 with high-risk breast cancer who have had at least three rounds of initial therapy without disease progression. They must have a good heart function, no severe cardiac issues, normal liver and kidney functions, and not be HIV positive or pregnant. Previous breast cancer patients can join if they meet other criteria.Check my eligibility

What is being tested?

The study is testing the addition of Paclitaxel to high-dose chemotherapy followed by peripheral stem cell transplantation in women with high-risk breast cancer. The goal is to see if this combination helps prevent the cancer from coming back.See study design

What are the potential side effects?

Possible side effects include those typical of chemotherapy such as nausea, hair loss, fatigue, increased risk of infection due to low blood counts, and potential damage to nerves (neuropathy) caused by Paclitaxel.

Eligibility Criteria

Inclusion Criteria

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

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My breast cancer is at Stage II or IIIA with 4+ lymph nodes involved, or it's inflammatory Stage IIIB.

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I haven't had cancer in the last 5 years, except for skin cancer or cervical carcinoma in situ.

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My lung function test shows at least 60% of normal.

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My kidneys are functioning well.

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

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My condition has not worsened during initial treatment.

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I am between 18 and 65 years old.

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I am mostly able to care for myself and carry out daily activities.

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My bilirubin level is 2.0 mg/dL or lower.

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I am a woman.

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 / 10Eligibility criteria met

Find a Location

Who is running the clinical trial?

St. Louis UniversityLead Sponsor

194 Previous Clinical Trials

43,625 Total Patients Enrolled

1 Trials studying Breast Cancer

50 Patients Enrolled for Breast Cancer

Paul J. Petruska, MDStudy ChairSt. Louis University

1 Previous Clinical Trials

50 Total Patients Enrolled

1 Trials studying Breast Cancer

50 Patients Enrolled for Breast Cancer

Media Library

High-Dose Combination Chemotherapy (Chemotherapy) Clinical Trial Eligibility Overview. Trial Name: NCT00002627 — Phase 1 & 2

Breast Cancer Clinical Trial 2023: High-Dose Combination Chemotherapy Highlights & Side Effects. Trial Name: NCT00002627 — Phase 1 & 2

High-Dose Combination Chemotherapy (Chemotherapy) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00002627 — Phase 1 & 2

Frequently Asked Questions

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

What are the eligibility criteria for those wishing to partake in this trial?

"This clinical trial, open to women aged 18-65 with breast cancer, is recruiting 30 participants. The primary criteria for eligibility includes: histologically diagnosed adenocarcinoma of the breast; Karnofsky performance status between 70%-100%; Bilirubin no greater than 2.0 mg/dL; Creatinine clearance at least 60 mL/min; Left ventricular ejection fraction of 50% or more by MUGA scan and DLCO at least 60% of predicted values. Furthermore, applicants must have completed three courses of induction treatment without disease progression prior to enrolment in this study."

Answered by AI

Does this study provide opportunities for those younger than 60 years of age?

"This medical study is looking for participants who have reached the legal age of consent, but are below 65 years old."

Answered by AI

Are there any vacancies available in this research project?

"This study has not been actively looking for participants since 2014, as indicated on clinicaltrials.gov. Although the trial was initially posted in 1994, none of those spots are still available today; however, there are currently 2600 other medical trials that have open slots to fill at this time."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

1994. "Addition of Paclitaxel to High-Dose Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00002627.

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