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Anti-metabolites

Chemotherapy With/Without Thermotherapy for Breast Cancer

Phase 2

Waitlist Available

Research Sponsored by Imunon

Eligibility Criteria Checklist

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

Must have

No inflammatory breast cancer

No multicentric disease

Timeline

Screening 3 weeks

Treatment Varies

Follow Up up to 5 years

Awards & highlights

Study Summary

This trial is studying how well giving combination chemotherapy with or without microwave thermotherapy before surgery works in treating patients with locally advanced breast cancer.

Who is the study for?

This trial is for women over 18 with locally advanced breast cancer who are candidates for mastectomy and chemotherapy. They must have a life expectancy of at least 6 months, good organ function, no recent participation in other trials, not be pregnant or nursing, and agree to use two contraception methods. Exclusions include heart disease, bleeding disorders, liver disease, kidney issues, mental conditions affecting study participation.Check my eligibility

What is being tested?

The trial is testing if adding microwave thermotherapy to standard combination chemotherapy before surgery can better shrink tumors in women with locally advanced breast cancer. Participants will be randomly assigned to receive either just chemotherapy or both treatments.See study design

What are the potential side effects?

Chemotherapy may cause nausea, hair loss, fatigue, increased risk of infection and anemia. Microwave thermotherapy could potentially lead to burns or heat-related damage to skin or surrounding tissues.

Eligibility Criteria

Inclusion Criteria

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

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I do not have inflammatory breast cancer.

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My cancer is located in one area only.

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I am 18 years old or older.

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I have never had a collagen vascular disease.

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I can lie on my stomach and handle pressure on my breast.

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I am recommended to have a mastectomy and chemotherapy before surgery.

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My breast cancer is confirmed and has spread locally but not to distant parts.

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My cancer is at stage III.

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My breast tumor can be measured by an ultrasound and physical exam.

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My cancer has not spread to my chest muscle or skin.

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My cancer has not spread to the nipple.

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

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I have not had breast cancer in both breasts.

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I do not have serious heart problems.

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I have no health conditions that prevent me from receiving chemotherapy.

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I am female.

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 / 16Eligibility criteria met

Find a Location

Who is running the clinical trial?

ImunonLead Sponsor

15 Previous Clinical Trials

1,588 Total Patients Enrolled

3 Trials studying Breast Cancer

17 Patients Enrolled for Breast Cancer

CelsionLead Sponsor

13 Previous Clinical Trials

1,464 Total Patients Enrolled

3 Trials studying Breast Cancer

17 Patients Enrolled for Breast Cancer

William E. Gannon, MDStudy ChairImunon

1 Previous Clinical Trials

1 Trials studying Breast Cancer

Media Library

Chemotherapy (Anti-metabolites) Clinical Trial Eligibility Overview. Trial Name: NCT00036985 — Phase 2

Breast Cancer Clinical Trial 2023: Chemotherapy Highlights & Side Effects. Trial Name: NCT00036985 — Phase 2

Chemotherapy (Anti-metabolites) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00036985 — Phase 2

Frequently Asked Questions

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

What potential harms could patients face while undergoing this treatment?

"Our assessment of the safety profile for this treatment is 2 on a scale from 1 to 3. This rating was determined as it is yet to be established whether or not efficacy has been adequately demonstrated in Phase 2 trials."

Answered by AI

Is this study recruiting participants at the present time?

"Per the information hosted on clinicaltrials.gov, this experiment is inactive and not presently seeking patients; it was initially published in August 2001 and last updated December 2013. Fortunately for those looking to participate in medical trials, 2600 other studies are actively recruiting at the moment."

Answered by AI

How many medical centers are currently participating in this clinical trial?

"Seven medical centres have committed to recruiting for this trial, including St. Joseph Hospital Regional Cancer Center in Orange, Breast Care Specialists P.C. based in Norfolk and the Oklahoma University Medical Centre at University of Oklahoma Health Sciences Center located in Oklahoma City, as well other outposts."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer

2001. "Combination Chemotherapy With or Without Microwave Thermotherapy Before Surgery in Treating Women With Locally Advanced Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00036985.

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