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Platinum-containing Compound

Chemotherapy + Stem Cell Transplant for Breast Cancer

Phase 2

Waitlist Available

Led By George Somlo, MD

Research Sponsored by City of Hope Medical Center

Eligibility Criteria Checklist

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

Must have

Be between 18 and 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up from date of mastectomy until date of death, 5 years post mastectomy.

Awards & highlights

Study Summary

This trial is studying chemotherapy and stem cell transplantation for stage IIIB breast cancer.

Who is the study for?

This trial is for individuals under 60 with stage IIIB breast cancer showing skin invasion or inflammation symptoms. They must have good heart and lung function, no severe psychosocial issues, and cannot be pregnant. Those with a history of other cancers in the last 5 years (except certain skin or cervical cancers) can't join.Check my eligibility

What is being tested?

The study tests high-dose chemotherapy combined with stem cell transplantation to treat advanced breast cancer. It aims to see if this approach is more effective at killing tumor cells than standard treatments.See study design

What are the potential side effects?

Potential side effects include damage to organs from high-dose chemo like heart, lungs, liver; risk of infection due to low blood counts; nausea; hair loss; mouth sores; and infertility related to stem cell transplant.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ from date of mastectomy until date of death, 5 years post mastectomy.

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~from date of mastectomy until date of death, 5 years post mastectomy.

This trial's timeline: 3 weeks for screening, Varies for treatment, and from date of mastectomy until date of death, 5 years post mastectomy. for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Five-year Overall Survival

Three-year Relapse-free Survival

Trial Design

2Treatment groups

Experimental Treatment

Group I: More than 1 cycle of neoadjuvant chemotherapyExperimental Treatment9 Interventions

Patients receive chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.

Group II: 1 cycle of neoadjuvant chemotherapyExperimental Treatment11 Interventions

Patients receive chemotherapy, surgical removal of the cancer followed by additional chemotherapy, followed by two treatment cycles of very high-dose chemotherapy, return of bone marrow derived cells, followed by radiation therapy and if indicated five years of tamoxifen treatment.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

conventional surgery

1994

Completed Phase 3

~13900

peripheral blood stem cell transplantation

1997

Completed Phase 3

~4330

filgrastim

1997

Completed Phase 3

~7260

cisplatin

1997

Completed Phase 3

~3290

cyclophosphamide

1994

Completed Phase 3

~8140

doxorubicin hydrochloride

1994

Completed Phase 3

~9590

melphalan

1994

Completed Phase 3

~3530

mesna

1992

Completed Phase 3

~1420

paclitaxel

1996

Completed Phase 3

~4310

tamoxifen citrate

2000

Completed Phase 3

~17870

bone marrow ablation with stem cell support

2005

Completed Phase 3

~1770

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

City of Hope Medical CenterLead Sponsor

565 Previous Clinical Trials

1,921,419 Total Patients Enrolled

42 Trials studying Breast Cancer

6,608 Patients Enrolled for Breast Cancer

National Cancer Institute (NCI)NIH

13,657 Previous Clinical Trials

40,933,626 Total Patients Enrolled

939 Trials studying Breast Cancer

1,543,319 Patients Enrolled for Breast Cancer

George Somlo, MDPrincipal InvestigatorCity of Hope Medical Center

10 Previous Clinical Trials

508 Total Patients Enrolled

6 Trials studying Breast Cancer

385 Patients Enrolled for Breast Cancer

Media Library

Cisplatin (Platinum-containing Compound) Clinical Trial Eligibility Overview. Trial Name: NCT00003042 — Phase 2

Breast Cancer Research Study Groups: More than 1 cycle of neoadjuvant chemotherapy, 1 cycle of neoadjuvant chemotherapy

Breast Cancer Clinical Trial 2023: Cisplatin Highlights & Side Effects. Trial Name: NCT00003042 — Phase 2

Cisplatin (Platinum-containing Compound) 2023 Treatment Timeline for Medical Study. Trial Name: NCT00003042 — Phase 2

Frequently Asked Questions

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

May I enlist in this clinical investigation?

"This clinical trial has a maximum capacity of 41 breast cancer patients aged between 18 and 60. In order to be admitted, individuals must fulfill the following criteria: SGOT/SGPT levels below 1.5 times the upper limit of normal; histologically diagnosed stage IIIB breast cancer with skin inflammation symptoms; diagnosis within 6 months prior; Karnofsky score ranging from 80-100%; absolute neutrophil count at least 1500 per mm3; platelet count at least 100000 per mm3, bilirubin concentration lower than 1.5 mg/dL and creatinine amount less than 1.2 mg/dL."

Answered by AI

Are there any known risks associated with filgrastim treatments?

"Our Power team has rated filgrastim's safety as a 2. This is due to the medication being in Phase 2 of clinical trials, and thus having limited evidence for its efficacy but some information proving it safe to use."

Answered by AI

How many participants has this clinical trial recruited thus far?

"Unfortunately, this study is not presently seeking new participants. It was first uploaded to clinicaltrials.gov on May 30th 1997 and last modified on February 17th 2022. For those interested in other trials, 2600 studies are currently recruiting patients with breast cancer and 2319 requiring filgrastim enrolment."

Answered by AI

Is geriatric participation accepted in this clinical research?

"To be considered for this medical trial, candidates must fall between 18 and 60 years of age. Conversely, there are 472 trials aimed at minors and 4541 specifically oriented towards older individuals."

Answered by AI

What does filgrastim commonly treat?

"Filgrastim is commonly employed to address Kaposi's Sarcoma, caused by the AIDS virus. It also has applications in various other cancers such as leukemia, metastatic bladder cancer, and locally advanced non-small cell lung cancer."

Answered by AI

Are there any opportunities to participate in this trial at present?

"Clinicaltrials.gov verifies that this particular trial, which was originally posted on May 30th 1997 and updated most recently in February 17th 2022, is not presently open for enrollment. However, there are 4,919 other clinical studies actively looking for patients to join them today."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer

1997. "Chemotherapy and Stem Cell Transplantation in Treating Patients With Stage IIIB Breast Cancer". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT00003042.

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