What side effects are associated with this type of intervention?

Common treatments for breast cancer, particularly those involving chemotherapy and peripheral stem cell transplantation, can lead to a range of side effects. Chemotherapy often causes nausea, vomiting, fatigue, hair loss, and an increased risk of infections due to lowered white blood cell counts. Peripheral stem cell transplantation, which allows for higher doses of chemotherapy, can exacerbate these side effects and add risks such as graft-versus-host disease, organ damage, and increased susceptibility to secondary cancers. Long-term effects may include cardiotoxicity, infertility, and cognitive impairments.

What prior FDA approvals exist?

The FDA has approved several chemotherapy drugs and combinations for the treatment of breast cancer. These include doxorubicin, cyclophosphamide, paclitaxel, and docetaxel, which are often used in various combinations to enhance efficacy. Additionally, treatments that allow higher doses of chemotherapy, such as those involving peripheral stem cell transplantation, have been explored to improve outcomes by enabling more aggressive chemotherapy regimens. These approaches aim to maximize tumor cell kill while managing the associated toxicities through stem cell support.

What other types of research exist?

Promising novel alternatives to chemotherapy and peripheral stem cell transplantation for breast cancer patients include targeted therapies (e.g., HER2 inhibitors), immunotherapy (e.g., checkpoint inhibitors), and hormone therapy for hormone receptor-positive cancers. Precision medicine and personalized treatment plans based on genetic profiling are also emerging as effective strategies.

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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

No Placebo-Only Group

Summary

This trial is testing a combination of strong cancer drugs, stem cell replacement, surgery, and radiation in patients with severe stage IIIB breast cancer. The goal is to kill cancer cells, help the body recover, remove the tumor, and eliminate any remaining cancer cells.

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.

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.

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

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Five-year Overall Survival

Three-year Relapse-free Survival

Awards & Highlights

No Placebo-Only Group

All patients enrolled in this study will receive some form of active treatment.

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

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for breast cancer, such as chemotherapy and peripheral stem cell transplantation, work by targeting the division and growth of tumor cells. Chemotherapy uses drugs to stop tumor cells from dividing, leading to their death or halted growth. Peripheral stem cell transplantation allows for higher doses of chemotherapy by replenishing the body's blood-forming cells, which are damaged by the treatment. This approach aims to enhance the effectiveness of chemotherapy while reducing its severe side effects, offering a more aggressive treatment option for breast cancer patients.

Carboplatin in the Treatment of Small Cell Lung Cancer.