Chemotherapy + Stem Cell Transplant for Breast Cancer

Overseen by George Somlo, MD

Age: 18 - 65

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: City of Hope Medical Center

No Placebo Group

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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.

Research Team

George Somlo, MD

Principal Investigator

City of Hope Medical Center

Eligibility Criteria

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.

Inclusion Criteria

Your liver enzymes (SGOT or SGPT) should not be more than 1.5 times the normal limit.

Your lung function test shows that your lungs are working at least 60% as well as they should be.

You do not have hepatitis B or HIV.

Exclusion Criteria

You have had a type of disease that affects your lymphatic system.

You have had cancer that is currently active.

You had cancer in the last 5 years, except for certain types of skin cancer.

Treatment Details

Interventions

• Bone Marrow Ablation with Stem Cell Support (Procedure)
• Cisplatin (Platinum-containing Compound)
• Conventional Surgery (Surgery)
• Cyclophosphamide (Alkylating agents)
• Doxorubicin Hydrochloride (Anthracycline)
• Filgrastim (Hematopoietic Growth Factor)
• Melphalan (Alkylating agents)
• Paclitaxel (Taxane)
• Peripheral Blood Stem Cell Transplantation (Stem Cell Transplantation)

Trial Overview 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.

Participant Groups

Group I: More than 1 cycle of neoadjuvant chemotherapy Experimental Treatment 9 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 chemotherapy Experimental Treatment 11 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.

Cisplatin is already approved in Canada, Japan for the following indications:

Approved in Canada as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Approved in Japan as Platinol for:

• Testicular cancer
• Ovarian cancer
• Cervical cancer
• Bladder cancer
• Head and neck cancer
• Esophageal cancer
• Lung cancer
• Mesothelioma
• Brain tumors
• Neuroblastoma

Who Is Running the Clinical Trial?

City of Hope Medical Center

Lead Sponsor

Trials

614

Recruited

1,924,000+

Robert Stone

City of Hope Medical Center

Chief Executive Officer since 2014

Juris Doctorate from the University of Chicago, Bachelor's degree in Political Science from the University of Redlands

Sumanta (Monty) Pal

City of Hope Medical Center

Chief Medical Officer since 2023

MD

National Cancer Institute (NCI)

Collaborator

Trials

14,080

Recruited

41,180,000+

Dr. Douglas R. Lowy

National Cancer Institute (NCI)

Chief Executive Officer since 2023

MD from New York University School of Medicine

Dr. Monica Bertagnolli

National Cancer Institute (NCI)

Chief Medical Officer since 2022

MD from Harvard Medical School