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

NCT00003042 | Completed Phase 2 Results

• 5 other identifiers: 96139P30CA033572CHNMC-96139NCI-G97-1288CDR0000065672
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining chemotherapy with peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. PURPOSE: This phase II trial is studying how well chemotherapy and stem cell transplantation work in treating patients with stage IIIB breast cancer.

Conditions

Breast Cancer

Keywords

stage IIIB breast cancer; inflammatory breast cancer

Outcome Measures

Primary Outcomes (2)

• Three-year Relapse-free Survival

  Estimated using the product-limit method of Kaplan and Meier. Relapse defined as appearance of any new lesions during or after protocol treatment.

  From date of mastectomy until date of relapse or death from any cause, 3 years post mastectomy.

• Five-year Overall Survival

  Estimated using the product-limit method of Kaplan and Meier. Endpoint is defined as death due to any cause.

  From date of mastectomy until date of death, 5 years post mastectomy.

Study Arms (2)

1 cycle of neoadjuvant chemotherapy

EXPERIMENTAL

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.

Biological: filgrastim; Drug: cisplatin; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: melphalan; Drug: mesna; Drug: paclitaxel; Drug: tamoxifen citrate; Procedure: bone marrow ablation with stem cell support; Procedure: conventional surgery; Procedure: peripheral blood stem cell transplantation

More than 1 cycle of neoadjuvant chemotherapy

EXPERIMENTAL

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.

Biological: filgrastim; Drug: cisplatin; Drug: doxorubicin hydrochloride; Drug: melphalan; Drug: mesna; Drug: paclitaxel; Drug: tamoxifen citrate; Procedure: bone marrow ablation with stem cell support; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

cisplatin DRUG

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

cyclophosphamide DRUG

1 cycle of neoadjuvant chemotherapy

doxorubicin hydrochloride DRUG

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

melphalan DRUG

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

mesna DRUG

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

paclitaxel DRUG

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

tamoxifen citrate DRUG

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

bone marrow ablation with stem cell support PROCEDURE

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

conventional surgery PROCEDURE

1 cycle of neoadjuvant chemotherapy

peripheral blood stem cell transplantation PROCEDURE

1 cycle of neoadjuvant chemotherapy; More than 1 cycle of neoadjuvant chemotherapy

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically proven stage IIIB breast cancer with dermal/epidermal invasion or clinical features of inflammation, erythema, pain or hypersensitivity, edema, or thickening of the skin * Diagnosis within the past 6 months PATIENT CHARACTERISTICS: Age: * 60 and under Performance status: * Karnofsky 80-100% Life expectancy: * Not specified Hematopoietic: * Absolute neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin less than 1.5 mg/dL * SGOT or SGPT no greater than 1.5 times the upper limit of normal Renal: * Creatinine less than 1.2 mg/dL * Creatinine clearance at least 80 mL/min * No history of hemorrhagic cystitis Cardiovascular: * Left ventricular fraction at least 55% on MUGA scan * No previous valvular heart disease or arrhythmia Pulmonary: * FEV\_1 at least 60% predicted * Room air pO\_2 greater than 85 mmHg * Room air pCO\_2 no greater than 43 mmHg * DLCO at least 60% of the lower limit of predicted value Other: * No history of malignant disease in the past 5 years, except for squamous or basal cell skin cancer and stage I or in situ cervical cancer * No organic CNS dysfunction * Not pregnant * No known and potentially disabling psychosocial history * Not positive for hepatitis B or HIV PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * Stratum 1: * No more than one cycle of chemotherapy * Stratum 2: * No greater than 225 mg/m\^2 doxorubicin and no greater than 250 mg/m\^2 paclitaxel during previous chemotherapy Endocrine therapy: * Not specified Radiotherapy: * No prior radiation to the left chest wall Surgery: * Modified radical mastectomy allowed

Contact the study team to discuss eligibility requirements. They can help determine if this study is right for you.

Sponsors & Collaborators

• City of Hope Medical Center: lead
• National Cancer Institute (NCI): collaborator

Study Sites (1)

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast Neoplasms; Inflammatory Breast Neoplasms

Interventions

Filgrastim; Cisplatin; Cyclophosphamide; Doxorubicin; Melphalan; Mesna; Paclitaxel; Tamoxifen; Peripheral Blood Stem Cell Transplantation

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Breast Diseases; Skin Diseases; Skin and Connective Tissue Diseases

Intervention Hierarchy (Ancestors)

Granulocyte Colony-Stimulating Factor; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Hematopoietic Cell Growth Factors; Cytokines; Intercellular Signaling Peptides and Proteins; Peptides; Amino Acids, Peptides, and Proteins; Proteins; Biological Factors; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Organic Chemicals; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Phenylalanine; Amino Acids, Aromatic; Amino Acids, Cyclic; Amino Acids; Alkanesulfonates; Alkanesulfonic Acids; Alkanes; Hydrocarbons, Acyclic; Sulfhydryl Compounds; Sulfur Compounds; Sulfonic Acids; Sulfur Acids; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Stilbenes; Benzylidene Compounds; Benzene Derivatives; Hematopoietic Stem Cell Transplantation; Stem Cell Transplantation; Cell Transplantation; Cell- and Tissue-Based Therapy; Biological Therapy; Therapeutics; Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Paul Frankel, Ph.D.
• Organization: City of Hope

pfrankel@coh.org

626-218-5265

Study Officials

• George Somlo, MD

  City of Hope Medical Center

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: January 27, 2003
• Study Start: May 30, 1997
• Primary Completion: February 9, 2010
• Study Completion: November 6, 2025
• Last Updated: February 20, 2026
• Results First Posted: April 8, 2021

Record last verified: 2026-02

Locations

US (1)