Combination Chemotherapy in Treating Patients With High-Risk Breast Cancer

NCT00004092 | Completed Phase 2 Results

• 7 other identifiers: 98096U01CA063265P30CA033572CHNMC-IRB-98096CHNMC-PHII-18NCI-H99-0038CDR0000067305
• Study Type: interventional
• Target: 72
• Locations: 1 country
• Sites: 2

Brief Summary

RATIONALE: Drugs used in chemotherapy use different ways to stop tumor cells from dividing so they stop growing or die. Combining more than one drug may kill more tumor cells. PURPOSE: This randomized phase II trial is studying two different regimens of combination chemotherapy and comparing them to see how well they work in treating patients with high-risk primary stage II or stage III breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer; stage IIIB breast cancer

Outcome Measures

Primary Outcomes (1)

• Five-Year Relapse-free Survival

  RFS events included death or disease recurrence. Patients who did not experience disease recurrence or death were censored at the date of last follow-up. Survival rates were estimates using the Kaplan-Meier method.

  Five years

Secondary Outcomes (1)

• Five-Year Overall Survival

  Five Years

Study Arms (2)

Arm I (ACT) (closed to accrual as of 4/6/2006)

EXPERIMENTAL

Patients receive doxorubicin IV over 24 hours on days -9 to -6, cyclophosphamide IV over 2 hours on day -5, and paclitaxel IV over 24 hours on day -2. PBSC are reinfused on days -2 and 0. G-CSF is administered beginning on day 0 and continuing until blood counts recover.

Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Procedure: peripheral blood stem cell transplantation

Arm II (STAMP V)

ACTIVE COMPARATOR

Patients receive cyclophosphamide IV, carboplatin IV, and thiotepa IV over 24 hours on days -7 to -4. PBSC are reinfused and G-CSF is administered as in arm I.

Biological: filgrastim; Drug: carboplatin; Drug: cyclophosphamide; Drug: thiotepa; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

Given IV or subcutaneously

Arm I (ACT) (closed to accrual as of 4/6/2006); Arm II (STAMP V)

carboplatin DRUG

Given IV

Arm II (STAMP V)

cyclophosphamide DRUG

Given IV

Arm I (ACT) (closed to accrual as of 4/6/2006); Arm II (STAMP V)

doxorubicin hydrochloride DRUG

Given IV

Arm I (ACT) (closed to accrual as of 4/6/2006)

paclitaxel DRUG

Given IV

Arm I (ACT) (closed to accrual as of 4/6/2006)

thiotepa DRUG

Given IV

Arm II (STAMP V)

peripheral blood stem cell transplantation PROCEDURE

Patients receive autologous peripheral blood stem cells

Arm I (ACT) (closed to accrual as of 4/6/2006); Arm II (STAMP V)

Eligibility Criteria

• Age: Up to 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

DISEASE CHARACTERISTICS: * Histologically proven high-risk primary breast cancer with less than 60% chance of progression-free survival of 3 years from diagnosis * Stage II with at least 10 positive axillary nodes OR * Stage IIIA or IIIB * No histologically proven bone marrow metastasis * No CNS metastasis * Hormone receptor status: * Hormone receptor status known PATIENT CHARACTERISTICS: Age: * Physiological age 60 or under Menopausal status: * Not specified Performance status: * Karnofsky 80-100% Life expectancy: * See Disease Characteristics Hematopoietic: * Neutrophil count at least 1,500/mm\^3 * Platelet count at least 100,000/mm\^3 Hepatic: * Bilirubin no greater than 1.5 mg/dL * SGOT or SGPT no greater than 2 times upper limit of normal * Hepatitis B antigen negative Renal: * Creatinine no greater than 1.2 mg/dL * Creatinine clearance at least 70 mL/min * No prior hemorrhagic cystitis Cardiovascular: * Ejection fraction at least 55% by MUGA * No prior significant valvular heart disease or arrhythmia Pulmonary: * FEV\_1 at least 60% of predicted * pO\_2 at least 85 mm Hg on room air * pCO\_2 at least 43 mm Hg on room air * DLCO at least 60% lower limit of predicted Other: * No other prior malignancy except squamous cell or basal cell skin cancer or stage I or carcinoma in situ of the cervix * No CNS dysfunction that would preclude compliance * HIV negative * No sensitivity to E. coli-derived products * Not pregnant * Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: * Not specified Chemotherapy: * At least 4 weeks since prior chemotherapy * No prior doxorubicin of total dose exceeding 240 mg/m\^2 * No prior paclitaxel of total dose of at least 750 mg/m\^2 * No more than 12 months since prior conventional-dose adjuvant chemotherapy Endocrine therapy: * At least 4 weeks since prior hormonal therapy Radiotherapy: * At least 4 weeks since prior radiotherapy * No prior radiation to the left chest wall Surgery: * Not specified

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 (2)

Banner Good Samaritan Medical Center

Phoenix, Arizona, 85006, United States

Location

City of Hope Comprehensive Cancer Center

Duarte, California, 91010-3000, United States

Location

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Carboplatin; Cyclophosphamide; Doxorubicin; Paclitaxel; Thiotepa; 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; Coordination Complexes; Organic Chemicals; Phosphoramide Mustards; Nitrogen Mustard Compounds; Mustard Compounds; Hydrocarbons, Halogenated; Hydrocarbons; Phosphoramides; Organophosphorus Compounds; Daunorubicin; Anthracyclines; Naphthacenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Polycyclic Compounds; Aminoglycosides; Glycosides; Taxoids; Cyclodecanes; Cycloparaffins; Hydrocarbons, Alicyclic; Diterpenes; Terpenes; Triethylenephosphoramide; Aziridines; Azirines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; 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 National Medical Center

pfrankel@coh.org

(626) 256-4673

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: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 10, 1999
• First Posted: January 27, 2003
• Study Start: May 1, 1999
• Primary Completion: December 1, 2013
• Study Completion: December 1, 2013
• Last Updated: August 4, 2015
• Results First Posted: August 4, 2015

Record last verified: 2015-07

Locations

US (2)