S9623, Combination Chemotherapy Plus Peripheral Stem Cell Transplantation in Treating Women With Breast Cancer

NCT00002772 | Terminated Phase 3 DMC

• 3 other identifiers: CDR0000064747S9623U10CA032102
• Study Type: interventional
• Target: 602
• 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. Peripheral stem cell transplantation may allow the doctor to give higher doses of chemotherapy drugs and kill more tumor cells. It is not yet known which regimen of chemotherapy followed by peripheral stem cell transplantation is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of combination chemotherapy plus peripheral stem cell transplantation in treating women who have undergone surgery for breast cancer.

Conditions

Breast Cancer

Keywords

stage II breast cancer; stage IIIA breast cancer

Study Arms (2)

High dose chemo

EXPERIMENTAL

sequential high dose chemotherapy with doxorubicin, paclitaxel and cyclophosphamide with filgrastim support

Biological: filgrastim; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Drug: tamoxifen citrate; Radiation: radiation therapy

chemo with autologous stem cell support

EXPERIMENTAL

conventional chemotherapy with doxorubicin and cyclophosphamide followed by autologous stem cell support

Drug: carboplatin; Drug: carmustine; Drug: cisplatin; Drug: cyclophosphamide; Drug: doxorubicin hydrochloride; Drug: paclitaxel; Drug: tamoxifen citrate; Drug: thiotepa; Procedure: autologous bone marrow transplantation; Procedure: peripheral blood stem cell transplantation

Interventions

filgrastim BIOLOGICAL

High dose chemo

carboplatin DRUG

chemo with autologous stem cell support

carmustine DRUG

chemo with autologous stem cell support

cisplatin DRUG

chemo with autologous stem cell support

cyclophosphamide DRUG

High dose chemo; chemo with autologous stem cell support

doxorubicin hydrochloride DRUG

High dose chemo; chemo with autologous stem cell support

paclitaxel DRUG

High dose chemo; chemo with autologous stem cell support

tamoxifen citrate DRUG

High dose chemo; chemo with autologous stem cell support

thiotepa DRUG

chemo with autologous stem cell support

autologous bone marrow transplantation PROCEDURE

chemo with autologous stem cell support

peripheral blood stem cell transplantation PROCEDURE

chemo with autologous stem cell support

radiation therapy RADIATION

High dose chemo

Eligibility Criteria

• Age: 18 Years+
• Sex: female
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

DISEASE CHARACTERISTICS: Histologically proven adenocarcinoma of the breast with at least 4 involved axillary and/or intramammary lymph nodes No known T4, N3, or M1 disease Dermal lymphatic involvement without clinical inflammatory changes (edema, peau d'orange, erythema) allowed Must have undergone breast conserving surgery or modified radical mastectomy plus axillary lymph node dissection Surgical margins negative for invasive or noninvasive ductal carcinoma At least 10 nodes sampled No more than 12 weeks since definitive surgery Synchronous bilateral breast carcinoma allowed if: Diagnosed within 4 weeks of initial histologic diagnosis One breast meets the eligibility criteria Other breast has fewer than 10 involved nodes and is not N3 or T4 Both breasts treated by modified radical mastectomy or breast conserving surgery with axillary node dissection Concurrent registration on S9719 Hormone receptor status: Not specified PATIENT CHARACTERISTICS: Age: Adult Sex: Female Menopausal status: Any status Performance status: SWOG 0 or 1 Hematopoietic: WBC at least 3,000/mm3 Absolute neutrophil count at least 1,000/mm3 Platelet count at least 100,000/mm3 Hepatic: Bilirubin no greater than 1.5 times upper limit of normal (ULN) SGOT no greater than 1.5 times ULN Hepatitis C status required Renal: Creatinine clearance at least 60 mL/min Cardiovascular: Left ventricular ejection fraction at rest at least 45% by MUGA No EKG abnormalities unless cleared by a cardiologist No uncontrolled or significant cardiac disease No congestive heart failure No second or third degree heart block or other serious cardiac conduction abnormality No atrial or ventricular arrhythmia No requirement for medication known to affect cardiac conduction unless: Given for reasons other than heart failure or arrhythmia Cleared by a cardiologist Pulmonary: FVC and FEV1 at least 60% predicted DLCO at least 60% predicted Other: HIV negative Hepatitis B surface antigen status required No serious medical or psychiatric illness that would preclude informed consent or study participation No second malignancy within the past 5 years except adequately treated basal cell or squamous cell skin cancer, carcinoma in situ of the cervix, or intraductal or lobular carcinoma of the breast (diagnosed at any time) Not pregnant or nursing Fertile patients must use effective contraception PRIOR CONCURRENT THERAPY: Biologic therapy: Not specified Chemotherapy: No prior chemotherapy Endocrine therapy: No prior hormonal therapy for breast cancer Radiotherapy: No prior radiotherapy to the breast Surgery: See Disease Characteristics

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

Sponsors & Collaborators

• SWOG Cancer Research Network: lead
• National Cancer Institute (NCI): collaborator
• Eastern Cooperative Oncology Group: collaborator
• Cancer and Leukemia Group B: collaborator

Study Sites (1)

Memorial Sloan-Kettering Cancer Center

New York, New York, 10021, United States

Location

Related Publications (2)

• Moore HC, Green SJ, Gralow JR, Bearman SI, Lew D, Barlow WE, Hudis C, Wolff AC, Ingle JN, Chew HK, Elias AD, Livingston RB, Martino S; Southwest Oncology Group/Intergroup Study 9623. Intensive dose-dense compared with high-dose adjuvant chemotherapy for high-risk operable breast cancer: Southwest Oncology Group/Intergroup study 9623. J Clin Oncol. 2007 May 1;25(13):1677-82. doi: 10.1200/JCO.2006.08.9383. Epub 2007 Apr 2.

  PMID: 17404368 RESULT

• Bearman SI, Green S, Gralow J, et al.: SWOG/Intergroup 9623: a phase III comparison of intensive sequential chemotherapy to high dose chemotherapy and autologous hematopoietic progenitor cell support (AHPCS) for primary breast cancer in women with =4 involved axillary lymph nodes. [Abstract] J Clin Oncol 23 (Suppl 16): A-572, 21s, 2005.

  RESULT

MeSH Terms

Conditions

Breast Neoplasms

Interventions

Filgrastim; Carboplatin; Carmustine; Cisplatin; Cyclophosphamide; Doxorubicin; Paclitaxel; Tamoxifen; Thiotepa; Peripheral Blood Stem Cell Transplantation; Radiotherapy

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; Nitrosourea Compounds; Urea; Amides; Nitroso Compounds; Chlorine Compounds; Inorganic Chemicals; Nitrogen Compounds; Platinum Compounds; 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; Stilbenes; Benzylidene Compounds; Benzene Derivatives; 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

Study Officials

• Scott I. Bearman, MD

  University of Colorado, Denver

  STUDY CHAIR

• Antonio C. Wolff, MD

  Sidney Kimmel Comprehensive Cancer Center at Johns Hopkins

  STUDY CHAIR

• Clifford A. Hudis, MD

  Memorial Sloan Kettering Cancer Center

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: NETWORK
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 1, 1999
• First Posted: April 22, 2004
• Study Start: July 1, 1996
• Primary Completion: February 1, 2004
• Study Completion: February 1, 2004
• Last Updated: January 24, 2013

Record last verified: 2013-01

Locations

US (1)