Clinical Trial: Combination Chemotherapy and Peripheral Stem Cell Transplantation in Treating Patients With Stage II or Stage IIIA Breast Cancer

This study is no longer recruiting patients.

Sponsors and Collaborators: National Cancer Institute (NCI)
Fred Hutchinson Cancer Research Center
Information provided by: National Cancer Institute (NCI)

Purpose

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. It is not yet known which regimen of combination chemotherapy is more effective for breast cancer. PURPOSE: Randomized phase III trial to compare the effectiveness of two regimens of combination chemotherapy followed by peripheral stem cell transplantation in treating patients who have stage II or stage IIIA breast cancer.

Condition Treatment or Intervention Phase
stage IIIA breast cancer
stage II breast cancer
 Drug: busulfan
 Drug: carboplatin
 Drug: cyclophosphamide
 Drug: filgrastim
 Drug: melphalan
 Drug: paclitaxel
 Drug: sargramostim
 Drug: tamoxifen
 Drug: thiotepa
Phase III

MedlinePlus related topics:  Breast Cancer
Genetics Home Reference related topics:  breast cancer

Study Type: Interventional
Study Design: Treatment

Official Title: Phase III Randomized Study of High Dose Busulfan, Melphalan, and Thiotepa Versus Cyclophosphamide, Thiotepa, and Carboplatin Followed By Autologous Peripheral Blood Stem Cell Transplantation in Patients with Node Positive Stage II or IIIA Breast Cancer

Further Study Details: 

Study start: July 1998

OBJECTIVES: I. Compare early mortality, survival, and disease free survival in patients with node positive stage II or IIIA breast cancer treated with busulfan, melphalan, and thiotepa versus cyclophosphamide, thiotepa, and carboplatin followed by autologous peripheral blood stem cell transplantation. II. Compare the toxicity of these 2 regimens in this patient population.

PROTOCOL OUTLINE: This is a randomized study. Patients are stratified according to stage of disease (stage II vs stage IIIA), lymph node status (at least 10 positive nodes vs less than 10 positive nodes), and hormone receptor status (estrogen receptor positive or progesterone receptor positive vs estrogen receptor negative or progesterone receptor negative). All patients initially receive mobilization chemotherapy with cyclophosphamide IV over 1-2 hours on day 1 and paclitaxel IV over 4 hours on day 2. Beginning on day 4, patients receive filgrastim (G-CSF) or sargramostim (GM-CSF) subcutaneously each day until the final day of leukapheresis. When blood counts recover, peripheral blood stem cells (PBSC) are harvested. Patients are randomized to 1 of 2 high dose chemotherapy regimens 28-45 days after the last dose of mobilization chemotherapy. Arm I: Patients receive oral busulfan every 6 hours on days -8 to -6, melphalan IV over 30-60 minutes on days -5 and -4, and thiotepa IV over 2 hours on days -3 and -2. PBSC are reinfused on day 0. Arm II: Patients receive cyclophosphamide, thiotepa, and carboplatin by continuous IV infusion over 24 hours on days -7, to -4. PBSC are reinfused on day 0. Beginning 4-6 weeks after the last dose of chemotherapy, patients in both arms receive local radiotherapy 5 days each week for 5 weeks. Patients also receive oral tamoxifen (or equivalent antiestrogen therapy) daily for 5 years if they are estrogen or progesterone receptor positive, postmenopausal, or age 50 and over and perimenopausal. Patients are followed every 3 months for 2 years and then every 6 months thereafter.

PROJECTED ACCRUAL: A total of 280 patients (140 per treatment arm) will be accrued for this study over 3 years.

Eligibility

Ages Eligible for Study:  18 Years   -   65 Years

Criteria

PROTOCOL ENTRY CRITERIA:

--Disease Characteristics--

--Prior/Concurrent Therapy--

  • Biologic therapy: Not specified
  • Chemotherapy: See Disease Characteristics; No greater than 1 prior chemotherapy regimen (no greater than 7 prior courses)
  • Endocrine therapy: No concurrent tamoxifen
  • Radiotherapy: Not specified
  • Surgery: See Disease Characteristics
  • Other: No other concurrent experimental agents

--Patient Characteristics--

  • Age: 18 to 65
  • Menopausal status: Not specified
  • Performance status: Karnofsky 70-100%
  • Life expectancy: Not specified
  • Hematopoietic: Not specified
  • Hepatic: Bilirubin no greater than 2.0 mg/dL; SGOT or SGPT no greater than 2 times normal
  • Renal: Creatinine no greater than 2.0 mg/dL OR Creatinine clearance at least 60 mL/min
  • Cardiovascular: Left ventricular ejection fraction at least 50% if any of the following: Symptoms of congestive heart failure; Abnormal cardiac exam; Prior doxorubicin dose greater than 400 mg/m2
  • Pulmonary: No significant pulmonary disease (DLCO less than 60% predicted)
  • Other: Not pregnant; Negative pregnancy test; HIV negative; No significant active infection; No other severe disease that would severely limit life expectancy; No other malignancy within past 5 years unless: Chance of survival for greater than 5 years is 90% AND Treated with surgery only (no chemotherapy or radiotherapy)

Location Information


Washington
      Fred Hutchinson Cancer Research Center, Seattle,  Washington,  98109,  United States

Study chairs or principal investigators

William I. Bensinger,  Study Chair,  Fred Hutchinson Cancer Research Center   

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database

Study ID Numbers:  CDR0000067175; FHCRC-1316.00; NCI-G99-1552; PSOC-1604
Record last reviewed:  April 2004
Last Updated:  October 13, 2004
Record first received:  November 1, 1999
ClinicalTrials.gov Identifier:  NCT00003972
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-04-08


Source: ClinicalTrials.gov
Cache Date: April 9, 2005

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