Combination Chemotherapy With or Without Trastuzumab Followed By an Autologous Stem Cell Transplant and Radiation Therapy in Treating Patients With Stage III or Stage IV Breast Cancer - Full Text View

Sponsors and Collaborators:	Beckman Research Institute National Cancer Institute (NCI)
Information provided by:	National Cancer Institute (NCI)
ClinicalTrials.gov Identifier:	NCT00182793

Purpose

RATIONALE: Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. An autologous stem cell transplant may be able to replace blood-forming cells that were destroyed by chemotherapy. Radiation therapy uses high-energy x-rays to kill tumor cells. Giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy may kill more tumor cells.

PURPOSE: This phase II trial is studying how well giving combination chemotherapy with or without trastuzumab followed by an autologous stem cell transplant and radiation therapy works in treating patients with stage III or stage IV breast cancer.

Condition	Intervention	Phase
Breast Cancer	Drug: carboplatin Drug: cyclophosphamide Drug: melphalan Drug: thiotepa Drug: trastuzumab Procedure: adjuvant therapy Procedure: autologous-autologous tandem hematopoietic stem cell transplantation Procedure: bone marrow ablation with stem cell support Procedure: radiation therapy	Phase II

Genetics Home Reference related topics: breast cancer

MedlinePlus related topics: Breast Cancer Cancer

Drug Information available for: Cyclophosphamide Carboplatin Melphalan Thiotepa Melphalan hydrochloride Sarcolysin Trastuzumab

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Treatment, Open Label
Official Title:	Phase II Study of Tandem Cycle Dose-Intense Chemotherapy of Melphalan and Carboplatin, Thiotepa and Cyclophosphamide (STMP V) ± Trastuzumab Followed by Helical Tomotherapy or Local Regional Radiation Therapy for Stage IV Metastatic and Stage IIIB/C Breast Cancer

Further study details as provided by National Cancer Institute (NCI):

Primary Outcome Measures:

Time to relapse and/or progression [ Designated as safety issue: No ]
Overall survival [ Designated as safety issue: No ]
Response rate for stage IV breast cancer at year 5 [ Designated as safety issue: No ]
Feasibility [ Designated as safety issue: No ]

Secondary Outcome Measures:

Assessment of tumor markers and biology [ Designated as safety issue: No ]

Estimated Enrollment:	100
Study Start Date:	July 2005
Estimated Primary Completion Date:	December 2010 (Final data collection date for primary outcome measure)

Detailed Description:

OBJECTIVES:

Determine the feasibility of tandem high-dose chemotherapy comprising melphalan, carboplatin, thiotepa, and cyclophosphamide with or without trastuzumab (Herceptin®) followed by autologous peripheral blood stem cell transplantation and helical tomotherapy or loco-regional radiotherapy in patients with high-risk stage IIIB, IIIC, or IV breast cancer.
Determine the toxic effects of this regimen in these patients.

OUTLINE: Patients undergo stem cell collection.

Course 1: Patients receive high-dose melphalan IV with or without trastuzumab (Herceptin®). One day later, patients undergo autologous peripheral blood stem cell (PBSC) transplantation. No more than 7 weeks later, patients proceed to course 2.
Course 2: Patients receive high-dose carboplatin, thiotepa, and cyclophosphamide IV continuously over 4 days followed by autologous PBSC transplantation.

After recover from high-dose chemotherapy and autologous PBSC transplantation, patients with stage IIIB or IIIC disease undergo radiotherapy to the chest wall and lymph nodes. Patients with stage IV disease undergo radiotherapy using helical tomotherapy or standard radiotherapy to oligometastatic sites.

PROJECTED ACCRUAL: A total of 100 patients will be accrued for this study.

Eligibility

Ages Eligible for Study:	up to 65 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

DISEASE CHARACTERISTICS:

Histologically confirmed breast cancer, meeting 1 of the following stage criteria:
- Stage IIIB or IIIC disease, meeting both of the following criteria:
  - Must have received prior neoadjuvant or adjuvant therapy
  - Must have undergone lumpectomy or mastectomy
- Stage IV disease, meeting all of the following criteria:
  - Only 1-3 organ sites with disease involvement after induction chemotherapy
  - Achieved at least a partial response after induction chemotherapy
  - No more than 3 lesions in the organ sites combined
Inflammatory breast cancer allowed
Completed chemotherapy, surgery, or radiotherapy for breast cancer within the past 6 months
Hormone receptor status:
- Not specified

PATIENT CHARACTERISTICS:

Age

65 and under

Sex

Male or female

Menopausal status

Not specified

Performance status

Karnofsky 80-100%

Life expectancy

Not specified

Hematopoietic

Absolute neutrophil count ≥ 1,000/mm^3
Platelet count ≥ 100,000/mm^3

Hepatic

SGOT or SGPT ≤ 2 times upper limit of normal
Bilirubin ≤ 1.5 mg/dL

Renal

Creatinine ≤ 1.2 mg/dL
Creatinine clearance ≥ 70 mL/min

Cardiovascular

LVEF ≥ 55% by MUGA or echocardiogram

Pulmonary

FEV_1 ≥ 60% of predicted
DLCO ≥ 60% of the lower limit of predicted value
Oxygen saturation > 92% on room air

Other

Not pregnant or nursing
Negative pregnancy test
Fertile patients must use effective contraception
No autoimmune disorders
No immunosuppressive condition
No other malignancy within the past 5 years

PRIOR CONCURRENT THERAPY:

Biologic therapy

No prior biologic therapy except trastuzumab (Herceptin®)

Chemotherapy

See Disease Characteristics

Endocrine therapy

Not specified

Radiotherapy

See Disease Characteristics
No prior radiotherapy to adjacent or involved sites of disease that would preclude study radiotherapy

Surgery

See Disease Characteristics

Other

No other concurrent anticancer therapy

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00182793

Locations

United States, California
City of Hope Comprehensive Cancer Center	Recruiting
Duarte, California, United States, 91010-3000
Contact: Clinical Trials Office - City of Hope Comprehensive Cancer Cen 800-826-4673 becomingapatient@coh.org

Sponsors and Collaborators

Beckman Research Institute

National Cancer Institute (NCI)

More Information

Clinical trial summary from the National Cancer Institute's PDQ® database This link exits the ClinicalTrials.gov site

Responsible Party:	City of Hope Comprehensive Cancer Center ( George Somlo )
Study ID Numbers:	CDR0000442105, CHNMC-05042
Study First Received:	September 15, 2005
Last Updated:	November 12, 2008
ClinicalTrials.gov Identifier:	NCT00182793
Health Authority:	Unspecified

Keywords provided by National Cancer Institute (NCI):

stage IIIB breast cancer
stage IIIC breast cancer
stage IV breast cancer
inflammatory breast cancer
male breast cancer
recurrent breast cancer
invasive ductal breast carcinoma with predominant intraductal component
invasive ductal breast carcinoma

medullary ductal breast carcinoma with lymphocytic infiltrate
mucinous ductal breast carcinoma
Paget disease of the breast with invasive ductal carcinoma
papillary ductal breast carcinoma
tubular ductal breast carcinoma
invasive lobular breast carcinoma with predominant in situ component
invasive lobular breast carcinoma
comedo ductal breast carcinoma

Study placed in the following topic categories:

Melphalan
Skin Diseases
Breast Neoplasms
Carboplatin
Cyclophosphamide
Recurrence
Thiotepa
Carcinoma
Pagets disease

Carcinoma, Ductal
Carcinoma, Lobular
Inflammatory breast cancer
Breast Neoplasms, Male
Osteitis Deformans
Trastuzumab
Carcinoma, Ductal, Breast
Breast Diseases

Additional relevant MeSH terms:

Immunologic Factors
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Physiological Effects of Drugs
Immunosuppressive Agents
Pharmacologic Actions
Neoplasms

Neoplasms by Site
Therapeutic Uses
Myeloablative Agonists
Antineoplastic Agents, Alkylating
Antirheumatic Agents
Alkylating Agents

ClinicalTrials.gov processed this record on January 15, 2009