Phase 2 N=32 Treatment

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

Breast Cancer

Bottom Line

View on ClinicalTrials.gov: NCT00182793 ↗

Enrolled (actual)

Serious AEs

75.0%

Results posted

Feb 2017

Primary outcome: Primary: 5-Year Relapse-free Survival Rate — 53 percentage of participants

Study Design & Population

Study type: Interventional
Phase: Phase 2
Interventions: trastuzumab (Biological); carboplatin (Drug); cyclophosphamide (Drug); melphalan (Drug); thiotepa (Drug); adjuvant therapy (Procedure); autologous-autologous tandem hematopoietic stem cell transplantation (Procedure); bone marrow ablation with stem cell support (Procedure); radiation therapy (Radiation)
Age: Pediatric, Adult, Older Adult
Sex: All
Sponsor: City of Hope Medical Center
Primary completion: Oct 2014

Outcome Measures

Outcome	Result	p-value
PRIMARY 5-Year Relapse-free Survival Rate	53	—
PRIMARY 5-Year Overall Survival Rate	75	—

Summary

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.

Eligibility 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

View full record on ClinicalTrials.gov →

Data sourced from ClinicalTrials.gov (NCT00182793). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.