A Phase 2 interventional study of pegfilgrastim and epirubicin hydrochloride in Breast Cancer, sponsored by Case Comprehensive Cancer Center. Completed at 1 site in United States. Open to female participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2020-07-24.
Sponsored by Case Comprehensive Cancer Center · Phase 2, Interventional, and Treatment
RATIONALE: Drugs used in chemotherapy, such as epirubicin, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving epirubicin before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well epirubicin works in treating women who are undergoing surgery for stage I, stage II, or stage III breast cancer.
OBJECTIVES:
Primary
Secondary
OUTLINE: Patients receive epirubicin hydrochloride IV on day 1 and pegfilgrastim subcutaneously on day 2. Treatment repeats every 14 days for 4 courses in the absence of disease progression or unacceptable toxicity. Four weeks later, patients undergo partial mastectomy or simple mastectomy plus an axillary staging procedure.
After completion of study treatment, patients are followed periodically.
PROJECTED ACCRUAL: A total of 30 patients will be accrued for this study.
12,544 studies on the registry are indexed under Breast Neoplasms; 2,892 are open to participants now.
This study's enrollment of 15 is below the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Case Comprehensive Cancer Center is the lead sponsor of 484 studies on the registry; 59 are open to participants now.
Of its 74 completed or terminated interventional studies of FDA-regulated products, 45 (61%) have results posted.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histologically confirmed invasive breast cancer
Stage I, II, or III disease (T1, T2, or T4; N0-2; M0)
Unidimensionally measurable disease
Hormone receptor status:
PATIENT CHARACTERISTICS:
Sex
Menopausal status
Performance status
Life expectancy
Hematopoietic
Hepatic
Renal
Cardiovascular
Other
PRIOR CONCURRENT THERAPY: Not specified
Biological: pegfilgrastim · Drug: epirubicin hydrochloride · Procedure: conventional surgery
6 mg in a syringe
Also known as: Neulasta
120 MG q 2 weeks for 4 cycles
to remove small piece of cancer
Also known as: Biopsy will involve a small surgical incision to remove a piece of the cancer.
Complete pathological response rate by tumor analysis after surgery
No evidence of microscopic invasive tumor at the primary tumor site in the surgical specimen.
Time frame: 4 weeks
Complete clinical response rate by diagnostic mammogram at baseline and at 8 weeks
Bilateral (if both breasts are present) Mammograms (within 4 weeks of study entry)
Time frame: 4 weeks
Toxicity by physical exam and medical history every 14 days prior to surgery
A physical exam Physical examination with recording of tumor size, if palpable.
Time frame: 2-4 weeks
Predictive value of HER2 gene amplification and topoisomerase II-alpha gene amplification or deletions for pathologic complete response, clinical complete response or disease progression after surgery
Patients whose tumors are positive for estrogen receptor (\>1% staining by immunohistochemistry) or progesterone receptor (institutional definition) should receive post-operative hormonal therapy for 5 years.
Time frame: 5 years
Gene expression after surgery
Patients whose tumors are positive for estrogen receptor (\>1% staining by immunohistochemistry) or progesterone receptor (institutional definition) should receive post-operative hormonal therapy for 5 years.
Time frame: 5 years
This study is completed, as verified in Jul 2020. You cannot join it, but the record below documents what was studied.
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Case Comprehensive Cancer Center