A Phase 3 interventional study of pegfilgrastim and capecitabine in Breast Cancer, sponsored by Institute of Cancer Research, United Kingdom. Status unknown at 152 sites in United Kingdom. Open to participants aged 18 Years to 120 Years. Per ClinicalTrials.gov, last updated 2018-08-08.
Sponsored by Institute of Cancer Research, United Kingdom · Phase 3, Interventional, and Treatment
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. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving combination chemotherapy after surgery may kill any remaining tumor cells. It is not yet known which combination chemotherapy regimen is more effective in treating early stage breast cancer that has been removed by surgery.
PURPOSE: This randomized phase III trial is studying four different combination chemotherapy regimens to compare how well they work in treating patients with early stage breast cancer that has been removed by surgery.
OBJECTIVES:
Primary
Secondary
OUTLINE: This is a multi-center, randomized study. Patients are stratified according to participating center, nodal status (N0 vs N1-3 vs N≥ 4), age (≤ 50 years vs > 50 years), and estrogen receptor (ER) status (negative vs positive). Patients are randomized to 1 of 4 treatment arms.
In all arms, treatment continues in the absence of unacceptable toxicity.
Beginning 3-6 months later, all patients may undergo radiotherapy at the discretion of the principal investigator. Patients with ER- and/or progesterone receptor-positive disease then receive tamoxifen citrate or an aromatase inhibitor for up to 5 years.
Quality of life is assessed in a cohort of 1,000 patients in week 6, week 8 or 12, and week 20 or 24 during treatment and then at 12 and 24 months after randomization.
After completion of study therapy, patients are followed every 6 months for 2 years and then annually for at least 10 years.
Peer Reviewed and Funded or Endorsed by Cancer Research UK.
PROJECTED ACCRUAL: A total of 4,400 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 planned enrollment of 4,400 is above the median of 72 across 9,303 interventional studies indexed under Breast Neoplasms.
Browse Breast Neoplasms studies →Institute of Cancer Research, United Kingdom is the lead sponsor of 111 studies on the registry; 27 are open to participants now.
Counted across the registry records on this site, refreshed daily.
DISEASE CHARACTERISTICS:
Histological diagnosis of invasive breast carcinoma
Completely resected disease by breast-conserving surgery with axillary node clearance or modified radical mastectomy within the past 4-8 weeks
Negative surgical margins required, unless either of the following are true:
No prior or current invasive breast cancer or bilateral breast cancer
Hormone receptor status:
PATIENT CHARACTERISTICS:
PRIOR CONCURRENT THERAPY:
No previous chemotherapy, hormonal therapy or radiotherapy for the treatment of pre-invasive or invasive cancer except for either of the following:
Drug: cyclophosphamide · Drug: epirubicin hydrochloride · Drug: fluorouracil · Drug: methotrexate · Procedure: adjuvant therapy
Biological: pegfilgrastim · Drug: cyclophosphamide · Drug: epirubicin hydrochloride · Drug: fluorouracil · Drug: methotrexate · Procedure: adjuvant therapy
Drug: capecitabine · Drug: epirubicin hydrochloride · Procedure: adjuvant therapy
Biological: pegfilgrastim · Drug: capecitabine · Drug: epirubicin hydrochloride · Procedure: adjuvant therapy
Disease-free survival (DFS) at 5 years
Overall survival at 5 years
Distant DFS at 5 years
Tolerability (including serious adverse events, dose-intensity, and toxicity)
Detailed toxicity
Quality of life
Showing the first 100 of 152 sites.
This study is status unknown, as verified in Aug 2018. You cannot join it, but the record below documents what was studied.
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Institute of Cancer Research, United Kingdom