Dose-adjusted Adjuvant FEC Compared to Standard FEC for Breast Cancer

Breast Cancer Clinical Trial

Official title:

SBG 2000-1. Individually Dose-adjusted FEC Compared to Standard FEC as Adjuvant Chemotherapy for Node Positive or High-risk Node Negative Breast Cancer. A Randomized Study by the Scandinavian Breast Group

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03888677
• Other study ID #: SBG 2000-1
• Status: Completed
• Phase: Phase 3
• Start date: February 2001
• Est. completion date: July 2014

Study information

• Verified date: March 2019
• Source: Uppsala University Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

This is an open randomized phase III study. The primary objective of this study is to compare FEC adjuvant chemotherapy in operable breast cancer given either as fixed doses calculated according to the patients surface area or with doses adjusted according to leukopenia after course one in order to achieve hematological equitoxicity. The main aim of the study is to test whether chemotherapy dosage aimed at hematological equitoxicity will improve the effect of adjuvant chemotherapy.

Description:

Group A, FECStandard(standard FEC) is given 7 courses of 5-fluorouracil-epirubicin (Farmorubicin)-cyclophosphamide with doses based on the patient's surface area. Leukocyte nadir values at day 10, 12 or 13 and 15 are measured. Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia.

Group B FECTailored(Tailored FEC) receives course one at identical doses to group A. Leukocyte nadir values at day 10,12 or 13 and 15 are measured. Doses of subsequent courses are adjusted to achieve grade 3 leukopenia (leukocyte nadir 1.0 to 2.0) in patients experiencing only grade 0 to 2 leukopenia after course one.

Dose-reductions of one step according to table 8.2.1 are performed in case of leukopenic fever or grade 4 leukopenia .

Patients achieving only grade 0-2 leukopenia at the first course will be randomized into continued treatment at standard doses (Group A) or to doses tailored to achieve grade 3 leukopenia (Group B). The primary comparisons will be made between these two groups of patients.

Patients with grade 3-4 leukopenia after the first course not be randomized but followed according to the protocol and received treatment as group A, FECStandard.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1535
• Est. completion date: July 2014
• Est. primary completion date: August 2003
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 60 Years

Eligibility

Inclusion Criteria:

• Node positive or 2) High-risk node negative#

• no major cardiovascular morbidity

• female age 18-60

• ECOG/WHO performance status <1

• histologically proven invasive breast cancer

• written or oral witnessed informed consent according to the local Ethics Committee requirements

• start of adjuvant chemotherapy within 8 weeks after surgery

Exclusion Criteria:

• distant metastases (M1)

• locally advanced cancer

• nonradically operated (positive resection margins)

• pregnancy or lactation

• leukocyte count < 3.5 x109 /l

• platelets < 100 x109 /l

• other serious medical condition

• previous or concurrent malignancies at other sites, except basal cell carcinoma and carcinoma cervicis uteri in situ

Related Conditions & MeSH terms

• Breast Cancer
• Breast Neoplasms

Intervention

Drug:
• 5-FU, epirubicin and cyclophosphamide
Tailored dose escalation of epirubicin and cyclophosphamide.

Locations

Country	Name	City	State
n/a

Sponsors (7)

Lead Sponsor	Collaborator
Henrik Lindman	Danish Breast Cancer Cooperative Group, Pharmacia Pharmaceutical Company, Scandinavian Breast Group, Swedish Breast Cancer Group, Swedish Cancer Foundation, Swedish Cancer Society

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Distant disease-free survival.	Distant disease-free survival comparing standard and tailored arm.	5-10 years
Secondary	Regio-locally relapsed disease	Regiolocal disease-free survival	5-10 years
Secondary	Overall survival	Overall survival	5-10 years
Secondary	Toxicity of treatment.	Adverse events	5-10 years
Secondary	Leukopenia and correlation to prognosis in distant disease-free survival.	Distant disease-free survival in patients groups based on nadir leukopenia after third cycle.	5-10 years.
Secondary	Effect of dose escalation of leukopenia and correlation to prognosis in distant disease-free survival.	Comparing distant disease-free survival difference between patients randomized to tailored and dose-escalated FEC with the Group of patients with standard FEC but with similar grade of leukopenia.	5-10 years.