NCT00301548

Brief Summary

The role of early timing of adjuvant chemotherapy was postulated to be particularly important for patients with endocrine non-responsive disease. The role of cytotoxicity during the period of breast surgery itself and immediately after (perioperative chemotherapy) remained unknown. We investigated in a randomized trial the role of perioperative chemotherapy in patients treated with a preoperative chemotherapy for locally advanced breast cancer and compare it to the preoperative chemotherapy without additional cytotoxic therapy during and immediately after definitive surgery. Patients with T2-3 N0-2 M0 breast cancer, with both estrogen receptors (ER) and progesterone receptors (PgR) expressed in less than 20% of tumor cells, or with absence of progesterone receptors, received up to 6 courses of primary systemic therapy with epirubicin 25 mg/m2 intravenously (i.v.) on days 1 and 2, cisplatin 60 mg/m2 i.v. on day 1, and 5-fluorouracil 200 mg/m2 i.v. daily as continuous infusion (ECF). Patients achieving a partial or complete remission were randomized to continue the infusion of fluorouracil until 2 weeks after surgery (perioperative treatment arm) or to stop fluorouracil infusion one week before surgery, on day 21 of the sixth cycle (control arm).

Trial Health

100
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
172

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Feb 2000

Longer than P75 for phase_2

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2000

Completed
5.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2005

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

March 9, 2006

Completed
4 days until next milestone

First Posted

Study publicly available on registry

March 13, 2006

Completed
Last Updated

March 13, 2006

Status Verified

January 1, 2006

First QC Date

March 9, 2006

Last Update Submit

March 9, 2006

Conditions

Breast NeoplasmsCarcinoma

Keywords

antineoplastic protocolsneoadjuvant therapyperioperative chemotherapyfluorouracil

Outcome Measures

Primary Outcomes (1)

  • Reduction in Ki-67 labeling index

Secondary Outcomes (3)

  • Pathological complete remission rate

  • Disease-free survival

  • Toxicity and safety

Interventions

perioperative chemotherapyDRUG

Eligibility Criteria

Age18 Years - 70 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Patients with breast cancer histologically proven \> 2 cm, ER and PgR \<20% or Any ER and PgR absent (T2,T3 N0-2, M0)
  • No treatment with previous chemotherapy/hormonotherapy
  • Performance status 0-2 (ECOG scale, Appendix 2)
  • Measurable or evaluable lesions
  • Age between 18-70 years
  • No significant intercurrent illness such as diabetes, cardiovascular, renal or neurologic impairments
  • Absence of psychiatric illness
  • WBC \> 4,000/mm3; PLTS \> 100,000/mm3
  • AST, ALT, LDH, gamma-GT \< 2.5 x upper limit of normal and bilirubin \< 3 mg/100 ml
  • Informed consent obtained
  • Pregnancy test (in fertile women). An effective contraceptive method must be utilized by fertile women.
  • Baseline examinations (chest X ray, CT scan, ECG etc) performed within one month prior initiation to therapy

You may not qualify if:

  • Uncontrolled infection and metabolite disease
  • Distant metastases
  • Active peripheric and/or central neurological disease
  • Active cardiac disease defined as CHF (NYHA III-IV) significant arrhytmias, bilateral bundle branch block or recent (less than 3 months) history of myocardial infarction
  • History of second malignancy (exception in situ carcinoma of the uterine cervix and basal or squamous cell carcinoma of the skin)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (3)

  • Clahsen PC, van de Velde CJ, Goldhirsch A, Rossbach J, Sertoli MR, Bijnens L, Sylvester RJ. Overview of randomized perioperative polychemotherapy trials in women with early-stage breast cancer. J Clin Oncol. 1997 Jul;15(7):2526-35. doi: 10.1200/JCO.1997.15.7.2526.

    PMID: 9215821BACKGROUND

  • Colleoni M, Gelber S, Coates AS, Castiglione-Gertsch M, Gelber RD, Price K, Rudenstam CM, Lindtner J, Collins J, Thurlimann B, Holmberg SB, Cortes-Funes H, Simoncini E, Murray E, Fey M, Goldhirsch A; International Breast Cancer Study Group. Influence of endocrine-related factors on response to perioperative chemotherapy for patients with node-negative breast cancer. J Clin Oncol. 2001 Nov 1;19(21):4141-9. doi: 10.1200/JCO.2001.19.21.4141.

    PMID: 11689582BACKGROUND

  • Ludwig Breast Cancer Study Group. Prolonged disease-free survival after one course of perioperative adjuvant chemotherapy for node-negative breast cancer. N Engl J Med. 1989 Feb 23;320(8):491-6. doi: 10.1056/NEJM198902233200804.

    PMID: 2644533BACKGROUND

MeSH Terms

Conditions

Breast NeoplasmsCarcinoma

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasmsBreast DiseasesSkin DiseasesSkin and Connective Tissue DiseasesNeoplasms, Glandular and EpithelialNeoplasms by Histologic Type

Study Officials

  • Colleoni A Marco, MD

    European Institute of Oncology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER

Study Record Dates

First Submitted

March 9, 2006

First Posted

March 13, 2006

Study Start

February 1, 2000

Study Completion

June 1, 2005

Last Updated

March 13, 2006

Record last verified: 2006-01