- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00301548
Perioperative Chemotherapy After Primary Chemotherapy for Locally Advanced Breast Cancer
March 9, 2006 updated by: European Institute of Oncology
Primary Chemotherapy Combined With Perioperative Chemotherapy In Operable Breast Cancer
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).
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment
172
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 70 years (Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Female
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
---|
Reduction in Ki-67 labeling index
|
Secondary Outcome Measures
Outcome Measure |
---|
Disease-free survival
|
Toxicity and safety
|
Pathological complete remission rate
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Colleoni A Marco, MD, European Institute of Oncology
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
General Publications
- 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.
- 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.
- 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.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2000
Study Completion
June 1, 2005
Study Registration Dates
First Submitted
March 9, 2006
First Submitted That Met QC Criteria
March 9, 2006
First Posted (Estimate)
March 13, 2006
Study Record Updates
Last Update Posted (Estimate)
March 13, 2006
Last Update Submitted That Met QC Criteria
March 9, 2006
Last Verified
January 1, 2006
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- IEO S31/499
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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