Status:
COMPLETED
Neoadjuvant Chemotherapy With Myocet/Taxotere/Herceptin for HER2 Positive Breast Cancer Patients
Lead Sponsor:
Spanish Breast Cancer Research Group
Collaborating Sponsors:
Cephalon
Sanofi
Conditions:
Breast Cancer
Eligibility:
FEMALE
18-70 years
Phase:
PHASE1
PHASE2
Brief Summary
This is an open-label study to assess the efficacy and tolerability of the combination Myocet®/Taxotere®/Herceptin® as primary treatment for HER2 positive breast cancer patients. HER2 status will be c...
Detailed Description
Phase II: The average pathological complete response rate reported in other trials is around 11%. The investigators expect to achieve an increase of 14% on this rate; that is, they expect a pathologic...
Eligibility Criteria
Inclusion
- Written informed consent.
- Breast cancer stages II and IIIA with histological diagnoses by true-cut.
- Breast cancer tumours overexpressing HER2neu, centrally confirmed by FISH.
- No evidence of metastasis: bilateral mammography, thorax x-ray, computed tomography (CT)-scan or abdominal echography and bone scintigraphy.
- Estrogen and progesterone hormone receptor status, determined before study registration.
- Age \>= 18 years old.
- Performance status (Karnofsky index) \>= 80.
- Adequate cardiac function by LVEF in the previous 14 days.
- Hematology: neutrophils \>= 2.0 x10\^9/l; platelets \>= 100 x10\^9/l; hemoglobin \>= 10 g/dl.
- Adequate hepatic function: total bilirubin \<= 1x upper normal limit (UNL); SGOT and SGPT \<= 2.5xUNL; alkaline phosphatase \<= 2.5xUNL.
- Adequate renal function: creatinine \<= 1xUNL; creatinine clearance \>= 60 ml/min.
- Patients able to comply with study treatment and follow-up.
- Negative pregnancy test in the previous 14 days.
- Adequate contraceptive method during the study and up to 3 months after definitive surgery.
Exclusion
- HER2neu negative tumours.
- Prior systemic therapy for breast cancer.
- Prior treatment with anthracyclines or taxanes (paclitaxel, docetaxel) for any previous malignancy.
- Prior radiotherapy for breast cancer.
- Bilateral invasive breast cancer.
- Pregnant or lactating women.
- Previous grade \>= 2 motor or sensorial neurotoxicity (National Cancer Institute Common Toxicity Criteria \[NCI CTC\]).
- Other serious comorbidities: congestive heart failure or unstable angina; prior history of myocardial infarction in previous year; uncontrolled hypertension (HT); high risk arrhythmias; history of significant neurological or psychiatric disorders; uncontrolled active infection; active peptic ulcer; unstable diabetes mellitus; dyspnea at rest; or chronic therapy with oxygen.
- Previous or current history of neoplasms different from breast cancer, except for skin carcinoma, cervical in situ carcinoma, or any other tumor curatively treated and without recurrence in the last 10 years; ductal in situ carcinoma in the same breast; lobular in situ carcinoma.
- Chronic treatment with corticosteroids.
- Contraindications for administration of corticosteroids, anthracyclines, docetaxel, trastuzumab or egg derivates.
- Concomitant treatment with other therapy for cancer.
- Males.
Key Trial Info
Start Date :
January 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
February 1 2010
Estimated Enrollment :
73 Patients enrolled
Trial Details
Trial ID
NCT00129896
Start Date
January 1 2004
End Date
February 1 2010
Last Update
March 6 2023
Active Locations (16)
Enter a location and click search to find clinical trials sorted by distance.
1
Hospital Universitario Virgen de los Lirios
Alcoy, Alicante, Spain, 03804
2
Hospital Universitario Germans Trias i Pujol
Badalona, Barcelona, Spain, 08916
3
Althaia-Xarxa Assistencial de Manresa
Manresa, Barcelona, Spain, 08243
4
Corporació Sanitaria Parc Taulí
Sabadell, Barcelona, Spain, 08208