Phase-IIb-Study to Evaluate the Effect of a Neoadjuvant Chemotherapy with Docetaxel, Epirubicine and Cyclphosphamide (TEC) in Patients with primary HER-2 neu Negative Mammacarcinoma

Phase 2

• Conditions: MedDRA - 10006187: Primary mamma carcinoma; C50; Malignant neoplasm of breast

• Registration Number: DRKS00000162
• Lead Sponsor: niversität Leipzig

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2009-07-20
• Study Completion: 2016-07-07
• Last Update Posted: 19 August 2024

Recruitment & Eligibility

• Status: Complete
• Sex: Female
• Target Recruitment: 152

Inclusion Criteria

Women with histologically verified mamma carcinoma (assessment of estrogen and progesterone receptors, grading, negative HER-2/neu status)
- All receptor-negative mamma carcinoma starting from cT1c, all receptor-positive mamma carcinoma starting from cT3, cT4 includes inflammatory mamma carcinoma
- In case of cT2 and receptor-positivity, N+ is required and can also be detected with sentinel node biopsy
- In case of cT1c and receptor-positivity, a positive lymph node must be verified with sentinel node biopsy (pNsn+)
- Clinically and with an imaging technology (sonography or mammography) measurable primary tumor
- Sufficient bone marrow reserve: number of neutrophils higher/equal 1,5 x 1000000000/L, number of thrombocytes higher/equal 100 x 1000000000/L, hemoglobin higher/equal 6,2 mmol/L
- Sufficient liver and renal function: bilirubin smaller/equal 1 x upper limit of quantification (ULQ), ASAT (SGOT) and ALAT (SGPT) smaller 1,5 x ULQ, alcalic phosphatase smaller 1,5 x ULQ, Creatinine smaller 1 x ULQ (if creatinine higher ULQ creatinine clearance must be higher 60 mL/minute)
- Age-appropriate cardiologically normal findings as documented by ECG and LVEF (echocardiographical) assessments before beginning the therapy
- ECOG-performance-status of 0-2
- Age greater/equal 18 years
- Written informed consent of the patient including compliance of the patient regarding the therapy and the follow-up must be available before enrolment and documented according to the local regulations.

Exclusion Criteria

Pregnant or nursing women. Positive pregnancy test (urine or serum) within 7 days before registration
- Previous surgical, cytostatic or hormonal therapy (with exception of hormone substitution or contraception), no previous immune or radiation therapy
- Women with child bearing potency (menopause according to hormone status) without effective non-hormonal contraception (intra-uterine devices such as spirals, condoms in combination with additional contraceptic measures, vasectomised partner) during the participation in the study and 6 months after the end of study therapy.
- Bilateral localisation of tumors
- Evidence of distant metastases after complete staging with chest X-ray, upper abdomen sonography, and/or CT and bone scintigraphy
- Pre-existing motor or sensor neurotoxicity > grade 2 (according to NCl criteria)
- Pre-existing cardiac disease not permitting the participation in this study (e.g. severe heart insufficiency or unstable angina pectoris, cardiac infarction within one year before study entry, uncontrolled hypertension, therapy resistant arrhythmia
- Significant neurological or psychiatric disease in the anamnesis (including psychotic disorders, dementia or seizures) compromising the understanding of the trial and consent to the trial.
- Drug abuse
- Active infection
- Florid ulcus, unstable diabetes mellitus
- Previously diagnosed tumor with exception of basalioma or in situ carcinoma of the cervix or other cancers having been treated curatively and having been followed by a disease-free interval of < 10 years.
- Chronic treatment with corticosteroids if not started > 6 months before study entry and at low doses (< 20 mg Methylprednisolone or equivalents)
- Clear contraindication for the application of corticosteroids
- Contraindication of the planned therapy:
- hypersensitivity to one of the trial drugs (Docetaxel, Cyclophosphamide and Epirubicine)
- extensive inflammatory condition of oral or gastrointestinal mucous membrane
- Lack of compliance
- Concomitant participation in other clinical trials

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Estimation of the complete remission rate of invasive tumor cells in the breast confirmed by histological examinations, at surgery.

Secondary Outcome Measures

Name	Time	Method
Tumor response according to clinical criteria determined by sonogrphy at surgery.<br>Tumor response according to pathological criteria determined by histology at surgery.<br>Rate of breast-conserving surgery <br>Toxicity associated with the therapy at each performed chemotherapy cycle.<br>Disease free survival until study end<br>Overall survival until study end