Her2/neu negative primary breast cancer, node positive disease or node negative disease with at least one other risk factor (tumor size >2cm, grade > or = 2, ER and PR negative, high uPA/PAI 1 level, RS>11 for ER/PR positive patients with 0-3 positive LN) MedDRA version: 19.0 Level: PT Classification code 10057654 Term: Breast cancer female System Organ Class: 10029104 - Neoplasms benign, malignant and unspecified (incl cysts and polyps)
Conditions
Sponsors
Westdeutsche Studiengruppe GmbH
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: General Inclusion Criteria (Screening) 1. Female patients, age at diagnosis 18 - 75 years 2. Histological confirmed unilateral primary invasive carcinoma of the breast 3. Adequate surgical treatment with complete resection of the tumor (R0) and resection of ? 10 axillary nodes or SLN in clinically N0 patients 4. T1 - T4 (if operable, inflammatory breast cancer is excluded) 5. Her-2 non-over expressing tumor confirmed by IHC/FISH 6. Estrogen and/or progesterone receptor analysis performed on the primary tumor prior to randomization. Results must be known at the time of randomization 7. Node positive disease or node negative disease with at least one other risk factor (tumor size ? 2 cm, grade ? 2, ER and PR negative, high uPA//PAI-1 levels) 8. No evidence for distant metastasis (M0) after conventional staging 9. Performance Status ECOG ? 1 or KI ? 80 % 10. The patient must be accessible for treatment and follow-up 11. Written informed consent for shipping of tumor block for central pathology review and evaluation of Recurrence Score (HR positive) and participation in the planB trial prior to beginning specific protocol procedures, including expected cooperation of the patients for the treatment and follow-up, must be obtained and documented according to the local regulatory requirements HR positive patients must also meet all of the following clinical inclusion criteria: 12. Patient willingness to participate in adjuvant chemotherapy planB trial if RS > 11 13. Indication for chemotherapy given provided either > 4 involved lymph nodes or RS > 11 in 1-3 lymph nodes or N0 disease Additional Inclusion Criteria (Randomisation) All patients with HR negative breast cancer and patients with HR positive (ER and/or PR) tumors and node-positive disease with > 4 involved lymph nodes or 0-3 involved lymph nodes with RS > 11 will be randomized for chemotherapy question if they are meeting all of the following additional inclusion criteria prior to randomisation: 14. Laboratory requirements (within 21 days prior to randomization) 15. Negative pregnancy test (urine or serum) within 7 days prior to randomization in premenopausal patients 16. LVEF within normal limits of each institution measured by echocardiography or MUGA scan and normal ECG (within 42 days prior to randomization) Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: General Exclusion Criteria (Screening) 1. HER2 over expression confirmed by IHC/FISH/CISH 2. Known hypersensitivity reaction to the compounds or incorporated substances 3. Known polyneuropathy ? grade 2 4. Severe and relevant comorbidity that would interact with the application of cytotoxic agents or the participation in the study including acute cystitis and ischuria and chronic kidney disease. 5. Prior malignancy with a disease-free survival of 42 days
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Compare event-free survival in patients treated with either 6 cycles of Docetaxel / Cyclophosphamide chemotherapy or 4 cycles of EC followed by 4 cycles of Docetaxel as adjuvant treatment. ;Secondary Objective: Compare overall survival between the two arms Compare the toxicity between the two arms ;Primary end point(s): ·Unacceptable Toxicity ·Withdrawn Consent ·Relapse ·Second primary malignancy (with the exception of curatively treated non-melanoma skin cancer or in situ carcinoma of the cervix) ·Death ·Administration of other systemic cancer treatment other than study drug or endocrine therapy as per protocol ;Timepoint(s) of evaluation of this end point: 5 years after last patient out | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary end point(s): -comparison overal survival between the two arms -comparison of toxicity between the two arms (safety evaluation) -evaluate survival in the observation arm -perform translational research regarding prognostic and predictive sectors;Timepoint(s) of evaluation of this end point: when the data of the first 100 patients per each treatment arm are evaluable | — |
Countries
Germany
Contacts
Public ContactStudienzentrale
Westdeutsche Studiengruppe
Outcome results
None listed