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Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

Phase 3
18 Years
75 Years
Open (Enrolling)
Primary Breast Cancer, Her2 Non-overexpressing

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Trial Information

Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer

Inclusion Criteria

Inclusion Criteria(Screening):

- Female patients, age at diagnosis 18 - 75 years

- Histological confirmed unilateral primary invasive carcinoma of the breast

- Adequate surgical treatment with complete resection of the tumor (R0) and resection
of > or = 10 axillary nodes or SLN in clinically N0 patients

- T1 - T4 (if operable, inflammatory breast cancer is excluded)

- Her-2 non-over expressing tumor confirmed by IHC/FISH

- Estrogen and/or progesterone receptor analysis performed on the primary tumor prior
to randomization. Results must be known at the time of randomization

- Node positive disease or node negative disease with at least one other risk factor
(tumor size > or = 2 cm, grade > or = 2, ER and PR negative, high uPA//PAI-1 levels)

- No evidence for distant metastasis (M0) after conventional staging

- Performance Status ECOG < or = 1 or KI > or = 80 %

- The patient must be accessible for treatment and follow-up

- Written informed consent for central pathology review and evaluation of Recurrence
Score (HR positive) and participation in the planB trial prior to beginning specific
protocol procedures

HR positive patients:

- Patient willingness to participate in adjuvant chemotherapy planB trial if RS > 11

- 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 to chemotherapy):

- Laboratory requirements (within 21 days prior to randomization):

- Leucocytes > or = 3.5 109/L

- platelets > or = 100 109/L

- haemoglobin > or = 10 g/dL

- total bilirubin < or = 1 ULN

- ASAT (SGOT) and ALAT (SGPT) < or = 2.5 UNL

- creatinine < 175 ymol/L (2 mg/dL)

- Negative pregnancy test (urine or serum) within 7 days prior to randomization in
premenopausal patients

- LVEF within normal limits of each institution measured by echocardiography or MUGA
scan and

Exclusion Criteria(Screening):

- HER2 over expression confirmed by IHC/FISH/CISH

- Known hypersensitivity reaction to the compounds or incorporated substances

- Known polyneuropathy > or = grade 2

- 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.

- Prior malignancy with a disease-free survival of < 10 years, except curatively
treated basalioma of the skin, pTis of the cervix uteri or ipsilateral ductal
carcinoma in-situ (DCISpTis of the breast)

- Non-operable breast cancer including inflammatory breast cancer

- Previous or concurrent treatment with cytotoxic agents for any reason after
consultation with the sponsor

- Concurrent treatment with other experimental drugs. Participation in another clinical
trial with any investigational not marketed drug within 30 days prior to study entry

- Male breast cancer

- Concurrent pregnancy; patients of childbearing potential must implement a highly
effective (less then 1% failure rate) non-hormonal contraceptive measures during the
study treatment

- Breast feeding woman

- Sequential breast cancer

- Lack of patient compliance

Additional Exclusion Criteria (Randomisation):

- Inadequate organ function including:

- Leucocytes < 3,5 G/l

- platelets < 100 G/l

- creatinine or bilirubin above normal limits

- alkaline phosphatise > 5 UNL

- ASAT and/or ALAT associated with AP > 2.5 UNL

- uncompensated cardiac function

- Time since axillary dissection > 42 days

Type of Study:


Study Design:

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

disease-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

Outcome Time Frame:

5 years

Safety Issue:


Principal Investigator

Ulrike A. Nitz, Prof. Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Ev. Krankenhaus Bethesda Moenchengladbach


Germany: Federal Institute for Drugs and Medical Devices

Study ID:




Start Date:

January 2009

Completion Date:

Related Keywords:

  • Primary Breast Cancer
  • Her2 Non-overexpressing
  • anthracycline-free
  • OncotypDX
  • taxane
  • Her2 negative breast cancer
  • Breast Neoplasms