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Anthracycline-free Taxane Based Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer (planB)

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ClinicalTrials.gov Identifier: NCT01049425
Recruitment Status : Unknown
Verified June 2015 by West German Study Group.
Recruitment status was:  Active, not recruiting
First Posted : January 14, 2010
Last Update Posted : June 19, 2015
Sponsor:
Collaborators:
Sanofi
Amgen
Information provided by (Responsible Party):
West German Study Group

Brief Summary:

The planned trial compares an anthracycline-free taxane based regimen versus a modern third generation (anthracycline/taxane-based) regimen in HER2/neu non-over expressing tumors. The aim is to define a further anthracycline-free standard and to spare anthracycline toxicity to a patient, who will only have a modest benefit from this compound. Prior to randomization for chemotherapy for all patients with HR positive disease OncotypeDX® will be performed to identify patients who should not receive chemotherapy.

Secondary objectives of this trial will be to compare overall survival and toxicity between the two chemotherapy arms, to evaluate survival in the observation arm and to perform translational research regarding prognostic and predictive factors.


Condition or disease Intervention/treatment Phase
Primary Breast Cancer Her2 Non-overexpressing Drug: Epirubicin Drug: Cyclophosphamide Drug: Docetaxel Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2448 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Randomised Comparison of Adjuvant Docetaxel / Cyclophosphamide With Sequential Adjuvant EC / Docetaxel Chemotherapy in Patients With HER2/Neu Negative Early Breast Cancer
Study Start Date : January 2009
Actual Primary Completion Date : July 2011
Estimated Study Completion Date : December 2016

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Breast Cancer

Arm Intervention/treatment
Active Comparator: Epirubicin and Cyclophosphamid followed by Docetaxel
4 cycles of EC on day one every three weeks followed by 4 cycles of Docetaxel on day one every three weeks
Drug: Epirubicin
4 cycles, intravenous use, day 1 every three weeks

Drug: Cyclophosphamide
4 cycles, intravenous infusion, day 1 every three weeks

Drug: Docetaxel
4 cycles, intravenous infusion, day 1 every three weeks after completion of EC-chemotherapy

Experimental: Combination of Docetaxel and Cyclophosphamid
intravenous infusion on day one every three weeks
Drug: Cyclophosphamide
6 cycles, intravenous infusion, day 1 every 3 weeks

Drug: Docetaxel
6 cycles, intravenous infusion, day one every three weeks




Primary Outcome Measures :
  1. 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 [ Time Frame: 5 years ]


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Ages Eligible for Study:   18 Years to 75 Years   (Adult, Older Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   No
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01049425


Locations
Germany
Bethesda Krankenhaus
Moenchengladbach, Germany, 41061
Sponsors and Collaborators
West German Study Group
Sanofi
Amgen
Investigators
Principal Investigator: Ulrike A. Nitz, Prof. Dr. med. Ev. Krankenhaus Bethesda Moenchengladbach
Study Chair: Nadia Harbeck, Prof. Dr. med. University Hospital Cologne

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: West German Study Group
ClinicalTrials.gov Identifier: NCT01049425     History of Changes
Other Study ID Numbers: WSG AM04
First Posted: January 14, 2010    Key Record Dates
Last Update Posted: June 19, 2015
Last Verified: June 2015

Keywords provided by West German Study Group:
anthracycline-free
OncotypDX
taxane
Her2 negative breast cancer

Additional relevant MeSH terms:
Breast Neoplasms
Neoplasms by Site
Neoplasms
Breast Diseases
Skin Diseases
Cyclophosphamide
Docetaxel
Epirubicin
Immunosuppressive Agents
Immunologic Factors
Physiological Effects of Drugs
Antirheumatic Agents
Antineoplastic Agents, Alkylating
Alkylating Agents
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Myeloablative Agonists
Tubulin Modulators
Antimitotic Agents
Mitosis Modulators
Antibiotics, Antineoplastic
Topoisomerase II Inhibitors
Topoisomerase Inhibitors
Enzyme Inhibitors