Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00003637

Trial Description

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Title

An Investigational Randomized Study on Epirubicin Plus Cyclophospamide (EC) or Cyclophosphamide Plus Methotrexat Plus 5-fluorouracil (CMF) Versus Nab-paclitaxel Plus Capecitabine as Adjuvant Chemotherapy for Elderly Non Frail Patients With an Increased Risk for Relapse of a Primary Carcinoma of the Breast

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Trial Acronym

ICE II

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URL of the Trial

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Brief Summary in Lay Language

Although approximately 50% of new diagnosis breast cancers are in patients above the age of
65, elderly people remain substantially under-represented in clinical trials, and therefore
are under-treated. A recent trial of the CALBG in patient's ≥ 65 years with medium risk of
breast cancer demonstrated an improved disease-free and overall survival for those treated
with AC or CMF compared to those treated with capecitabine alone.

The primary aim of the ICE II trial is to determine the compliance and toxicity of
epirubicin plus cyclophosphamide (EC) or CMF versus nab-paclitaxel plus capecitabine as
adjuvant therapy in non frail elderly patients.

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Brief Summary in Scientific Language

Primary Objective:

Phase II:

To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF (EC/CMF)
and nab-paclitaxel in combination with capecitabine (PX).

Secondary Objective(s):

1. To compare the disease-free survival (DFS) and distant disease free survival (DDFS)
with epirubicin plus cyclophosphamide or CMF (EC/CMF) vs. nab-paclitaxel in combination
with capecitabine (PX).

2. To compare the overall survival (OS) with epirubicin plus cyclophosphamide or CMF
(EC/CMF) vs nab-paclitaxel in combination with capecitabine (PX).

3. To analyze the efficacy of treatments in subgroups according to clinical stratification
factors.

4. To determine prognostic factors on tumor tissue collected from primary surgery and to
correlate them with study treatment effect.

5. To compare the geriatric assessments scores (Charlson, VES-13, IADL, G8) at baseline
and end of therapy.

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Organizational Data

  •   DRKS00003637
  •   2012/05/04
  •   2010/09/10
  •   yes
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Secondary IDs

  •   2008-003995-23 
  •   NCT01204437  (ClinicalTrials.gov)
  •   GBG 52  (German Breast Group)
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Health Condition or Problem studied

  •   Breast Cancer
  •   C50 -  Malignant neoplasm of breast
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Interventions/Observational Groups

  •   Drug: Epirubicin, Cyclophosphamide
  •   Drug: Cyclophosphamide, Methotrexate, 5 FU
  •   Drug: Capecitabine, Nab-Paclitaxel
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Characteristics

  •   Interventional
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  •   Randomized controlled trial
  •   Open (masking not used)
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  •   Active control (effective treament of control group)
  •   Treatment
  •   Parallel
  •   II-III
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Primary Outcome

- To determine the compliance and safety of epirubicin plus cyclophosphamide or CMF (EC/CMF) and nab-paclitaxel in combination with capecitabine (PX).; time frame: 4 months after Last Patient Out

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Secondary Outcome

- To compare the disease-free survival (DFS) and distant disease free survival (DDFS) with epirubicin plus cyclophosphamide or CMF (EC/CMF) vs. nab-paclitaxel in combination with capecitabine (PX).; time frame: After 4.5 years of Follow Up
- To compare the overall survival (OS) with epirubicin plus cyclophosphamide or CMF (EC/CMF) vs nab-paclitaxel in combination with capecitabine (PX).; time frame: After 4.5 years of Follow Up
- To analyze the efficacy of treatments in subgroups according to clinical stratification factors.; time frame: After 4.5 years of Follow Up
- To determine prognostic factors on tumor tissue collected from primary surgery and to correlate them with study treatment effect.; time frame: After 4.5 years of Follow Up
- To compare the geriatric assessment scores (Charlson, VES-13, IADL, G8) at baseline and end of therapy; time frame: 4 months after Last Patient Out

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Countries of Recruitment

  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2009/03/31
  •   400
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Inclusion Criteria

  •   Both, male and female
  •   65   Years
  •   no maximum age
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Additional Inclusion Criteria

1. Written informed consent for all study procedures must be obtained and documented
according to local regulatory requirements prior to beginning specific protocol
procedures.

2. Complete baseline documentation must be sent to GBG Forschungs GmbH.

3. Histological confirmed unilateral or bilateral primary carcinoma of the breast.

4. Female and male breast cancer patients with age at first histologically diagnosis and
axilla dissection ≥ 65 years.

5. Adequate surgical treatment with complete resection (R0) of the tumor and ≥ 10
axillary nodes. Sole sentinel node biopsy is allowed if the sentinel node shows no
tumor involvement.

6. No evidence for distant metastasis at bone scan, liver ultrasound and chest x-ray.

7. Patients with stage pT3/4 or pN2/3 (≥ 4 involved lymph nodes) irrespective of
additional risk factors.

8. Patients with stage pT1/2 and pN0/1 (0-3 involved lymph nodes) with an increased risk
according to the clinico-pathological or uPA/PAI-1 criteria.

9. ECOG Performance Status <= 2.

10. Charlson Scale <= 2.

11. Estimated life expectancy of at least 5 years (irrespective of breast cancer
diagnosis).

12. The patient must be accessible for treatment and follow-up. Patients registered on
this trial must be treated and followed at the participating centre which could be
the Principal or a Co- investigator's site.

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Exclusion Criteria

1. Known hypersensitivity reaction to the compounds or incorporated substances or known
dihydropyrimidine dehydrogenase deficiency.

2. Low risk patient according to risk assessment.

3. Inadequate organ function including:

Leucocytes < 3,5 G/l, Platelets < 100 G/l , Creatinine or Bilirubin above normal
limits (1,25 above upper normal limit), Creatinine-Clearance below 50 ml/min,
uncompensated cardiac function, severe and relevant co-morbidity that would interact
with the application of cytotoxic agents or the participation in the study.

4. Previously or currently one of the following medical conditions:

- pre-existing motor or sensory neuropathy of a severity >= grade 2 by NCI-CTC
criteria;

- history of significant neurological or psychiatric disorders including psychotic
disorders, dementia or seizures that would prohibit the understanding and giving
of informed consent;

- known or suspected congestive heart failure (> NYHA I) and/or coronary heart
disease, angina pectoris requiring antianginal medication, previous history of
myocardial infarction, evidence of transmural infarction on ECG, un- or poorly
controlled arterial hypertension (i.e. BP >150/100 mmHg under treatment with two
antihypertensive drugs), rhythm abnormalities requiring permanent treatment,
clinically significant valvular heart disease;

- Creatinine Clearance less than 50 ml/min;

- another primary malignancy with an event-free survival of < 5 years, except
curatively treated basalioma of the skin and carcinoma in situ of the cervix.

5. Time since axillary dissection > 3 months.

6. Locally advanced, non-operable breast cancer.

7. Previous invasive breast carcinoma.

8. Prior chemotherapy for any malignancy.

9. Concurrent specific systemic anti-tumor treatment or treatment with experimental
compounds within the last 6 months.

10. Concurrent treatment with other tumor specific experimental drugs. Participation in
another clinical trial with any investigational not marketed drug.

11. Concurrent treatment with virostatic agents like sorivudine or analogues like
brivudine, concurrent treatment with aminoglycosides, anticoagulants: heparin,
warfarin as well as acetylic acid (e.g. Aspirin®) at a dose of > 325mg/day or
clopidogrel at a dose of > 75 mg/day).

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Addresses

  • start of 1:1-Block address primary-sponsor
    • German Breast Group
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    •   [---]*
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    • German Breast Group
    • Gunter von Minckwitz, Prof. Dr. med. 
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    •   [---]*
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    • German Breast Group
    • Gunter von Minckwitz, Prof. Dr. med. 
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    •   [---]*
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Sources of Monetary or Material Support

  • start of 1:1-Block address materialSupport
    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting complete, follow-up continuing
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   7
  •   2013/10/20
* This entry means the parameter is not applicable or has not been set.