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Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Female
Primary Breast Cancer

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Trial Information

Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer


Most of the women who are diagnosed with breast cancer are in the situation that an
operation is possible. Using a neoadjuvant therapy the rate of breast-conserving surgery can
be extended and tumor cell proliferation may be inhibited. Further the neoadjuvant
chemotherapy is an in-vivo-activity-test for the used drugs. Epirubicin, Docetaxel and
Carboplatin have shown antineoplastic activity against solid cancer alone and in
combination.

Using two different combinations of these three drugs, first 3 cycles Epirubicin/Docetaxel
and then changing to Carboplatin/Docetaxel for 3 further cycles it is assumed that the
results of the therapy will improve. Main criterion is the determination of pCR, second
criteria are the rate of breast-conserving surgery, tumor response and therapy-dependent
toxicities.


Inclusion Criteria:



- histologically assured breast cancer

- age >= 18 years

- bone marrow function: neutrophils >= 1.5x109/l, platelets >= 100x109/l,
hemoglobin >=6.2 mmol/l

- sufficient renal and liver function

- ECOG 0-2

- written informed consent

Exclusion Criteria:

- pregnant or nursing women

- distant metastases

- T2-Tumour < 3cm and G1

- existing motoric or sensoric neurotoxicity > Grade 2

- known hypersensitivity against Epirubicin or other anthracycline or against
Carboplatin or other platin derivatives or against Docetaxel or against substances in
the preparing solutions

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Determining pathologic complete remission under study treatment

Outcome Time Frame:

28 days after last administration of chemotherapy

Safety Issue:

No

Principal Investigator

Dieter Lampe, Dr. med.

Investigator Role:

Principal Investigator

Investigator Affiliation:

Asklepios Krankenhaus Weissenfels

Authority:

Germany: Federal Institute for Drugs and Medical Devices

Study ID:

3305000

NCT ID:

NCT00527449

Start Date:

May 2006

Completion Date:

September 2008

Related Keywords:

  • Primary Breast Cancer
  • Breast Neoplasms

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