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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00527449
Other study ID # 3305000
Secondary ID
Status Completed
Phase Phase 2
First received September 7, 2007
Last updated January 14, 2010
Start date May 2006
Est. completion date September 2008

Study information

Verified date January 2010
Source Klinikum Weissenfels
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Interventional

Clinical Trial Summary

The purpose of this study is to optimize results in neoadjuvant chemotherapy of local advanced primary breast cancer. Therefore patients become first 3 cycles of Epirubicin/Docetaxel followed by 3x Carboplatin/Docetaxel.


Description:

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.


Recruitment information / eligibility

Status Completed
Enrollment 50
Est. completion date September 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Female
Age group 18 Years and older
Eligibility 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

Study Design

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


Related Conditions & MeSH terms


Intervention

Drug:
Epirubicin, Carboplatin, Docetaxel
75 mg/m² Docetaxel (60 minutes i.v.) and 90 mg/m² Epirubicin (10-15 min i.v.) on day 1, 22, 42. After these 3 cycles 75 mg/m² Docetaxel (60 minutes i.v.) and Carboplatin AUC 5 (30 min i. v.) on day 63, 84, 105.

Locations

Country Name City State
Germany Krankenhaus St. Elisabeth u. St. Barbara Halle Sachsen-Anhalt
Germany Klinikum Marienstift Magdeburg Sachsen-Anhalt
Germany Asklepios Krankenhaus Weissenfels Weissenfels Sachsen-Anhalt

Sponsors (1)

Lead Sponsor Collaborator
Klinikum Weissenfels

Country where clinical trial is conducted

Germany, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determining pathologic complete remission under study treatment 28 days after last administration of chemotherapy No
Secondary Rate of breast conserving operations 28 days after administration of last chemotherapy No
Secondary Response to treatment 28 days after last administration of chemotherapy No
Secondary Determining the therapy associated toxicity 28 days after last administration of chemotherapy Yes
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