Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel

Primary Breast Cancer Clinical Trial

— ETCat01  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00527449
• Other study ID #: 3305000
• 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

• Breast Neoplasms
• Primary Breast Cancer

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