Clinical trial NCT00527449: Neoadjuvant Chemotherapy of Primary Breast Cancer With Epirubicin/Docetaxel and Carboplatin/Docetaxel
Official title: Neoadjuvant Chemotherapy With 3x Epirubicin/Docetaxel Followed by 3x Carboplatin/Docetaxel in Patients With Primary Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Primary Breast Cancer
Lead sponsor: Klinikum Weissenfels
Sponsor class: OTHER
First posted: 2007-09-10
Enrollment: 50
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief 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.

Detailed 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.

Eligibility criteria: 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

Primary outcomes:
measure: Determining pathologic complete remission under study treatment
timeFrame: 28 days after last administration of chemotherapy
Secondary outcomes:
measure: Rate of breast conserving operations
timeFrame: 28 days after administration of last chemotherapy
measure: Response to treatment
timeFrame: 28 days after last administration of chemotherapy
measure: Determining the therapy associated toxicity
timeFrame: 28 days after last administration of chemotherapy
Other outcomes:
Locations:
city: Halle
country: Germany
facility: Krankenhaus St. Elisabeth u. St. Barbara
state: Sachsen-Anhalt
city: Magdeburg
country: Germany
facility: Klinikum Marienstift
state: Sachsen-Anhalt
city: Weissenfels
country: Germany
facility: Asklepios Krankenhaus Weissenfels
state: Sachsen-Anhalt
Study officials:
affiliation: Asklepios Krankenhaus Weissenfels
name: Dieter Lampe, Dr. med.
role: PRINCIPAL_INVESTIGATOR
References: