Imaging for Response Assessment of Neoadjuvant Chemotherapy in Primary Breast Cancer (GALADON)
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|ClinicalTrials.gov Identifier: NCT01690325|
Recruitment Status : Terminated (Therapy of HER2+ patients according to protocol was no longer appropriate. Patient enrolment behind planned schedule and challenges of site performance)
First Posted : September 21, 2012
Last Update Posted : August 13, 2018
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Docetaxel Drug: Trastuzumab Drug: Bevacizumab Drug: Epirubicin Drug: Cyclophosphamid||Phase 2|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||21 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||Molecular Imaging for Response Assessment of Bevacizumab + Docetaxel as Neoadjuvant Chemotherapy in Primary Breast Cancer|
|Study Start Date :||September 2012|
|Actual Primary Completion Date :||November 2016|
|Actual Study Completion Date :||November 2016|
Experimental: Docetaxel, Avastin, Herceptin; adjuv. Epirubicin, Cyclophos.
Arm A: Neoadjuvant: 6 cycles of Docetaxel every 21 days together with 6 cycles of Avastin and Herceptin; Adjuvant: 4 cycles of Epirubicin and Cyclophosphamid every 21 days together with 12 cycles of Herceptin every 21 days.
Other Name: Herceptin
Other Name: Avastin
Experimental: Docetaxel, Avastin; adjuvant Epirubicin, Cyclophosphamid
Arm B: neoadjuvant: 6 cycles of Docetaxel and Avastin every 21 days. Adjuvant: 4 cycles of Epirubicin and Cyclophosphamid every 21 days.
Other Name: Avastin
- Rate of pathological complete response (pCR) following neoadjuvant therapy in group A and group B [ Time Frame: about 18 weeks (start of neoadjuvant chemotherapy until surgery) ]To determine efficacy of cytotoxic-antiangiogenic neoadjuvant therapy in primary breast cancer: bevacizumab+trastuzumab+docetaxel fro group A (HER2 positive) or bevacizumab+docetaxel for group B (HER2 negative) using pathological complete response (pCR) as the primary endpoint.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01690325
|Breast Centre, University of Munich, LMU|
|Munich, Bavaria, Germany, 81377|
|Principal Investigator:||Nadia Harbeck, Prof. Dr. med.||Head of Breast Centre, University of Munich, Grosshadern Hospital, Germany|