Neoadjuvant Chemotherapy Docetaxel With or Without SELUMETINIB in Patients With Triple Negative Breast Cancer
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|ClinicalTrials.gov Identifier: NCT02685657|
Recruitment Status : Unknown
Verified February 2016 by Mona Frolova, Russian Academy of Medical Sciences.
Recruitment status was: Not yet recruiting
First Posted : February 19, 2016
Last Update Posted : February 22, 2016
|Condition or disease||Intervention/treatment||Phase|
|Triple Negative Breast Cancer||Drug: Drug: Selumetinib Drug: Doxorubicin Drug: Cyclophosphamide Drug: Docetaxel||Phase 2|
Molecular analysis of residual tumor after administration of neoadjuvant chemotherapy revealed several mechanisms of resistance to treatment. High frequency of RAS-RAF-MEK-ERK signal pathway activation was found in cells of triple negative breast cancer after neoadjuvant chemotherapy, which correlated with high proliferation index and low pathological complete response rate. Thus, inhibition of MEK molecule - an intermediary transducer of this pathway may decrease activity of this pathway and restore tumor sensitivity to cytostatic agents.
Hence, the use of SELUMETINIB, an oral selective inhibitor of MEK1/MEK2 kinases, in combination with Docetaxel should increase pathological complete response rate and in turn increase survival of patients with early and locally advanced triple-negative breast cancer.
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||164 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Phase II Randomized Multicenter Open Label Prospective Study of Neoadjuvant Chemotherapy Docetaxel With or Without MEK Inhibitor SELUMETINIB in Patients With Early and Locally Advanced Triple Negative Breast Cancer|
|Study Start Date :||September 2016|
|Estimated Primary Completion Date :||January 2018|
Experimental: AC followed by Docetaxel with Selumetinib
Doxorubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 as a single IV infusion on day 1 of every 3 week cycle then 75 mg/m2 of Docetaxel given as a single IV infusion on day 1 of every 3 week cycle, 75 mg of SELUMETINIB twice a day PO on days 1-21 of every 3 week cycle
Drug: Drug: Selumetinib
Other Name: AZD6244
Active Comparator: AC followed by Docetaxel
Doxorubicin 60 mg/m2 and Cyclophosphamide 600 mg/m2 as a single IV infusion on day 1 of every 3 week cycle then 75 mg/m2 of Docetaxel given as a single IV infusion on day 1 of every 3 week cycle
- • Pathological complete response rate [ Time Frame: After 24 weeks of neoadjuvant chemotherapy and surgery ]
- • Overall clinical response rate [ Time Frame: After 24 weeks of neoadjuvant chemotherapy ]
- • Adverse events rate in both treatment groups [ Time Frame: After 24 weeks of neoadjuvant chemotherapy ]
- Association between RAS-ERK signal pathway activity in tumor and pathological complete response rate in patients who were receiving or not receiving SELUMETINIB [ Time Frame: After 24 weeks of neoadjuvant chemotherapy ]
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): NCT02685657
|Contact: Mona Frolovafirstname.lastname@example.org|
|Principal Investigator:||Mona Frolova||Russian Cancer Research Center|