NOV-002, Doxorubicin, Cyclophosphamide, and Docetaxel in Women With Newly Diagnosed Stage II or IIIC Breast Cancer
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|ClinicalTrials.gov Identifier: NCT00499122|
Recruitment Status : Completed
First Posted : July 11, 2007
Results First Posted : March 29, 2013
Last Update Posted : January 2, 2018
RATIONALE: Oxidized glutathione (NOV-002) may stimulate the immune system in different ways and stop tumor cells from growing. Drugs used in chemotherapy, such as doxorubicin, cyclophosphamide, and docetaxel, work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Giving more than one drug (combination chemotherapy) may kill more tumor cells. Giving NOV-002 together with chemotherapy before surgery may make the tumor smaller and reduce the amount of normal tissue that needs to be removed.
PURPOSE: This phase II trial is studying how well giving oxidized glutathione (NOV-002) together with doxorubicin and cyclophosphamide followed by docetaxel works in treating women with newly diagnosed stage II or stage III breast cancer.
|Condition or disease||Intervention/treatment||Phase|
|Breast Cancer||Drug: Cyclophosphamide Drug: Docetaxel Drug: Doxorubicin Drug: NOV 002||Phase 2|
OUTLINE: This is a multicenter study.
Patients receive oxidized glutathione (NOV-002) IV twice on day -1 of course 1 and once on day 1 of courses 2-8. Patients receive NOV-002 subcutaneously once daily on days 2-21 of courses 1-8. Patients also receive chemotherapy comprising doxorubicin hydrochloride IV and cyclophosphamide IV on day 1 of courses 1-4 followed by docetaxel IV on day 1 of courses 5-8. Treatment repeats every 21 days in the absence of disease progression or unacceptable toxicity.
Patients undergo definitive surgery 3-6 weeks after completion of neoadjuvant therapy.
Blood samples are obtained at baseline and periodically during study to measure serum and plasma protein glutathionlylation. Additional blood samples are collected from some patients for immunological correlative studies.
After completion of study therapy, patients are followed at 30 days.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||41 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Phase II Study of Neoadjuvant Treatment With NOV-002 in Combination With Doxorubicin and Cyclophosphamide Followed by Docetaxel in Patients With Stages IIB-IIIC Breast Cancer|
|Actual Study Start Date :||June 4, 2007|
|Primary Completion Date :||April 2011|
|Study Completion Date :||April 2011|
Experimental: NOV-002 and Chemotherapy
Other Name: CytoxanDrug: Docetaxel
Other Name: CytoxanDrug: Doxorubicin
Other Name: AdriamycinDrug: NOV 002
Other Name: Oxidized glutathione
- Rate of Pathologic Complete Response in the Affected Breast After Protocol Therapy [ Time Frame: About 7 months ]The primary objective of this study is to define the rate of pathologic complete response rate (pCR) in the affected breast after the preoperative administration of NOV-002 in combination with doxorubicin and cyclophosphamide followed by docetaxel in patients with stage IIB-IIIC breast cancer. Pathologic complete response (pCR) is defined according to Hankoop et al  as either: the absence of any histological evidence of invasive breast cancer cells in the tissue specimen removed from the breast or the presence of invasive tumor equal to or less than 10mm after preoperative treatment, determined at definitive breast surgery.
- Definition of the Safety Profiles of Protocol Therapy [ Time Frame: Up to 30 days Post-Last Dose of Protocol Therapy, About 7 months ]Definition of the safety profiles of protocol therapy in study participants as shown by the number of study participants experiencing adverse events or other toxicity.
- Correlation Between Myeloid Derived Suppressor Cell (MDSC) Levels and Pathologic Complete Response (pCR) and Non-Responders [ Time Frame: Baseline, Day 1 of Cycles 1 through 8, about 7 months ]The investigators hypothesized that patients with favorable responses, i.e. pCR, are more likely to have significantly lower levels of MDSCs than non-responders. MDSC levels will be measured at baseline and on day 1 of each treatment cycle, cycles 1 through 8.
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): NCT00499122
|United States, Florida|
|University of Miami|
|Miami, Florida, United States, 33136|
|United States, South Carolina|
|Hollings Cancer Center at Medical University of South Carolina|
|Charleston, South Carolina, United States, 29425|
|Study Chair:||Keisuke Shirai, MD||Medical University of South Carolina|
|Principal Investigator:||Alberto Montero, MD||University of Miami|