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NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer (NECTAR)

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ClinicalTrials.gov Identifier: NCT01931163
Recruitment Status : Completed
First Posted : August 29, 2013
Results First Posted : July 9, 2021
Last Update Posted : July 20, 2021
Sponsor:
Collaborator:
The Methodist Hospital Research Institute
Information provided by (Responsible Party):
Jenny C. Chang, MD, The Methodist Hospital Research Institute

Study Type Interventional
Study Design Allocation: N/A;   Intervention Model: Single Group Assignment;   Masking: None (Open Label);   Primary Purpose: Treatment
Conditions Breast Cancer
Triple Negative Breast Cancer
Intervention Drug: Everolimus
Enrollment 24
Recruitment Details

24 patients with Stage II/III Triple Negative Breast Cancer with residual cancer >1cm post-neoadjuvant anthracycline and taxane-based chemotherapy were enrolled.

Of the 24 patients, 2 were excluded (one because of metastasis before treatment and one because of withdrawal); 22 were included in the efficacy analysis.

Pre-assignment Details  
Arm/Group Title Everolimus Plus Cisplatin
Hide Arm/Group Description Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
Period Title: Overall Study
Started 22
Completed 22
Not Completed 0
Arm/Group Title Everolimus Plus Cisplatin
Hide Arm/Group Description Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
Overall Number of Baseline Participants 22
Hide Baseline Analysis Population Description
[Not Specified]
Age, Continuous  
Median (Full Range)
Unit of measure:  Years
Number Analyzed 22 participants
50.1
(31.9 to 74.4)
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Female
22
 100.0%
Male
0
   0.0%
Ethnicity (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
Hispanic or Latino
2
   9.1%
Not Hispanic or Latino
20
  90.9%
Unknown or Not Reported
0
   0.0%
Race (NIH/OMB)  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
American Indian or Alaska Native
0
   0.0%
Asian
0
   0.0%
Native Hawaiian or Other Pacific Islander
0
   0.0%
Black or African American
6
  27.3%
White
16
  72.7%
More than one race
0
   0.0%
Unknown or Not Reported
0
   0.0%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
United States Number Analyzed 22 participants
22
TNBC patients with residual cancer >1 cm post neoadjuvant anthracycline and chemotherapy  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 22 participants
22
 100.0%
1.Primary Outcome
Title Tumor Response
Hide Description

Evaluate tumor response using RECIST criteria after 12 weeks of treatment at definitive surgery.

Per Response Evaluation Criteria In Solid Tumors Criteria (RECIST v1.0) for target lesions and assessed by MRI: Complete Response (CR), Disappearance of all target lesions; Partial Response (PR), >=30% decrease in the sum of the longest diameter of target lesions; Overall Response (OR) = CR + PR.", or similar definition that is accurate and appropriate.

Time Frame tumor response at 12 weeks after treatment
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title Everolimus Plus Cisplatin
Hide Arm/Group Description:
Everolimus 10mg by mouth daily for 12 weeks; Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles
Overall Number of Participants Analyzed 22
Measure Type: Count of Participants
Unit of Measure: Participants
22
 100.0%
Time Frame Data was collected during treatment period of 12 weeks
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title Everolimus Plus Cisplatin
Hide Arm/Group Description Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
All-Cause Mortality
Everolimus Plus Cisplatin
Affected / at Risk (%)
Total   0/22 (0.00%) 
Hide Serious Adverse Events
Everolimus Plus Cisplatin
Affected / at Risk (%)
Total   6/22 (27.27%) 
Blood and lymphatic system disorders   
Thrombocytopenia   1/22 (4.55%) 
leucocytopenia   1/22 (4.55%) 
neutropenia   1/22 (4.55%) 
Eye disorders   
papilledema   1/22 (4.55%) 
General disorders   
Nausea   1/22 (4.55%) 
Metabolism and nutrition disorders   
hyperglycemia   1/22 (4.55%) 
Indicates events were collected by systematic assessment
Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 5%
Everolimus Plus Cisplatin
Affected / at Risk (%)
Total   22/22 (100.00%) 
General disorders   
Nausea   9/22 (40.91%) 
Fatigue   10/22 (45.45%) 
Mucositis   5/22 (22.73%) 
Indicates events were collected by systematic assessment
Certain Agreements
All Principal Investigators ARE employed by the organization sponsoring the study.
Results Point of Contact
Layout table for Results Point of Contact information
Name/Title: Dr. Jenny Chang
Organization: The Methodist Hospital Research Institute
Phone: 713 441-0680
EMail: jcchang@houstonmethodist.org
Layout table for additonal information
Responsible Party: Jenny C. Chang, MD, The Methodist Hospital Research Institute
ClinicalTrials.gov Identifier: NCT01931163    
Other Study ID Numbers: Pro00008952
IRB(2)#0513-0062 ( Other Identifier: TMHRI IRB )
CRAD001 JUST213 ( Other Identifier: Other ID )
First Submitted: August 26, 2013
First Posted: August 29, 2013
Results First Submitted: April 27, 2021
Results First Posted: July 9, 2021
Last Update Posted: July 20, 2021