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Trial Outcomes & Findings for NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer (NCT NCT01931163)

NCT ID: NCT01931163

Last Updated: 2021-07-20

Results Overview

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.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

24 participants

Primary outcome timeframe

tumor response at 12 weeks after treatment

Results posted on

2021-07-20

Participant Flow

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.

Participant milestones

Participant milestones
Measure
Everolimus Plus Cisplatin
Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
Overall Study
STARTED
22
Overall Study
COMPLETED
22
Overall Study
NOT COMPLETED
0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

NECTAR Everolimus Plus Cisplatin in Triple (-) Breast Cancer

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure
Everolimus Plus Cisplatin
n=22 Participants
Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
Age, Continuous
50.1 years
n=5 Participants
Sex: Female, Male
Female
22 Participants
n=5 Participants
Sex: Female, Male
Male
0 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Hispanic or Latino
2 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Not Hispanic or Latino
20 Participants
n=5 Participants
Ethnicity (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Race (NIH/OMB)
American Indian or Alaska Native
0 Participants
n=5 Participants
Race (NIH/OMB)
Asian
0 Participants
n=5 Participants
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
0 Participants
n=5 Participants
Race (NIH/OMB)
Black or African American
6 Participants
n=5 Participants
Race (NIH/OMB)
White
16 Participants
n=5 Participants
Race (NIH/OMB)
More than one race
0 Participants
n=5 Participants
Race (NIH/OMB)
Unknown or Not Reported
0 Participants
n=5 Participants
Region of Enrollment
United States
22 participants
n=5 Participants
TNBC patients with residual cancer >1 cm post neoadjuvant anthracycline and chemotherapy
22 Participants
n=5 Participants

PRIMARY outcome

Timeframe: tumor response at 12 weeks after treatment

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.

Outcome measures

Outcome measures
Measure
Everolimus Plus Cisplatin
n=22 Participants
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
Tumor Response
22 Participants

Adverse Events

Everolimus Plus Cisplatin

Serious events: 6 serious events
Other events: 22 other events
Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure
Everolimus Plus Cisplatin
n=22 participants at risk
Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
Blood and lymphatic system disorders
Thrombocytopenia
4.5%
1/22 • Data was collected during treatment period of 12 weeks
General disorders
Nausea
4.5%
1/22 • Data was collected during treatment period of 12 weeks
Blood and lymphatic system disorders
leucocytopenia
4.5%
1/22 • Data was collected during treatment period of 12 weeks
Eye disorders
papilledema
4.5%
1/22 • Data was collected during treatment period of 12 weeks
Blood and lymphatic system disorders
neutropenia
4.5%
1/22 • Data was collected during treatment period of 12 weeks
Metabolism and nutrition disorders
hyperglycemia
4.5%
1/22 • Data was collected during treatment period of 12 weeks

Other adverse events

Other adverse events
Measure
Everolimus Plus Cisplatin
n=22 participants at risk
Cisplatin 20 mg/m2 IV infusion over 60 minutes, weekly (Days 1, 8, 15) x 4 cycles Everolimus 10mg by mouth daily
General disorders
Nausea
40.9%
9/22 • Data was collected during treatment period of 12 weeks
General disorders
Fatigue
45.5%
10/22 • Data was collected during treatment period of 12 weeks
General disorders
Mucositis
22.7%
5/22 • Data was collected during treatment period of 12 weeks

Additional Information

Dr. Jenny Chang

The Methodist Hospital Research Institute

Phone: 713 441-0680

Results disclosure agreements

  • Principal investigator is a sponsor employee
  • Publication restrictions are in place