Trial Outcomes & Findings for Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer (NCT NCT01959490)

NCT ID: NCT01959490

Last Updated: 2019-03-05

Results Overview

Number of patients with a pathological complete response (pCR) who received targeted therapy with trastuzumab and pertuzumab or bevacizumab predicted by genomically-derived molecular subtypes (HER2 positive or HER2 negative. pCR is defined as absence of invasive cancer in breast or lymph nodes after neoadjuvant chemotherapy.

Recruitment status

COMPLETED

Study phase

PHASE2

Target enrollment

16 participants

Primary outcome timeframe

Up to 30 days after last cycle of treatment

Results posted on

2019-03-05

Participant Flow

Participant milestones

Participant milestones
Measure	Cohort 1P (HER2 Positive) Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort 1T (HER2 Positive) Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort II (HER2 Negative) Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.
Overall Study STARTED	5	6	5
Overall Study COMPLETED	5	6	5
Overall Study NOT COMPLETED	0	0	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

Trastuzumab and Pertuzumab or Bevacizumab With Combination Chemotherapy in Treating Patients With Stage II-III Breast Cancer

Baseline characteristics by cohort

PRIMARY outcome

Timeframe: Up to 30 days after last cycle of treatment

Population: All participants enrolled in study and who received treatment.

Outcome measures

Outcome measures
Measure	Cohort 1P (HER2 Positive) n=5 Participants Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort 1T (HER2 Positive) n=6 Participants Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort II (HER2 Negative) n=5 Participants Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.
Number of Patients With a Pathological Complete Response (pCR) Who Received Targeted Therapy With Trastuzumab and Pertuzumab or Bevacizumab Predicted by Genomically-derived Molecular Subtypes.	4 Participants	6 Participants	3 Participants

SECONDARY outcome

Timeframe: Up to 30 days after last cycle of treatment

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after last cycle of treatment

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after last cycle of treatment

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: Up to 30 days after last cycle of treatment

Population: Data not collected

Outcome measures

Outcome data not reported

SECONDARY outcome

Timeframe: At 2 weeks after start of run-in period

Population: Data not collected

Determine if changes in regularity and entropy range predict pCR and in an exploratory fashion determine if specific texture features exist in each molecular subtype that predict pCR.

Outcome measures

Outcome data not reported

OTHER_PRE_SPECIFIED outcome

Timeframe: Up to 30 days after last cycle of treatment

Population: Outcome not determined because low accrual prevented appropriate analysis and calculation of the prediction measure.

Qualitative and quantitative image analysis will be performed and descriptively summarized. For the 10 patients in the PET/CT sub-study of cohort 1.

Outcome measures

Outcome data not reported

Adverse Events

Cohort 1P (HER2 Positive)

Serious events: 1 serious events

Other events: 5 other events

Deaths: 0 deaths

Cohort 1T (HER2 Positive)

Serious events: 0 serious events

Other events: 3 other events

Deaths: 0 deaths

Cohort II (HER2 Negative)

Serious events: 1 serious events

Other events: 4 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Cohort 1P (HER2 Positive) n=5 participants at risk Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort 1T (HER2 Positive) n=6 participants at risk Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort II (HER2 Negative) n=5 participants at risk Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.
Blood and lymphatic system disorders Anemia	0.00% 0/5 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment
Gastrointestinal disorders Diarrhea	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Blood and lymphatic system disorders Febrile neutropenia	0.00% 0/5 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment
Vascular disorders Hypotension	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Investigations Neutrophil count decreased	0.00% 0/5 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment
Nervous system disorders Syncope	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Investigations White blood cell decreased	0.00% 0/5 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment

Other adverse events

Other adverse events
Measure	Cohort 1P (HER2 Positive) n=5 participants at risk Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort 1T (HER2 Positive) n=6 participants at risk Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort II (HER2 Negative) n=5 participants at risk Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.
Blood and lymphatic system disorders Anemia	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Ear and labyrinth disorders Hearing impaired	0.00% 0/5 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment
Vascular disorders Hypertension	40.0% 2/5 • Number of events 8 • Up to 30 days after last cycle of treatment	50.0% 3/6 • Number of events 6 • Up to 30 days after last cycle of treatment	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment
Metabolism and nutrition disorders Hypokalemia	0.00% 0/5 • Up to 30 days after last cycle of treatment	16.7% 1/6 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Investigations Lymphocyte count decreased	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	33.3% 2/6 • Number of events 2 • Up to 30 days after last cycle of treatment	40.0% 2/5 • Number of events 7 • Up to 30 days after last cycle of treatment
Investigations Neutrophil count decreased	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment
Cardiac disorders Sinus tachycardia	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Infections and infestations Urinary tract infection	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Cardiac disorders Ventricular tachycardia	0.00% 0/5 • Up to 30 days after last cycle of treatment	16.7% 1/6 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Investigations Weight loss	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	0.00% 0/5 • Up to 30 days after last cycle of treatment
Investigations White blood cell decreased	20.0% 1/5 • Number of events 1 • Up to 30 days after last cycle of treatment	0.00% 0/6 • Up to 30 days after last cycle of treatment	60.0% 3/5 • Number of events 4 • Up to 30 days after last cycle of treatment

Additional Information

Dr. Paula Silverman

Cleveland Medical Center, University Hospitals Seidman Cancer Center, Case Comprehensive Cancer Center

Phone: 1-800-641-2422

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place

Measure	Cohort 1P (HER2 Positive) n=5 Participants Patients receive a run-in Pertuzumab treatment of 840 mg IV over 60 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, docetaxel IV, and carboplatin IV on day 1. Treatment repeats very 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity	Cohort 1T (HER2 Positive) n=6 Participants Patients receive a run-in Trastuzumab treatment of 8 mg/kg IV over 90 minutes on day -14 followed by Trastuzumab IV over 30-60 minutes and Pertuzumab IV over 30-60 minutes, Docetaxel IV, and Carboplatin IV on day 1. Treatment repeats every 3 weeks for 6 courses in the absence of disease progression or unacceptable toxicity.	Cohort II (HER2 Negative) n=5 Participants Patients receive Bevacizumab IV over 30-60 minutes on day 1 of weeks 1, 3, 5, 7, 9, and 11; Doxorubicin IV and Cyclophosphamide IV over 30-60 minutes on day 1 of weeks 1, 3, 5, and 7; and Paclitaxel IV over 3 hours on day 1 of weeks 9, 11, 13, and 15.	Total n=16 Participants Total of all reporting groups
Age, Customized 30-39 years	0 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	1 Participants n=4 Participants
Age, Customized 40-49 years	1 Participants n=5 Participants	2 Participants n=7 Participants	1 Participants n=5 Participants	4 Participants n=4 Participants
Age, Customized 50-59 years	3 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	4 Participants n=4 Participants
Age, Customized 60-69 years	0 Participants n=5 Participants	1 Participants n=7 Participants	4 Participants n=5 Participants	5 Participants n=4 Participants
Age, Customized 70-79 years	1 Participants n=5 Participants	1 Participants n=7 Participants	0 Participants n=5 Participants	2 Participants n=4 Participants
Sex: Female, Male Female	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Sex: Female, Male Male	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	5 Participants n=5 Participants	6 Participants n=7 Participants	5 Participants n=5 Participants	16 Participants n=4 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	1 Participants n=5 Participants	2 Participants n=7 Participants	0 Participants n=5 Participants	3 Participants n=4 Participants
Race (NIH/OMB) White	4 Participants n=5 Participants	4 Participants n=7 Participants	5 Participants n=5 Participants	13 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment United States	5 participants n=5 Participants	6 participants n=7 Participants	5 participants n=5 Participants	16 participants n=4 Participants