Trial Outcomes & Findings for Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer (NCT NCT00203502)

NCT ID: NCT00203502

Last Updated: 2016-05-11

Results Overview

Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 40 participants
• Primary outcome timeframe: Participants were assessed during surgery, an average of one hour
• Results posted on: 2016-05-11

Participant Flow

This study recruited patients from September 9, 2005 through January 17, 2008. Patients were recruited from hematology/oncology clinic at the Winthrop P. Rockefeller Cancer Institute of the University of Arkansas for Medical Sciences.

Participant milestones

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Overall Study STARTED	40
Overall Study COMPLETED	39
Overall Study NOT COMPLETED	1

Reasons for withdrawal

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Overall Study Death	1

Baseline Characteristics

Primary Systemic Therapy in Operable/Locally Advanced Breast Cancer

Baseline characteristics by cohort

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=40 Participants Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	29 Participants n=5 Participants
Age, Categorical >=65 years	11 Participants n=5 Participants
Age, Continuous	45 years n=5 Participants
Sex: Female, Male Female	40 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	40 participants n=5 Participants

PRIMARY outcome

Timeframe: Participants were assessed during surgery, an average of one hour

Pathological complete response was defined as the absence of residual invasive and in situ cancer on hematoxylin and eosin evaluation of the resected breast.

Outcome measures

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=39 Participants Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Percentage of Participants With Pathological Complete Response.	41 percentage of evaluable patients Interval 27.7 to 55.4

SECONDARY outcome

Timeframe: At completion of chemotherapy treatment, an average of one hour

Population: All participants evaluated surgically

Clinical complete response was defined using RECIST response categories as the clinical response to chemotherapy

Outcome measures

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=38 Participants Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Number of Participants With Clinical Complete Response in Breast and the Axillary Lymph Nodes After the Completion of Chemotherapy and Bevacizumab.	53 percentage of pts w/ cCR Interval 39.0 to 66.0

SECONDARY outcome

Timeframe: After each chemotherapy infusion, approximately one hour

Percent of participants who had at least one grade 3 or 4 adverse event

Outcome measures

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=39 Participants Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Percentage of Participants With Grade 3 or 4 Adverse Events	79 percentage of pts w/ grade 3/4 AE Interval 69.0 to 90.0

SECONDARY outcome

Timeframe: Immediately before treatment and 1 year after start of treatment

Absolute change in LVEF, where LVEF values are measured in percentage units

Outcome measures

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=34 Participants Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
To Measure the Change in Left Ventricular Ejection Fraction (LVEF) From Baseline	-3.5 Percentage of LVEF Standard Deviation 7.0

SECONDARY outcome

Timeframe: at surgery, one day

Population: Patients with triple negative breast cancer

pCR rate for triple negative patients--percent

Outcome measures

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=14 Participants Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Percentage of Participants With Pathologic Complete Response (pCR) Among Those With Triple Negative Breast Cancer	57 % pCR among triple negative pts Interval 35.0 to 79.0

Adverse Events

Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin

Serious events: 39 serious events

Other events: 19 other events

Deaths: 0 deaths

Serious adverse events

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=39 participants at risk Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Infections and infestations infection	7.7% 3/39 • Number of events 3 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Respiratory, thoracic and mediastinal disorders pulmonary embolism	2.6% 1/39 • Number of events 1 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Musculoskeletal and connective tissue disorders Musculoskeletal pain	15.4% 6/39 • Number of events 10 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
General disorders Fatigue	10.3% 4/39 • Number of events 8 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Gastrointestinal disorders Diarrhea	7.7% 3/39 • Number of events 4 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Gastrointestinal disorders Nausea/vomiting	10.3% 4/39 • Number of events 4 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Gastrointestinal disorders Mucositis	7.7% 3/39 • Number of events 3 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Psychiatric disorders Insomnia	7.7% 3/39 • Number of events 3 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Vascular disorders Hypertension	7.7% 3/39 • Number of events 3 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Infections and infestations Urinary tract infection	5.1% 2/39 • Number of events 2 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Psychiatric disorders Anxiety	5.1% 2/39 • Number of events 2 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Psychiatric disorders Depression	5.1% 2/39 • Number of events 2 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Nervous system disorders Syncope	2.6% 1/39 • Number of events 1 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Blood and lymphatic system disorders Febrile Neutropenia	2.6% 1/39 • Number of events 1 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Cardiac disorders Heart failure	2.6% 1/39 • Number of events 1 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.

Other adverse events

Measure	Intervention: Drug:Docetaxel + Cyclophosphamide + Avastin n=39 participants at risk Docetaxel 75mg/m2 + Cyclophosphamide 500 mg/m2 \+ Avastin 15 mg/kg Q 3 weeks X 4 cycles Bevacizumab/Avastin: IV 15mg/kg 21 days Cyclophosphamide: 500mg per meter squared, IV every 21 days Doxorubicin: 60 mg per meter squared, IV every 21 days
Skin and subcutaneous tissue disorders Alopecia	48.7% 19/39 • Number of events 19 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
Gastrointestinal disorders Constipation	48.7% 19/39 • Number of events 19 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.
General disorders Fatigue	48.7% 19/39 • Number of events 19 If a subject experienced more than 1 of a given AE, the subject is only counted once for that AE. If a subject experienced more than one AE is a system organ class, the subject is only counted once in that system organ class.

Additional Information

Dr. Issam Makhoul

University of Arkansas for Medical Sciences

Phone: 5016868274

Email: MakhoulIssam@uams.edu

Results disclosure agreements

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