Trial Outcomes & Findings for Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility (NCT NCT00591851)

NCT ID: NCT00591851

Last Updated: 2023-09-25

Results Overview

LVEF by Muga scan

• Recruitment status: COMPLETED
• Study phase: PHASE2
• Target enrollment: 70 participants
• Primary outcome timeframe: Baseline-18 months
• Results posted on: 2023-09-25

Participant Flow

Protocol Open to Accrual 12/20/2004 Protocol Closed to Accrual 07/25/2006 Primary Completion Date 06/24/2008 Recruitment Location is the medical clinic.

Participant milestones

Measure	AC Followed by Paclitaxel + Trastuzumab Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
Overall Study STARTED	70
Overall Study COMPLETED	64
Overall Study NOT COMPLETED	6

Reasons for withdrawal

Measure	AC Followed by Paclitaxel + Trastuzumab Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
Overall Study Withdrawal by Subject	3
Overall Study Adverse Event	2
Overall Study Progressive Disease	1

Baseline Characteristics

Phase II Study of Dose-Dense Doxurubicin and Cyclophosphamide (AC) Followed By Paclitaxel With Trastuzumab in HER2/ NEU-Amplified Breast Cancer: Feasibility

Baseline characteristics by cohort

Measure	AC Followed by Paclitaxel + Trastuzumab n=70 Participants Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
Age, Continuous	49 years n=5 Participants
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	63 Participants n=5 Participants
Age, Categorical >=65 years	7 Participants n=5 Participants
Sex: Female, Male Female	70 Participants n=5 Participants
Sex: Female, Male Male	0 Participants n=5 Participants
Region of Enrollment United States	70 participants n=5 Participants

PRIMARY outcome

Timeframe: Baseline-18 months

LVEF by Muga scan

Outcome measures

Measure	AC Followed by Paclitaxel + Trastuzumab n=70 Participants Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
Cardiac Saftey LVEF at Baseline	68 percentage of LVEF Interval 55.0 to 81.0
Cardiac Saftey LVEF at Month 6 (67/70 pts)	66 percentage of LVEF Interval 52.0 to 75.0
Cardiac Saftey LVEF at Month 9 (68/70 pts)	65 percentage of LVEF Interval 50.0 to 75.0
Cardiac Saftey LVEF at Month 18 (48/70 pts)	66 percentage of LVEF Interval 57.0 to 75.0
Cardiac Saftey LVEF at Month 2	67 percentage of LVEF Interval 58.0 to 79.0

Adverse Events

AC Followed by Paclitaxel + Trastuzumab

Serious events: 19 serious events

Other events: 48 other events

Deaths: 0 deaths

Serious adverse events

Measure	AC Followed by Paclitaxel + Trastuzumab n=70 participants at risk Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
Gastrointestinal disorders Abdominal Pain	2.9% 2/70 • Number of events 2
Metabolism and nutrition disorders Hyperglycemia	1.4% 1/70 • Number of events 1
General disorders Non Cardiac-Chest pain	2.9% 2/70 • Number of events 2
Metabolism and nutrition disorders Dehydration	1.4% 1/70 • Number of events 1
Gastrointestinal disorders Diarrhea	1.4% 1/70 • Number of events 1
Respiratory, thoracic and mediastinal disorders Dyspnea	4.3% 3/70 • Number of events 3
Blood and lymphatic system disorders Febrile Neutropenia	5.7% 4/70 • Number of events 4
General disorders Fever	5.7% 4/70 • Number of events 4
Vascular disorders Hypotension	1.4% 1/70 • Number of events 1
Gastrointestinal disorders Lower gastrointestinal hemorrhage	1.4% 1/70 • Number of events 1
Respiratory, thoracic and mediastinal disorders Nasal congestion	1.4% 1/70 • Number of events 1
Gastrointestinal disorders Nausea	1.4% 1/70 • Number of events 1
Investigations Neutrophil count decreased	1.4% 1/70 • Number of events 1
Cardiac disorders Pericarditis	1.4% 1/70 • Number of events 1
Respiratory, thoracic and mediastinal disorders Pneumonia	1.4% 1/70 • Number of events 1
Cardiac disorders Sinus bradycardia	1.4% 1/70 • Number of events 1
Infections and infestations Skin infection	1.4% 1/70 • Number of events 1
Nervous system disorders Syncope	1.4% 1/70 • Number of events 1
Vascular disorders Thrombosis	1.4% 1/70 • Number of events 1

Other adverse events

Measure	AC Followed by Paclitaxel + Trastuzumab n=70 participants at risk Doxorubicin and Cyclophosphamide (60/600 mg/m2) X 4 followed by Paclitaxel (175 mg/m2) X 4 every 2 weekly with pegfilgrastim (6mg on day 2) + Trastuzumab x 1 year.
Investigations Alanine aminotransferase increased	8.6% 6/70 • Number of events 7
General disorders Fatigue	40.0% 28/70 • Number of events 44
Skin and subcutaneous tissue disorders Alopecia	22.9% 16/70 • Number of events 17
Blood and lymphatic system disorders Anemia	27.1% 19/70 • Number of events 43
Investigations White blood cell decreased	14.3% 10/70 • Number of events 18
Gastrointestinal disorders Nausea	18.6% 13/70 • Number of events 15
Investigations Neutrophil count decreased	10.0% 7/70 • Number of events 11
Musculoskeletal and connective tissue disorders Bone pain	14.3% 10/70 • Number of events 13

Additional Information

Dr. Chau Dang

Memorial Sloan-Kettering Cancer Center

Phone: 914-367-7181

Email: dangc@mskcc.org

Results disclosure agreements

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