Breast Cancer
Conditions
Keywords
breast cancer, adenocarcinoma of the breast, cardiac safety, Breast cancer patients seen at the Memorial Sloan-Kettering Cancer Center
Brief summary
HER-2/neu (+) breast cancer is a more aggressive form of breast cancer. HER-2/neu is a protein that is overproduced by your tumor. It makes your cancer more aggressive. Standard treatments for this type of cancer will help some people, but there is a moderate to high chance that your cancer may come back. The purpose of this study is to see if a new regimen will be effective in preventing cancer from coming back. This is a phase II trial. In this trial, patient get a drug regimen that has been tested in small groups of people to see what dose is safe. Researchers now wish to see how effective the drug is for HER-2/neu (+) breast cancer. The objective includes looking at short-term side effects and risks of the drug. All of the drugs on this regimen can affect the heart which can be a serious side effect. The drugs affect on heart function is a primary focus.
Interventions
DRUGAC [Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)] Followed By Paclitaxel (P)
AC \[Adriamycin (A) (also known as doxorubicin) and Cyclophosphamide (C)\] Followed By Paclitaxel (P)
Sponsors
Memorial Sloan Kettering Cancer Center
Amgen
Genentech, Inc.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
FEMALE
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* adenocarcinoma breast cancer * ECOG performance status of 0 or 1 * peripheral neuropathy less than or equal to 1 * discontinued hormonal therapy as a chemoprevention while onstudy * LVEF by MUGA \> 55%? * Absolute neutrophil count (ANC)\> 1000/µL) * platelet count \> 100,000/µL) * SGOT OR SGPT \< 92.5 units/L
Exclusion criteria
* Stage IV breast cancer * any chemotherapy, radiation therapy, immunotherapy, or biotherapy for a CURRENT breast cancer * pregnant or lactating patients * active second malignancy, other than adequately treated non-melanoma skin cancers or in situ cervical cancer * previous allergy/hypersensitivity to Doxorubicin, Cyclophosphamide, Paclitaxel, or other drugs formulated in Cremophor EL? * unstable angina, congestive heart failure, current use of digitalis, beta-blockers, or calcium blockers for therapy of congestive heart failure, arrhythmia requiring medical therapy, or a history of a myocardial infarction within 12 months * psychiatric illness that prevents her from understanding the nature of this study and complying with protocol requirements? * active, unresolved infections * sensitivity to E. coli derived proteins * prior chemotherapy with an anthracycline * prior Herceptin therapy
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Cardiac Saftey | Baseline-18 months | LVEF by Muga scan |
Countries
United States
Participant flow
Recruitment details
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.
Participants by arm
| Arm | Count |
|---|---|
| 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. | 70 |
| Total | 70 |
Withdrawals & dropouts
| Period | Reason | FG000 |
|---|---|---|
| Overall Study | Adverse Event | 2 |
| Overall Study | Progressive Disease | 1 |
| Overall Study | Withdrawal by Subject | 3 |
Baseline characteristics
| Characteristic | AC Followed by Paclitaxel + Trastuzumab |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 7 Participants |
| Age, Categorical Between 18 and 65 years | 63 Participants |
| Age, Continuous | 49 years |
| Region of Enrollment United States | 70 participants |
| Sex: Female, Male Female | 70 Participants |
| Sex: Female, Male Male | 0 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | — / — |
| other Total, other adverse events | 48 / 70 |
| serious Total, serious adverse events | 19 / 70 |
Outcome results
Primary
Cardiac Saftey
LVEF by Muga scan
Time frame: Baseline-18 months
| Arm | Measure | Group | Value (MEDIAN) |
|---|---|---|---|
| AC Followed by Paclitaxel + Trastuzumab | Cardiac Saftey | LVEF at Baseline | 68 percentage of LVEF |
| AC Followed by Paclitaxel + Trastuzumab | Cardiac Saftey | LVEF at Month 2 | 67 percentage of LVEF |
| AC Followed by Paclitaxel + Trastuzumab | Cardiac Saftey | LVEF at Month 6 (67/70 pts) | 66 percentage of LVEF |
| AC Followed by Paclitaxel + Trastuzumab | Cardiac Saftey | LVEF at Month 9 (68/70 pts) | 65 percentage of LVEF |
| AC Followed by Paclitaxel + Trastuzumab | Cardiac Saftey | LVEF at Month 18 (48/70 pts) | 66 percentage of LVEF |