Phase 3
Completed N=280
Combination Chemotherapy and Paclitaxel Plus Trastuzumab in Treating Women With Palpable Breast Cancer That Can Be Removed by Surgery
HER2/Neu Positive · Stage IA Breast Cancer · Stage IB Breast Cancer · Stage II Breast Cancer
Source: ClinicalTrials.gov NCT00513292 ↗
Enrolled (actual)
280
Serious AEs
16.1%
Results posted
Sep 2015
Primary outcomePrimary: pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy — 56.5; 54.2 percentage of participants — p=.7
Summary
This randomized phase III trial is studying giving fluorouracil together with epirubicin and cyclophosphamide followed by paclitaxel and trastuzumab to see how well it works compared with giving paclitaxel together with trastuzumab followed by fluorouracil, epirubicin, cyclophosphamide, and trastuzumab in treating women with palpable breast cancer that can be removed by surgery. Drugs used in chemotherapy work in different ways to stop the growth of tumor cells, either by killing the cells or by stopping them from dividing. Monoclonal antibodies, such as trastuzumab, can block tumor growth in different ways. Some block the ability of tumor cells to grow and spread. Others find tumor cells and help kill them or carry tumor-killing substances to them. It is not yet known whether it is more effective to give combination chemotherapy before or after treatment with paclitaxel plus trastuzumab.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY pCR Within the Breast, Defined as no Evidence of Invasive Tumor Remaining in the Breast at Surgery Following Completion of Chemotherapy |
56.5; 54.2 | .7 |
| SECONDARY Combined pCR Rate in the Breast and Axillary Lymph Nodes Defined as no Evidence of Invasive Tumor Remaining in Either the Breast or Axillary Nodes at Surgery Following Completion of Chemotherapy |
48.3; 46.7 | — |
| SECONDARY Asymptomatic Decreases From Baseline in Left Ventricular Ejection Fraction (LVEF) at Week 12 |
92.3; 82.5; 0.8; 0; 6.2; 11.7 | — |
| SECONDARY Asymptomatic Decreases From Baseline in LVEF at Week 24 |
83.3; 73.1; 0.8; 3.1; 7.9; 15.4 | — |
| SECONDARY LVEFs From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans as Reported at 12 Week |
2; -3 | — |
| SECONDARY Change in LVEFs (From Regularly Scheduled Multi Gated Acquisition Scan (MUGA)/Echo Scans) From Baseline and at 24 Week |
-3; -4 | — |
| SECONDARY Breast Conservation |
37.7; 39.1 | — |
| SECONDARY Disease-free Survival (DFS) |
NA; NA | — |
| SECONDARY Overall Survival (OS) |
NA; NA | — |
Eligibility Criteria
Inclusion Criteria
- Diagnosis of invasive adenocarcinoma by core needle biopsy
- Fine needle aspiration allowed provided primary tumor size ULN but ≤ 2.5 times ULN allowed if bone scans fail to demonstrate metastatic disease
- Suspicious findings on bone scan must be confirmed as benign by x-ray, MRI, or biopsy
- Prior non-breast malignancies allowed if disease-free for 5 years since completion of initial treatment regimen and deemed by their physician to be at low risk for recurrence
- Patients who had the following cancers are eligible if diagnosed and treated within the past 5 years:
- Carcinoma in situ of the cervix
- Colon carcinoma in situ
- Melanoma in situ
- Basal cell and squamous cell carcinoma of the skin
- No cardiac disease that would preclude the use of epirubicin hydrochloride or trastuzumab (Herceptin®) including any of the following:
- Active cardiac disease
- Angina pectoris that requires the use of antianginal medication
- Cardiac arrhythmia requiring medication
- Severe conduction abnormality
- Clinically significant valvular disease
- Cardiomegaly on chest x-ray
- Ventricular hypertrophy on EKG
- Patient's with poorly controlled hypertension ( i.e., diastolic greater than 100 mm/Hg)
- Patients with hypertension that is well controlled on medication are eligible
- History of cardiac disease
- Myocardial infarction documented as a clinical diagnosis or by EKG or any other tests
- Documented congestive heart failure
- Documented cardiomyopathy
- No sensory or motor neuropathy ≥ grade 2, as defined by the NCI's CTCAE v3.0
- Women of reproductive potential must agree to use an effective non-hormonal method of contraception during therapy
- Women of child bearing potential must have a negative urine or serum pregnancy test within 2 weeks of registration
- Not pregnant or nursing
- No psychiatric or addictive disorders or other conditions that, in the opinion of the investigator, would preclude the patient from meeting the study requirements
- No non-malignant systemic disease (e.g., cardiovascular, renal, hepatic) that would preclude treatment with either of the treatment regimens
- No prior surgical axillary staging procedure
- Prior non-excisional biopsy of an axillary node allowed
- No prior treatment for this breast cancer
- Hormonal therapy allowed if had been given for up to a total of 28 days anytime after diagnosis and before study entry
- Hormonal therapy must stop at or before study entry and be re-started, if indicated, following surgery
- No prior therapy with anthracyclines or taxanes for any malignancy
- No other investigational agents within the past 30 days
- No concurrent sex hormonal therapy (e.g., birth control pills, ovarian hormonal replacement therapy)
- No concurrent therapy with any hormonal agent such as raloxifene, tamoxifen, or other selective estrogen receptor modulator (SERM), either for osteoporosis or breast cancer prevention
Data sourced from ClinicalTrials.gov (NCT00513292). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.