Phase 2
N=30
Neoadjuvant Chemotherapy + Herceptin in HER2 Positive Stage II-III Breast Cancer Patients
Breast Neoplasm
Bottom Line
View on ClinicalTrials.gov: NCT00270894 ↗Enrolled (actual)
30
Serious AEs
13.3%
Results posted
Mar 2012
Primary outcome: Primary: Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule — 60 percentage of participants
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- epirubicin (Drug); cyclophosphamide (Drug); docetaxel (Drug); trastuzumab (Drug)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- Female
- Sponsor
- Accelerated Community Oncology Research Network
- Primary completion
- Aug 2011
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Percentage of Subjects Able to Complete > 85% of the Planned Dose on Schedule |
60 | — |
| PRIMARY Frequency of Grade 3 or 4 Hematologic and Nonhematologic Toxicities |
2; 11; 0; 0 | — |
| SECONDARY Pathologic Response |
16; 9; 3 | — |
| SECONDARY Clinical Response Prior to Surgery |
20; 5; 2 | — |
| SECONDARY Left Ventricular Ejection Fraction (LVEF) |
63.55; 61.94; 56.88; 57.68; 58.15; 59.38 | — |
| SECONDARY Progression-free Survival (PFS) |
NA | — |
| SECONDARY Overall Survival (OS) |
NA | — |
Summary
The purpose of this study is to evaluate the effectiveness and tolerability of the combination of the following medications given every two weeks in HER2 positive breast cancer patients:
* trastuzumab (Herceptin)
* epirubicin (Ellence)
* cyclophosphamide (Cytoxan)
* docetaxel (Taxotere)
Eligibility Criteria
Inclusion Criteria
- Non-pregnant females =/> 18 years of age
- Non-inflammatory breast cancer stage IIA - IIIC or high risk node negative
- Core biopsy of breast demonstrating invasive cancer and documented ER/PgR receptor status
- Normal cardiac function and adequate hematologic function
- Human epidermal growth factor receptor 2 protein (HER2) positive
- No evidence of metastatic disease
- ECOG Performance Status 0 - 1
- Women of childbearing potential must agree to using effective contraception while on treatment and for at least 3 months post-treatment
Exclusion Criteria
- Treated with other investigational drugs within 30 days
- Uncontrolled intercurrent disease or active infection
- Known sensitivity to e. coli-derived proteins or polysorbate 80
- Psychiatric illness or social situation that would limit study compliance
- Pre-existing peripheral neuropathy > Grade 1
- Cancer within 5 years of screening with the exception of surgically cured nonmelanomatous skin cancer; in-situ carcinoma of the cervix; or in-situ carcinoma of the breast
- Bilateral synchronous breast cancer
- Inflammatory breast cancer
- Women who are pregnant or breast feeding
Data sourced from ClinicalTrials.gov (NCT00270894). 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.