Clinical trial NCT00503750: Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™)
Official title: Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Breast Cancer
Keywords: Breast Cancer
Lead sponsor: Emory University
Sponsor class: OTHER
First posted: 2007-07-19
Enrollment: 27
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NON_RANDOMIZED
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

Brief summary: This is a phase II one arm study. Patients with HER2 (Human Epidermal Growth Factor Receptor 2)positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

Detailed description: This is a phase II one arm study. Patients with HER2(Human Epidermal Growth Factor Receptor 2) positive early stage breast cancer will receive ABI-007 and vinorelbine in combination with trastuzumab before having breast surgery.

Approximately 50 patients will take part at multi-sites with potentially 20 patients participating at the Emory Winship Cancer Institute, Grady Memorial Hospital, and Emory Crawford Long Hospital in Atlanta, Georgia.

Eligibility criteria: Inclusion Criteria:

* Histologically or cytologically confirmed invasive breast carcinoma.
* Early stage breast cancer - stage I (tumor size greater than 1 cm), II and IIA.
* 3+ HER2 overexpression by IHC or 2+ HER2 overexpression and FISH positivity.
* Patients must have measurable disease as defined by palpable lesion with both diameters greater than or equal to 1 cm measurable with caliper and/or a positive mammogram or ultrasound with at least one dimension greater than or equal to 1 cm. Bilateral mammogram and clip placement is required for study entry. Baseline measurements of the indicator lesions must be recorded on the patient registration form. To be valid for baseline, the measurements must have been made within the 14 days (4-6 weeks for x-rays and scans) immediately preceding patient's entry in study.
* ECOG performance status 0 to 2 within 14 days of study entry.
* Normal (greater than 50%) left ventricular ejection fraction (LVEF) by MUGA scan or echocardiography.
* Must be 18 years of age or older.
* Women or men of childbearing potential must use a reliable and appropriate contraceptive method. Postmenopausal women must be amenorrheic for at least 12 months to be considered of non-childbearing potential.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Exclusion Criteria:

* Evidence of disease outside the breast or chest wall, except ipsilateral axillary lymph nodes.
* Prior chemotherapy, hormonal therapy, biologic therapy or radiation therapy for breast cancer. Patients with history of DCIS are eligible if they were treated with surgery alone.
* Medical, psychological, or surgical condition which the investigator feels might compromise study participation.
* Pregnant or lactating women are not eligible.
* Patients with history of previous or current malignancy at other sites with the exception of adequately treated carcinoma in situ of the cervix or basal or squamous cell carcinoma of the skin. Patients with a history of other malignancies who remain disease free for greater than five years are eligible.
* Evidence of sensory and/or peripheral neuropathy.
* Serious, uncontrolled, concurrent infections.
* Major surgery within 4 weeks of the start of study treatment without complete recovery.
* Final eligibility for a clinical trial is determined by the health professionals conducting the trial.

Primary outcomes:
measure: Number of Participants With Complete Pathologic Response.
timeFrame: assess at 8 weeks
Secondary outcomes:
measure: Number of Participants Who Had Complete Clinical Resposnse, Partial Response and Stable Disease.
timeFrame: clinic examination every 2 weeks, evaluated every 3 months for 2 years post-op
Other outcomes:
Locations:
city: Atlanta
country: United States
facility: Piedmont Hospital Research Institute
state: Georgia
city: Atlanta
country: United States
facility: Emory University Winship Cancer Institute
state: Georgia
Study officials:
affiliation: Emory University Winship Cancer Institute
name: Ruth O'Regan, MD
role: PRINCIPAL_INVESTIGATOR
References: