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Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer


Phase 2
18 Years
N/A
Not Enrolling
Both
Breast Cancer

Thank you

Trial Information

Phase II Neoadjuvant Trial of Trastuzumab in Combination With Dose-Dense ABI-007 (Abraxane™) Followed by Vinorelbine for HER2 Overexpressing Early Stage Breast Cancer


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.


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.

Type of Study:

Interventional

Study Design:

Allocation: Non-Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment

Outcome Measure:

Number of Participants With Complete Pathologic Response.

Outcome Description:

Pathologic complete response (pCR): Absence of invasive breast cancer in the breast (mastectomy or lumpectomy) specimen at the time of definitive surgery. Presence of in situ cancer alone will be considered a pCR. Although clinical examination is the primary method of determining response, radiologic assessments (mammogram, ultrasound ± MRI) may be used to confirm response/non-response.

Outcome Time Frame:

assess at 8 weeks

Safety Issue:

Yes

Principal Investigator

Ruth O'Regan, MD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Emory University Winship Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

0495-2006

NCT ID:

NCT00503750

Start Date:

April 2008

Completion Date:

July 2011

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Breast Neoplasms

Name

Location

Emory University Winship Cancer Institute Atlanta, Georgia  30322
Piedmont Hospital Research Institute Atlanta, Georgia  30309