Status:
COMPLETED
Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer
Lead Sponsor:
Rita Sanghvi, Mehta
Conditions:
Breast Cancer
Eligibility:
FEMALE
18+ years
Phase:
PHASE2
Brief Summary
We proposed to use 4 cycles of AC q 2 weeks, as used in the dose dense adjuvant study with GM-CSF support on days 3-9 of the cycle. After the completion of AC we plan to administer paclitaxel and carb...
Detailed Description
Neoadjuvant chemotherapy, also termed primary, induction, or preoperative chemotherapy, is defined as chemotherapy administered before locoregional treatment. It was first used in locally advanced bre...
Eligibility Criteria
Inclusion
- Eligibility Criteria:
- Patients must be women with a histologically confirmed diagnosis of locally advanced or inflammatory breast carcinoma. Histologic confirmation shall be by either core needle biopsy or incisional biopsy. Punch biopsy is allowed if invasive breast cancer is documented.
- Patients must meet one of the criteria defined below (indicate one):
- a .Selected Stage IIB (T3, N0, M0) or IIIA (T3, N1-2, M0) disease judged primarily unresectable by an experienced breast surgeon; or otherwise deemed appropriate candidates for neoadjuvant treatment.
- b. Stage IIIB (T4, Any N, M0) or (Any T, N3, M0) disease.
- Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment must be performed within 90 days prior to registration.
- Patients with the clinical diagnosis of congestive heart failure or angina pectoris are NOT eligible. Patients with hypertension or age \> 60 years must have a Multiple Gated Acquisition (MUGA) or echocardiogram scan performed within 90 days prior to registration (indicate not applicable (NA) if no MUGA required) and Left Ventricular Ejection Fraction (LVEF) % must be greater than the institutional lower limit of normal.
- Patients must have a serum creatinine and bilirubin ≤ the institutional upper limit of normal, and an Serum glutamic oxaloacetic transaminase (SGOT) or Serum glutamic pyruvic transaminase (SGPT) ≤ 2x the institutional upper limit of normal. These tests must have been performed within 90 days prior to registration.
- Patients must have an Absolute neutrophil count (ANC) of ≥ 1,500/μl and a platelet count of ≥ 100,000/μl. These tests must have been performed within 90 days prior to registration.
- Patients must have a performance status of 0-2 by Zubrod criteria
- Pregnant or nursing women may not participate due to the possibility of fetal harm or of harm to nursing infants from this treatment regimen. Women of reproductive potential may not participate unless they have agreed to use an effective contraceptive method. A urine pregnancy test is required for women of childbearing potential.
- All patients must be informed of the investigational nature of this study and must sign and give written informed consent in accordance with institutional and federal guidelines.
Exclusion
Key Trial Info
Start Date :
April 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
July 1 2012
Estimated Enrollment :
48 Patients enrolled
Trial Details
Trial ID
NCT00256243
Start Date
April 1 2004
End Date
July 1 2012
Last Update
March 2 2018
Active Locations (1)
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1
Chao Family Comprehensive Cancer Center
Orange, California, United States, 92868