Overview

Neoadjuvant Biweekly Treatment Followed by Weekly Treatment of Breast Cancer

Status:
Completed
Trial end date:
2012-07-01
Target enrollment:
0
Participant gender:
Female
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 carboplatin weekly for a total of 12 doses with one week rest after every 3 weeks of treatment over 12 weeks. Patients who are her-2 over-expressors by FISH (fluorescence in situ hybridization) will also receive Trastuzumab with weekly carboplatin and paclitaxel as the combination TC±H has been found to be synergistic in advanced breast cancer with improved clinical outcome.
Phase:
Phase 2
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
Rita Sanghvi, Mehta
University of California, Irvine
Treatments:
Albumin-Bound Paclitaxel
Carboplatin
Cyclophosphamide
Doxorubicin
Liposomal doxorubicin
Paclitaxel
Trastuzumab
Criteria
Eligibility Criteria:

1. 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.

2. 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.

3. Physical examination, chest x-ray and any x-rays or scans needed for tumor assessment
must be performed within 90 days prior to registration.

4. 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.

5. 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.

6. 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.

7. Patients must have a performance status of 0-2 by Zubrod criteria

8. 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.

9. 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.