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Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters


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

Thank you

Trial Information

Effect of Neoadjuvant Cisplatin Based Chemoradiation Therapy for Locally Advanced Triple Negative Breast Cancer: Clinical Outcome and Correlation to Biological Parameters


After Diagnosis: Clinical Stage IIB, III Breast Cancer, Triple Negative

Week 0: Port-A-Cath placement Tumor biopsy (Core and FNA) Blood collection Bone marrow
aspiration Sentinel Lymph node biopsy, if axillary US negative

Week 1: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m2 (cycle 1) Days 2-5:
Radiation Therapy

Week 2: Radiation Day 1-5: Radiation Therapy

Week 3: Radiation Days 1-5: Radiation Therapy

Week 4: Chemo & Radiation Day 1: Radiation Therapy, Cisplatin 75mg/m2 (cycle 2) Days 2-5:
Radiation Therapy

Week 5: Radiation Days 1-5: Radiation Therapy

Week 6: Radiation Days 1-5: Radiation Therapy

Week 7: Chemo Day 1: Cisplatin 75mg/m2 (cycle 3)

Week 10: Chemo Day 1:Cisplatin 75mg/m2 (cycle 4)

Week 13: Surgery Mastectomy with/without axillary lymph node dissection Tumor biopsy (Core
and FNA) Blood collection Bone marrow aspiration

Week 15 - 21: Recommended (physician discretion) Adjuvant Chemo Dose dense Doxorubicin:
60mg/m2 & Cyclophosphamide: 600mg/m2, every 2 weeks for 4 cycles

Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m2 every 2
weeks for 4 cycles

Week 52 IVAD Removal, Bone marrow aspiration

Follow-Up (up to 5 years) Q 3 months for year 1 Q 6 months for year 2-3 Q 1 year for years
4-5


Inclusion Criteria:



- Patients must be >= 18 years of age

- Patients must be newly diagnosed with primary invasive ductal breast adenocarcinoma.

- Tumor classified as clinically stage T2, T3 or T4 with any N (NX, N1, N2, or N3).

- Tumor does not express the following biomarkers: estrogen receptor, progesterone
receptor, Her2/neu

- Adequate organ function defined as:

- Serum Creatinine <= 1.5 x upper limit of institutional normal.

- ALT, AST, ALK Phos <= 1.5 x upper limit of institutional normal.

- Bilirubin <= 1.5 x upper limit of institutional normal.

- Normal left ventricular function (LVEF > 50%) by MUGA or ECHO.

Exclusion Criteria:

- No evidence of distant metastasis present by CT, Bone scan, or physical exam. If the
bone scan or CT scans demonstrate indeterminate lesions, the nature of these lesions
should be further clarified by additional testing such as PET or MRI.

- No prior malignancies with the exception of curatively treated basal or squamous
carcinoma of the skin or history of previous malignancies, treated with at least
greater than 5 years disease free survival.

- Women of child bearing potential may not be currently pregnant or breastfeeding at
time of registration and must agree to use adequate contraception.

- Karnofsky Performance Status of <= 70.

- Patients with known history neural deficiencies (e.g. peripheral neuropathy).

- Patients with a known hearing impairment (hearing loss or severe tinnitus).

- Male patients

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:

Clinical response rate in patients with locally advanced TN tumors who received radiation combined with cisplatin

Outcome Description:

Obtain preliminary information on the relationship between tumor response in patients with locally advanced triple negative breast cancer treated with cisplatin based chemoradiation correlates with deficiencies in DNA repair mechanisms.

Outcome Time Frame:

5 years

Safety Issue:

No

Principal Investigator

Rebecca Aft, MD, PhD

Investigator Role:

Principal Investigator

Investigator Affiliation:

Washington University School of Medicine

Authority:

United States: Institutional Review Board

Study ID:

07-0913

NCT ID:

NCT00603408

Start Date:

December 2007

Completion Date:

December 2009

Related Keywords:

  • Breast Cancer
  • Breast Cancer
  • Locally Advanced
  • Neoadjuvant
  • Breast Neoplasms

Name

Location

Washington University School of MedicineSaint Louis, Missouri  63110