Effect of Chemotherapy and Radiation Prior to Surgery for Triple Negative Breast Cancer

The Washington University

Status and phase: Terminated; Phase 2

Conditions: Breast Cancer

Treatments: Procedure: Mastectomy; Drug: Cisplatin; Radiation: Radiation Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00603408

07-0913

Details and patient eligibility

About

The purpose of this study is to determine whether Cisplatin when given with radiation therapy prior to surgery is effective in improving response to treatment in breast cancer patients. Tumor, blood and bone marrow samples will be collected in this study and will also help researchers determine if cisplatin is able to change tumor DNA so it cannot multiply itself and create more tumor cells, and cause the tumor cells to die.

Full description

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/m^2 (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/m^2 (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/m^2 (cycle 3)

Week 10: Chemo Day 1:Cisplatin 75mg/m^2 (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/m^2 & Cyclophosphamide: 600mg/m^2, every 2 weeks for 4 cycles

Week 21 - 29: Recommended (physician discretion) Adjuvant Chemo Paclitaxel: 175mg/m^2 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

Enrollment: 5 patients

Sex: Female

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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5 participants in 1 patient group

Cisplatin + Radiation + Recommended Surgery

Experimental group

Description:

Cisplatin 75 mg/m\^2 IV Day 1 Week 1, Day 1 Week 2, Day 1 Week 7, Day 1 Week 10 Radiation = Total dose to breast or chest wall will be 50-60 Gy in 1.8-2.0 Gy daily fractions. Internal mammary nodes, supraclavicular fossa nodes and axillary nodal basins will receive 45-50 Gy over 5-6 weeks. Surgery (recommended) mastectomy with/without axillary lymph node dissection

Treatment:

Procedure: Mastectomy

Drug: Cisplatin

Radiation: Radiation Therapy